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European Commission approves DARZALEX® (daratumumab) as the first licensed treatment for patients with high-risk smouldering multiple myeloma
Landmark approval is based on results from the Phase 3 AQUILA study, showing fixed-duration treatment with daratumumab significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring1 This milestone marks a critical advance in early intervention for multiple myeloma as the first authorised treatment, offering a new treatment paradigm for patients with high-risk smouldering disease2 Beerse, Belgium, July 23, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved a new indication for DARZALEX® (daratumumab) subcutaneous (SC) formulation as monotherapy for the treatment of adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma.3 SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow.2,4,5 'Until now, the absence of approved therapies for high-risk smouldering multiple myeloma has left clinicians with limited options beyond observation, despite evidence that 50 percent of this patient population progress to active multiple myeloma within two years,' said Professor Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens School of Medicine.* 'The approval of daratumumab offers the potential to change this trajectory. By intervening earlier in the disease course, we have a meaningful opportunity to delay or prevent progression to symptomatic disease, reduce irreversible end-organ damage and extend the window of improved patient outcomes.' 'This new indication for daratumumab SC is an exciting step forward in addressing a long-standing unmet clinical need for those diagnosed with high-risk smouldering multiple myeloma and is the first time a treatment has been approved for this patient population,' said Ester in 't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'It means that eligible patients no longer have to live with the uncertainty or fear of waiting for progression to occur without active treatment, instead having the option to intercept the disease with therapeutic intervention.' The Phase 3 AQUILA study (NCT03301220) is the largest randomised study of a well-defined high-risk SMM population, evaluating the efficacy and safety of fixed-duration, monotherapy daratumumab SC (n=194) compared with active monitoring (n=196).1 At a median follow-up of 65.2 months (range, 0-76.6), patients who received daratumumab SC showed statistically significant improved progression-free survival (PFS; defined as progression to active multiple myeloma, as assessed according to the International Myeloma Working Group diagnostic criteria for multiple myeloma [SLiM-CRAB], or death) compared to patients who underwent active monitoring; 63.1 percent in the daratumumab arm versus 40.8 percent in the active monitoring arm remained alive and progression-free at 60 months (hazard ratio [HR], 0.49; 95 percent confidence interval [CI], 0.36-0.67; p<0.001).1 Among patients who were retrospectively categorised as having high-risk SMM, per the current Mayo 2018 criteria (20/2/20), median PFS was not reached in the daratumumab arm and was 22.1 months in the active monitoring arm (HR, 0.36; 95 percent CI, 0.23-0.58).1 Overall survival was also extended with daratumumab SC, with 5-year survival rates of 93.0 percent vs 86.9 percent for active monitoring (HR, 0.52; 95 percent CI, 0.27-0.98).1 Additionally, patients who received daratumumab SC saw a higher overall response rate of 63.4 percent compared to 2.0 percent with active monitoring (p<0.001).1 Median time to first-line multiple myeloma treatment was not reached for patients receiving daratumumab SC compared to 50.2 months with active monitoring (HR, 0.46; 95 percent CI, 0.33-0.62; nominal p<0.0001).1,6 Daratumumab demonstrated a safety profile consistent with previous studies of daratumumab in other indications, with a low rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs).1 Grade 3/4 TEAEs occurred in 40.4 percent of patients treated with daratumumab SC and 30.1 percent of patients actively monitored.1 The most common (≥5 percent in either group) Grade 3/4 TEAE was hypertension (5.7 percent vs 4.6 percent, respectively).1 The frequency of TEAEs leading to discontinuation of daratumumab SC was low (5.7 percent), as was the incidence of fatal TEAEs in both groups (1.0 percent vs 2.0 percent, respectively).1 'Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma,' said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'With today's approval, Johnson & Johnson has an innovative therapy for every stage of the disease. We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival. We remain steadfast in our mission to get in front of cancer.' About the AQUILA Study AQUILA (NCT03301220) is a randomised, multicentre Phase 3 study investigating daratumumab SC versus active monitoring in patients (n=390) with high-risk smouldering multiple myeloma (SMM).7 The primary endpoint is progression-free survival and secondary endpoints include time to progression, overall response rate and overall survival.7 Patients in the study were diagnosed with SMM in the last five years and were excluded if they had prior exposure to approved or investigational treatments for SMM or multiple myeloma.7 About Smouldering Multiple Myeloma SMM is an asymptomatic intermediate disease state of multiple myeloma where abnormal cells can be detected in the bone marrow.2,8 Patients living with SMM tend not to show signs or symptoms typically associated with active myeloma, such as bone pain, bone fractures, kidney problems, or anaemia, however as abnormal plasma cells are present, organ damage may begin and progress asymptomatically.1,9 Approximately 15 percent of all cases of newly diagnosed multiple myeloma are classified as SMM, and half of those diagnosed with high-risk SMM are estimated to progress to active multiple myeloma within two years.10 About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11,12 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.11,12 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.13 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy while remissions become progressively shorter.14,15,16 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.17 About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.18 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.19 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.19 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.19 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.19 Daratumumab may also have an effect on normal cells.19 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.20,21,22,23,24,25,26,27,28 For further information on daratumumab, please see the Summary of Product Characteristics at: About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc. and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Professor Meletios A. Dimopoulos, M.D., National and Kapodistrian University of Athens School of Medicine, has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work. 1 Dimopoulos MA, et al. Phase 3 Randomized Study of Daratumumab Monotherapy versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA study. Oral presentation. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024.2 Myeloma UK. Smouldering Myeloma. Available at: Last accessed: July 2025. 3 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. July 2025.4 Oben B, et al. Whole-Genome Sequencing Reveals Progressive Versus Stable Myeloma Precursor Conditions as Two Distinct Entities. Nature Communications. 2021; 12(1861).5 Maura F, et al. Targeting the Tumor and The Immune System in Smoldering Multiple Myeloma. The New England Journal of Medicine. 2025;392:1858-1860.6 Dimopoulos MA, et al. Phase 3 Randomized Study of Daratumumab Monotherapy Versus Active Monitoring in Patients With High-risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study. Abstract #773. American Society of Hematology (ASH) Annual Meeting; December 7-10, 2024. 7 A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma. Available at: . Last accessed: July 2025.8 WebMD. Smoldering Multiple Myeloma. Available at: Last accessed: July 20259 American Cancer Society. About Multiple Myeloma. Available at: Last accessed: July 2025.10 Rajkumar SV, et al. Smoldering Multiple Myeloma Current Treatment Algorithms. Blood Cancer J. 2022;12(9):129.11 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget. 2013;4(12):2186-2207.12 American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: Last accessed: July 2025.13 ECIS - European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: Last accessed: July 2025.14 Bhatt P, et al. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.15 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23.16 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.17 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: July 2025.18 J&J Data on File (RF-452129). Number of Patients Treated with DARZALEX Worldwide as of December 2024.19 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: Last accessed: July 2025.20 Moreau P, et al. Bortezomib, Thalidomide, and Dexamethasone With or Without Daratumumab Before and After Autologous Stem-Cell Transplantation for Newly Diagnosed Multiple Myeloma (CASSIOPEIA): A Randomised, Open-label, Phase 3 Study. Lancet. 2019;394(10192):29-38.21 Facon T, et al. MAIA Trial Investigators. Daratumumab Plus Lenalidomide and Dexamethasone for Untreated Myeloma. New England Journal of Medicine. 2019;380(22):2104-2115.22 Mateos MV, et al. Overall Survival with Daratumumab, Bortezomib, Melphalan, and Prednisone in Newly Diagnosed Multiple Myeloma (ALCYONE): A Randomised, Open-label, Phase 3 Trial. The Lancet. 2020;395:132-141.23 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab Plus Pomalidomide and Dexamethasone Versus Pomalidomide and Dexamethasone Alone in Previously Treated Multiple Myeloma (APOLLO): An Open-label, Randomised, Phase 3 Trial. Lancet Oncol. 2021;22(6):801-812.24 Palladini G, et al. Daratumumab Plus CyBorD for Patients with Newly Diagnosed AL Amyloidosis: Safety Run-in Results of ANDROMEDA. Blood 2020;2;136(1):71-80.25 Chari A, et al. Daratumumab Plus Pomalidomide and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma. Blood. 2017;130(8):974-981.26 Bahlis NJ, et al. Daratumumab Plus Lenalidomide and Dexamethasone in Relapsed/Refractory Multiple Myeloma: Extended Follow-up of POLLUX, A Randomized, Open-label, Phase 3 study. Leukemia. 2020;34(7):1875-1884.27 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Previously Treated Multiple Myeloma: Three-Year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk. 2020;20(8):509-518.28 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients with Transplant-Ineligible or Transplant-Deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral Presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. CP-529642 July 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Business Upturn
15-06-2025
- Business
- Business Upturn
Investigational combination of first-in-class bispecific antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) shows deep and durable responses in heavily pretreated multiple myeloma patients
Results from the Phase 2 RedirecTT-1 study demonstrate deep responses with 78.9 percent overall response rate through dual targeting of GPRC5D and BCMA1 Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs1 Advertisement BEERSE, BELGIUM, June 15, 2025 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, announced today new results from the Phase 2 RedirecTT-1 study evaluating the investigational combination of TALVEY®▼(talquetamab), the first European Commission (EC) approved GPRC5D-directed bispecific antibody, and TECVAYLI®▼(teclistamab), the first EC approved BCMA-directed bispecific antibody. The results show a high overall response rate (ORR) with durability in patients with triple-class exposed (TCE) relapsed/refractory multiple myeloma (RRMM) who have true extramedullary disease (EMD).1 EMD is defined as soft tissue/organ-associated plasmacytomas with no contact to bony structures as per International Myeloma Working Group (IMWG) criteria.2 RedirecTT-1 is the largest study dedicated to patients with EMD to date.1 These data were featured in a late-breaking oral presentation (Abstract #LB4001) at the 2025 European Hematology Association (EHA) Congress.1 EMD represents an aggressive form of multiple myeloma and occurs when myeloma cells spread and form tumours (plasmacytomas) elsewhere in the body, such as in soft tissues and organs.3 These patients often face limited treatment options and worse outcomes due to the complexity of the disease, including tumour heterogeneity, resulting in low ORRs and rapid relapses with current standard therapies.2,3 On average, TCE RRMM patients with EMD have an ORR of less than 40 percent and a median progression-free survival (PFS) of less than six months.4 'The investigational combination of talquetamab and teclistamab has demonstrated deep, durable responses in patients with relapsed or refractory multiple myeloma, and now shows great promise in those with extramedullary myeloma, where standard therapies often fall short,' said Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.* 'Dual targeting of GPRC5D and BCMA may lead to a higher ORR and greater depth of response by mitigating target antigen-related escape. The RedirecTT-1 trial shows the power of this novel dual-targeting combination approach as a potential treatment option for patients with this disease.' The Phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM with true EMD.1 Of these patients, 84.4 percent were triple-class refractory, 35.6 percent were penta-drug refractory, 20.0 percent had previously received BCMA CAR-T therapy, and 8.9 percent had previously received a bispecific antibody.1 The investigational combination of talquetamab and teclistamab led to a high ORR of 78.9 percent (95 percent confidence interval [CI]; 69.0–86.8), with more than half of patients (54.4 percent) achieving complete response or better.1 High responses were observed even in patients exposed to prior BCMA CAR-T or anti-FcRH5 bispecific antibodies (83.3 percent ORR; 58.6-96.4 and 75.0 percent ORR; 34.9-96.8, respectively).1 Among responders, 66.2 percent remained in response at the data cutoff, with a median follow-up of 13.4 months, signalling deep and durable responses.1 Treatment with the combination resulted in 61.0 percent of patients progression-free and alive at one year.1 Additionally, the combination led to durable responses, with 64.1 percent of patients maintaining response (median duration of response: 13.8 months) and 74.5 percent of patients alive at one year, while median overall survival was not yet reached.1 'Multiple myeloma remains a complex and heterogeneous disease, with extramedullary disease presenting a particularly aggressive and challenging to treat form,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology at Johnson & Johnson Innovative Medicine. 'The RedirecTT-1 study reflects our strategy to harness novel mechanisms of action, such as the combination of these dual bispecific antibodies, to help redefine potential outcomes for subsets of patients who are currently faced with a poor prognosis and limited options.' The safety profile of the combination was consistent with previous reports of talquetamab and teclistamab as monotherapies, with no new safety signals identified.1 Patients were given the option to switch to once a month dosing potentially contributing to improved tolerability.1 Rates of discontinuation were low with the treatment combination of talquetamab and teclistamab due to adverse events (AEs).1 Four participants discontinued talquetamab only.1 Reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were mostly low grade.1 Of the ten patients who had Grade 5 AEs (11.1 percent), five were due to infections.1 There were five patient deaths due to infection and the rates of severe infection were similar to those observed with some BCMA bispecific antibody monotherapies.1 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options,' said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our first-in-class bispecific antibodies talquetamab and teclistamab have transformed treatment for relapsed or refractory multiple myeloma. The RedirecTT-1 study underscores our commitment to advancing innovative therapies that attack the disease in different ways by building combinable and complementary regimens.' About Talquetamab Talquetamab received conditional marketing authorisation (CMA) from the European Commission (EC) in August 2023, as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.5 The U.S. Food and Drug Administration (FDA) also granted talquetamab approval in August 2023, for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.6 Talquetamab is a bispecific T-cell engaging antibody that binds to CD3 on the surface of T-cells, and GPRC5D, a novel target which is highly expressed on the surface of multiple myeloma cells, with minimal to no expression detected on B-cells or B-cell precursors.5 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using talquetamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, talquetamab is subject to additional monitoring. About Teclistamab Teclistamab received EC approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.7 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.8 Teclistamab received approval from the U.S. FDA in October 2022 for the treatment of adult patients with RRMM who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.9 Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.9,10 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body's immune system to fight the cancer. Teclistamab is currently being evaluated in several combination studies.10,11,12,13,14 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics. In line with European Medicine Agency (EMA) regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring. About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.15,16 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.15,16 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.17 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy18,19 while remissions become progressively shorter.18,19,20 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.21 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of teclistamab and talquetamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. * Yael Cohen, M.D., Head of Myeloma Unit, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel., has provided consulting, advisory and speaking services to Janssen-Cilag International NV; she has not been paid for any media work. ### 1 Kumar S, et al. Phase 2 study of Talquetamab + Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma with Extramedullary Disease: presentation at 2025 European Hematology Association (EHA) Congress; June 12-15, 2025. 2 Ho M, et Multiple Myeloma: Challenges and Opportunities. Curr. Oncol, 2025; 32: 182. 3 Blade J, et al. Extramedullary Disease in Multiple Myeloma: a Systematic Literature Review. Blood Cancer J, 2022; 12(3):45. 4 Moreau P, et al. Outcomes of Patients With Extramedullary Disease in Triple-Class Exposed Relapsed/Refractory Multiple Myeloma From the Pooled LocoMMotion and MoMMent Studies. Clinical Lymphoma, Myeloma and Leukemia, 2025; 25: S2152-2650. 5 European Medicines Agency. TALVEY Summary of Product Characteristics. Available at: Last accessed: June 2025. 6 FDA. FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025. 7 Janssen Marks First Approval Worldwide. Available at: Last accessed: June 2025. 8 European Commission Approves Reduced Dosing Frequency for Janssen's Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: Last accessed: June 2025. 9 U.S. FDA Approves TECVAYLI™ (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025. 10 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: Last accessed: June 2025. 11 A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: Last accessed: June 2025. 12 A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: Last accessed: June 2025. 13 A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: Last accessed: June 2025. 14 A Study of Teclistamab in Combination With Daratumumab Subcutaneously (SC) (TecDara) Versus Daratumumab SC, Pomalidomide, and Dexamethasone (DPd) or Daratumumab SC, Bortezomib, and Dexamethasone (DVd) in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-3). Available at: Last accessed: June 2025. 15 Abdi J, et al. Drug Resistance in Multiple Myeloma: Latest Findings on Molecular Mechanisms. Oncotarget 2013;4(12):2186-2207. 16 American Society of Clinical Oncology. Multiple Myeloma: Introduction. Available at: Last accessed: June 2025. 17 ECIS – European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: Last accessed: June 2025. 18 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347. 19 Hernández-Rivas JÁ, et al. The Changing Landscape of Relapsed and/or Refractory Multiple Myeloma (MM): Fundamentals and Controversies. Biomark Res. 2022;10(1):1-23. 20 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430. 21 American Cancer Society. Multiple Myeloma: Early Detection, Diagnosis and Staging. Available at: Last accessed: June 2025. CP-526056 June 2025 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
Business Upturn
12-06-2025
- Business
- Business Upturn
Significant efficacy benefit of IMBRUVICA® (ibrutinib) plus venetoclax versus acalabrutinib plus venetoclax in frontline treatment of patients with chronic lymphocytic leukaemia suggested by indirect treatment comparison
Cross-study findings indicate significant clinical benefit of frontline fixed-duration ibrutinib plus venetoclax with improved likelihood of undetectable minimal residual disease and progression-free survival versus acalabrutinib plus venetoclax 1 Phase 2 CAPTIVATE long-term follow-up data further supports sustained efficacy and safety profile of fixed-duration ibrutinib plus venetoclax treatment in patients receiving frontline treatment for chronic lymphocytic leukaemia 2 Beerse, Belgium, June 12, 2025 (GLOBE NEWSWIRE) — Janssen-Cilag International NV, a Johnson & Johnson company, today announced new data from a matching-adjusted indirect comparison (MAIC) analysis assessing the efficacy of IMBRUVICA® (ibrutinib) in combination with venetoclax (I+V) vs acalabrutinib in combination with venetoclax (A+V) as fixed-duration (FD) treatments for adults with previously untreated chronic lymphocytic leukaemia (CLL).1 The data were featured in a poster presentation at the 30th European Hematology Association (EHA) Congress (Poster presentation #PF587) and reported that the I+V regimen yielded significantly better efficacy when compared to the A+V regimen.1 Patients treated with I+V were more likely to achieve disease clearance, as measured by undetectable minimal residual disease (uMRD) three months after the end of treatment (EOT+3), from both peripheral blood (PB) and bone marrow (BM).1 In addition to this, progression-free survival (PFS) significantly favoured I+V compared to A+V.1 'In the absence of head-to-head trials, clinicians need reliable tools to effectively compare treatment options and make the best possible choices for their patients,' said Talha Munir, M.D., Consultant in Clinical Haematology at St James's Hospital, Leeds, United Kingdom.* 'The matching-adjusted indirect comparison data presented at EHA suggests that ibrutinib plus venetoclax may offer meaningful clinical advantages over acalabrutinib plus venetoclax with patients more likely to achieve higher rates of undetectable minimal residual disease, three months after treatment. This may translate into more time in remission and longer progression-free survival – outcomes that matter deeply to both patients and the healthcare professionals who treat them.' Patients who met the AMPLIFY inclusion criteria from both the Phase 3 GLOW (NCT03462719) and Phase 2 CAPTIVATE (NCT02910583) studies were included in this analysis, and, after matching and balancing the treatment cohorts, comparative analyses between the trials suggested that I+V significantly reduced the risk of progression or death by 47 percent when compared to patients treated with A+V (hazard ratio [HR]: 0.53; 95 percent confidence interval [CI]: 0.33-0.85; p =0.0085).1,3,4,5 The results also suggested that patients treated with I+V were almost twice (95 percent CI: 1.47-2.41; p <0.0001) and 2.4 times (95 percent CI: 1.78-3.12; p <0.0001) more likely to achieve uMRD than A+V at EOT+3, in PB and BM, respectively.1 The GLOW and CAPTIVATE FD cohorts were based on individual patient-level data with a median follow-up of approximately 4.5 years, while the A+V cohort used aggregate level data from the AMPLIFY study with a median follow-up of approximately 3.4 years.1 Results from final analysis of CAPTIVATE Long-term follow-up results from the Phase 2 CAPTIVATE study data were presented as a poster at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting (Poster presentation #219) and will also be presented as an encore oral presentation at EHA 2025 (Oral presentation #S156).6 The data reinforced the durable clinical benefit of frontline I+V.2 Phase 2 CAPTIVATE results demonstrated patients in the I+V FD cohort displayed a clinically meaningful PFS and overall survival (OS) vs the MRD-guided cohort.2 After a median follow-up of 68.9 months, the 5.5-year PFS and OS rates for all treated patients were 66 percent (95 percent CI: 58-72) and 97 percent (95 percent CI: 93-99), respectively.2 Additionally, the 5.5 year PFS rate in patients who achieved uMRD in the PB at the EOT was 71 percent (95 percent CI: 60-80).2 Furthermore, 1-year PFS and OS rates from the start of retreatment (with single-agent ibrutinib or FD I+V) were both 100 percent, whilst 2-year PFS and OS rates from the start of retreatment were 91 percent and 96 percent, respectively.2 No new safety signals were observed during the CAPTIVATE study since the previous follow-up, with COVID-19, diarrhoea and hypertension being the most frequently reported adverse events (AEs).2 In the total pooled CAPTIVATE population, 32 percent (n=64/202) of patients had progressive disease following 5.5 years of follow-up.2 Of the 53 patients with available samples, none had acquired resistance-associated mutations in BTK or PLCG2 .2 'The final analysis of CAPTIVATE highlights how ibrutinib continues to raise the bar in the treatment of chronic lymphocytic leukaemia, with durable minimal residual disease response, extended treatment-free intervals, and a tolerable safety profile,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'With the longest follow-up of any oral fixed-dose regimen, ibrutinib is setting a new standard for what patients and clinicians can expect from targeted therapies. We remain committed to advancing science in complex blood cancers and improving outcomes across the cancer care landscape.' 'The updates presented at EHA add to the growing body of evidence in support of ibrutinib, the most extensively studied Bruton's tyrosine kinase inhibitor, as the standard of care in the frontline treatment of chronic lymphocytic leukaemia,' said Jessica Vermeulen, Vice President, Lymphoma & Leukemia Disease Area Stronghold Leader, Johnson & Johnson Innovative Medicine. 'Offering patients not only more time, but also the option for treatment-free remissions continues to be our goal and we are proud of the incredible contribution ibrutinib has made since its first European approval in 2014.' About the MAIC analysis The objective of this analysis was to compare the progression-free survival (PFS) and undetectable minimal residual disease (uMRD) data from the fixed-duration (FD) ibrutinib + venetoclax (I+V) cohorts from the Phase 3 GLOW (NCT03462719) and Phase 2 CAPTIVATE (NCT02910583) studies against the Phase 3 AMPLIFY (NCT03836261) data.1 In absence of prospective head-to-head trials investigating different Bruton's tyrosine kinase inhibitors (BTKis) plus B-cell lymphoma 2 (Bcl-2) strategies, this study utilised matching-adjusted indirect comparison (MAIC) to obtain useful insights on comparative efficacy.1 Individual patient data from the FD I+V cohorts of the GLOW and CAPTIVATE studies were pooled and compared to aggregate published Intent-to-Treat (ITT) data of the acalabrutinib plus venetoclax (A+V) arm of the AMPLIFY study.1,3,4,5 A MAIC was performed following method published by Signorovitch et al. and guidelines from the National Institute for Health and Care Excellence (NICE).1,7 Patients who did not meet the inclusion criteria of AMPLIFY were excluded from the I+V pooled cohort to establish the I+V patient population for analysis.1 The remaining I+V patients were then reweighted so that the average baseline characteristics of the pooled I+V cohort matched those of the A+V patients in AMPLIFY.1 The reweighted outcomes from I+V were then compared to the reported outcomes for A+V using indirect treatment comparison.1 Relative effects were quantified using relative risk (RR) and hazard ratios (HR) with 95 percent confidence intervals.1 There are potential sources of bias that cannot be accounted for in MAIC, that should be considered when interpreting such data. Specifically, in this comparison, the measurement of progression was stricter in GLOW and CAPTIVATE, requiring computer or magnetic imaging regardless of suspected progression and the median follow-up was longer in I+V population.1 Both may have biased the PFS results in favour of A+V.1 Additionally, AMPLIFY reported multicolour flow cytometry use but with no details on the number of colours and comparability is assumed with the 8-colour assay used in I+V studies.1 As in any non-randomised comparison there may be additional unreported clinically important prognostic patient baseline characteristics which cannot be accounted for.1 For example, Cumulative Illness Rating Scale score data was not collected in CAPTIVATE and therefore could not be used in matching.1 About CAPTIVATE The Phase 2 CAPTIVATE study ( NCT02910583 ) evaluated previously untreated adult patients with chronic lymphocytic leukaemia (CLL), who were 70 years or younger, including patients with high-risk disease, in two cohorts with combined median age of 60 years: a minimal residual disease (MRD)-guided cohort (n=43) and an FD cohort (n=159; median age).2,4,8 Patients in the FD cohort received three cycles of ibrutinib lead-in followed by 12 cycles of I+V (oral ibrutinib [420 mg/d]; oral venetoclax [five-week ramp-up to 400 mg/d]) and the primary endpoint was complete response rate.4 In the MRD cohort, after completion of three cycles ibrutinib lead-in followed by 12 cycles I+V, patients with confirmed uMRD were randomly assigned to double-blind treatment with placebo, or continuous ibrutinib.4 The primary endpoint was one-year disease-free survival.4 About the GLOW study The GLOW study ( NCT03462719 ) is a randomised, open-label, Phase 3 trial that evaluated the efficacy and safety of frontline, FD I+V versus chlorambucil plus obinutuzumab in adult patients with CLL who are (a) ≥65 years old, or (b) 18-64 years old with a Cumulative Illness Rating Scale score of greater than six or creatinine clearance less than 70 mL/min, who had active disease requiring treatment per the International Workshop on CLL criteria.3 About ibrutinib Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.9 Ibrutinib blocks the Bruton's tyrosine kinase (BTK) protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.10 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation.11 Ibrutinib is approved in more than 100 countries and has been used to treat more than 325,000 patients worldwide.12 There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.10,13 In October 2021, ibrutinib was added to the World Health Organization's Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.14 Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:10 As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated CLL As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy As a single agent for the treatment of adult patients with relapsed or refractory (RR) mantle cell lymphoma (MCL) As a single agent for the treatment of adult patients with Waldenström's macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics . About Chronic Lymphocytic Leukaemia CLL is typically a slow-growing blood cancer of the white blood cells.15 The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and it is about 1.5 times more common in men than in women (based on individuals diagnosed 2000-2002).16 CLL is predominantly a disease of the elderly, with a median age of 72 years at diagnosis.17 While patient outcomes have dramatically improved in the last few decades, the disease is still characterised by consecutive episodes of disease progression and the need for therapy.18 Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.19 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at . Follow us at . Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Talha Munir, M.D., Consultant in Clinical Haematology at St James's Hospital, Leeds, United Kingdom, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. 1 Munir T, et al., Cross-Study Comparison of Ibrutinib in Combination with Venetoclax (I+V) vs Acalabrutinib in Combination with Venetoclax (A+V) in Subjects with Previously Untreated Chronic Lymphocytic Leukemia (CLL). Poster presentation at 2025 European Hematology Association (EHA) Congress; June 12–15, 2025. [Poster PF587]. 2 Ghia P, et al. Final Analysis of Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) in the Phase 2 CAPTIVATE Study. Oral presentation at 2025 European Hematology Association (EHA) Congress; June 12–15, 2025. [Oral S156]. 3 A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (GLOW). Available at: Last accessed: June 2025. 4 Ibrutinib Plus Venetoclax in Subjects With Treatment-naive Chronic Lymphocytic Leukemia /Small Lymphocytic Lymphoma (CLL/SLL) (CAPTIVATE). Available at: Last accessed: June 2025. 5 Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL (AMPLIFY). Available at: Last accessed: June 2025. 6 Ghia P, et al. Final Analysis of Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Phase 2 CAPTIVATE Study. Poster presentation at 2025 American Society of Clinical Oncology (ASCO) Annual Meeting; May 30–June 3, 2025. [Poster #219]. 7 Signorovitch JE, et al. Matching-adjusted Indirect Comparisons: A New Tool for Timely Comparative Effectiveness Research. Value Health, 2012; 15: 940-947. 8 Jacobs R, et al., Outcomes in High-risk Subgroups After Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma: Up To 5.5 years of Follow-up in the Phase 2 CAPTIVATE Study. Poster presentation at 2024 European Hematology Association (EHA) Hybrid Congress; June 13–16, 2024. [Poster P675]. 9 European Medicines Agency. IMBRUVICA Summary of Product Characteristics. April 2025. Available at: Last accessed: June 2025. 10 Turetsky A, et al. Single cell Imaging of Bruton's tyrosine kinase using an Irreversible Inhibitor. Sci Rep. 2014; 4: 4782. 11 de Rooij MF, et al. The Clinically Active BTK Inhibitor PCI-32765 targets B-cell Receptor- and Chemokine-controlled Adhesion and Migration in Chronic Lymphocytic Leukemia. Blood. 2012; 119(11): 2590-2594. 12 J&J Data on File (RF-465355). Patients Treated on Imbruvica Worldwide. May 2025. 13 Pollyea DA, et al. A Phase I Dose Escalation Study of the Btk Inhibitor PCI-32765 in Relapsed and Refractory B Cell Non-Hodgkin Lymphoma and Use of a Novel Fluorescent Probe Pharmacodynamic Assay. Blood. 2009; 114(22): 3713. 14 World Health Organization. WHO Prioritizes Access to Diabetes and Cancer Treatments in New Essential Medicines Lists. Available at: Last accessed: June 2025. 15 American Cancer Society. What is Chronic Lymphocytic Leukemia? Available at: Last accessed: June 2025. 16 Sant M, et al. Incidence of Hematologic Malignancies in Europe by Morphologic Subtype: Results of the HAEMACARE project. Blood. 2010; 116:3724–34. 17 Eichhorst B, et al. Chronic Lymphocytic Leukaemia: ESMO Clinical Practice Guidelines for Diagnosis, Treatment and Follow-up Ann Oncol. 2021; 32(1): 23-33. 18 Moreno C. Standard Treatment Approaches for Relapsed/refractory Chronic Lymphocytic Leukemia after Frontline Chemoimmunotherapy. Hematology Am Soc Hematol Educ Program. 2020; 2020: 33-40. 19 Bewarder M, et al. Current Treatment Options in CLL. Cancers (Basel). 2021;13(10): 2468. CP-523458 June 2025 Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same.
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03-06-2025
- Business
- Yahoo
Single infusion of CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) delivered lasting treatment-free remissions for at least five years in patients with relapsed or refractory multiple myeloma
New long-term CARTITUDE-1 data show one-third of patients treated with cilta-cel remain progression-free at five years1 CARTITUDE-4 analysis shows overall survival and progression-free benefits in standard and high-risk subgroups across prior lines of treatment2 BEERSE, BELGIUM, June 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating 33 percent (n=32) of patients in the study (n=97) with relapsed or refractory multiple myeloma (RRMM) treated with CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) achieved progression-free survival (PFS) of five years or more with a single infusion and no maintenance or subsequent anti-myeloma therapy.1 These data underscore Johnson & Johnson's dedication to advancing transformative therapies that aim to reshape the treatment landscape for patients with multiple myeloma. In a subset of 12 patients who underwent serial evaluations at a single site, all were minimal residual disease (MRD) negative (at least 10–5 threshold) and imaging negative throughout five years of post-treatment follow-up.1 Findings were featured in an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7507). The data were also simultaneously published in The Journal of Clinical Oncology.3 'This new evidence shows how a single infusion of cilta-cel can help patients survive without disease progression much longer than previously thought possible in this setting, and without any maintenance or subsequent treatment,' said Peter M. Vorhees, M.D., Clinical Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine.* 'In a heavily pre-treated population, a third of patients remained treatment- and progression-free for at least five years.' The Phase 1b/2 CARTITUDE-1 study (n=97) evaluated cilta-cel for the treatment of heavily pre-treated patients with RRMM.1 Patients who remained progression-free for at least five years (n=32) had a median of six prior lines of therapy and included subgroups with high-risk cytogenetics (23.3 percent), extramedullary disease (12.5 percent), triple-class refractory disease (90.6 percent), and penta-drug refractory disease (46.9 percent).1 At a median follow-up of 61.3 months, median overall survival (OS) was 60.7 months (95 percent confidence interval [CI], 41.9, not estimable [NE]), highlighting the depth and durability of response with cilta-cel.1 With an additional ~28 months median follow-up, the safety profile in CARTITUDE-1 was consistent with the known safety profile of cilta-cel, with no new safety signals observed.1 There were two newly reported second primary malignancies (both solid tumours), two additional neurologic events, not related to cilta-cel, including one case each of encephalopathy and taste disorder, four new-onset Grade 3 infections (not related to cilta-cel), and no new Parkinsonism events or cranial nerve palsies.1 'The latest results from the CARTITUDE-1 study mark a major milestone in the treatment of relapsed and refractory multiple myeloma, with a single infusion of cilta-cel delivering unprecedented long-term outcomes,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'In a patient population where median overall survival has traditionally been around one year, it is promising to see many people now living beyond five years - a testament to the transformative potential of cilta-cel.' Additional data from another cilta-cel study, CARTITUDE-4, also presented at the 2025 ASCO Annual Meeting, evaluated PFS and OS versus standard of care (SOC) in prespecified subgroups, including patients with standard and high-risk cytogenetics, extramedullary disease, and by line of therapy (Abstract #7539).2 Results demonstrated that cilta-cel improved PFS and OS across subgroups versus SOC. In patients with standard risk-disease after 1 to 3 prior lines of treatment, PFS curves indicate stability in survival rates.2 'Across our multiple myeloma portfolio and pipeline, we are shifting from treating to progression to treating to cure,' said Jordan Schecter, M.D., Vice President, Research & Development, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'Our focus is to extend patient survival, and based on our expertise of the disease biology, develop treatment regimens with curative potential.' Results will also be presented at the upcoming European Hematology Association (EHA) 2025 Congress. About CARTITUDE-1CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicentre study evaluating the efficacy and safety of cilta-cel in adults with relapsed and/or refractory multiple myeloma (RRMM), 99 percent of whom were refractory to the last line of treatment; 88 percent of whom were triple-class refractory, meaning their cancer did not or no longer responds to an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody.4,5 The primary objective of the Phase 1b portion of the study, involving 29 patients, was to characterise the safety and confirm the dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2).4 Based on the safety profile observed in this portion of the study, outpatient dosing is being evaluated in additional CARTITUDE studies. The Phase 2 portion of the study is evaluating the efficacy of cilta-cel with overall response as the primary endpoint.4 The study involved patients with heavily pretreated RRMM who historically have an expected median progression-free survival of <6 months and median overall survival of ~1 year.4 About CARTITUDE-4 CARTITUDE-4 (NCT04181827) is the first international, randomised, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.6 Patients were randomised to receive either a sequence of apheresis, bridging therapy, lymphodepletion and cilta-cel (n=208) or standard of care (SOC), which included PVd or DPd (n=211).7 The primary outcome measure for the study is progression free survival (PFS), defined as the time from the date of randomisation to the date of first documented disease progression, as defined in the International Myeloma Working Group (IMWG) criteria, or death due to any cause.6 Safety, overall survival (OS), minimal residual disease (MRD) negativity rate and overall response rate are secondary endpoints.6 About Cilta-cel Cilta-cel is a B-cell maturation antigen (BCMA)-directed, genetically modified autologous T-cell immunotherapy that involves reprogramming a patient's own T-cells with a transgene encoding chimeric antigen receptor (CAR) that directs the CAR-positive T-cells to eliminate cells that express BCMA.7 BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells.8 The cilta-cel CAR protein features two BCMA-targeting single domains designed to confer high avidity against human BCMA.7 Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.9 In April 2024, the European Commission (EC) approved an indication extension for cilta-cel for the treatment of adults with RRMM who have received at least one prior therapy, including an iMiD and a PI, have demonstrated disease progression on the last therapy, and are refractory to lenalidomide. In April 2024, cilta-cel was approved in the U.S. for the second-line treatment of adult patients with relapsed or refractory myeloma who have received at least one prior line of therapy including a PI, an iMiD, and who are refractory to lenalidomide. In December 2017, Janssen Biotech, Inc., a Johnson & Johnson company, entered into an exclusive worldwide licence and collaboration agreement with Legend Biotech USA, Inc., to develop and commercialise cilta-cel.10 For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using cilta-cel please refer to the Summary of Product Characteristics.7 In line with European Medicines Agency (EMA) regulations for new medicines and those given conditional approval, cilta-cel is subject to additional monitoring.7 About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.11,12 In multiple myeloma, these plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, often causing bone destruction and other serious complications.13 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.14 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy while remissions become progressively shorter.15,16,17 Whilst some people diagnosed with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney problems.18,19 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of cilta-cel. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. * Dr Peter M. Vorhees, M.D., Clinical Professor of Hematology and Oncology at Atrium Health, Levine Cancer Institute at Wake Forest University School of Medicine, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. ### 1 Voorhees, P. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.2 Sidana, S. Ciltacabtagene autoleucel (cilta-cel) vs standard of care (SOC) in patients (pts) with relapsed/refractory multiple myeloma (MM): CARTITUDE-4 survival subgroup analyses. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.3 Voorhees, P. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). J Clin Oncol. 43, 7507-7505. DOI:10.1200/JCO.2025.43.16_suppl.7507 4 A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma (CARTITUDE-1). Available at: Study Details | A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-Cell Maturation Antigen (BCMA) in Participants With Relapsed or Refractory Multiple Myeloma | Last accessed: May 2025.5 Lin Y, et al. CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting 2023.6 A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE4). Available at: Last accessed: May 2025.7 European Medicines Agency. CARVYKTI (ciltacabtagene autoleucel) Summary of Product Characteristics. Available at: Last accessed: May 2025.8 Cho, et al. Targeting B Cell Maturation Antigen (BCMA) in Multiple Myeloma: Potential Uses of BCMA-Based Immunotherapy. Front Immunol 2018;10(9):1821. 9 Tai, et al. Targeting B-cell maturation antigen in multiple myeloma. Immunotherapy 2015;7(11):1187-1199. 10 Janssen Enters Worldwide Collaboration and License Agreement with Chinese Company Legend Biotech to Develop Investigational CAR-T Anti-Cancer Therapy. Available at: Last accessed: May 2025.11 Abdi, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207.12 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: Last accessed: May 2025. 13 City of Hope. Multiple Myeloma: Causes, Symptoms & Treatments. Available at: Last accessed: May 2025. 14 ECIS. European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: Last accessed: May 2025.15 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.16 Hernández-Rivas JÁ, et al. The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies. Biomark Res. 2022;10(1):1-23.17 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.18 American Cancer Society. What is Multiple Myeloma? Last accessed: May 2025.19 American Cancer Society. Multiple Myeloma Early Detection, Diagnosis, and Staging. Last accessed: May 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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03-06-2025
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New analyses reinforce long-term benefit of DARZALEX® (daratumumab) subcutaneous-based quadruplet regimen for patients with newly diagnosed multiple myeloma
Sustained MRD negativity (10-5) rates at 24 months or longer were more than doubled in transplant eligible patients treated with daratumumab-VRd vs VRd alone in the Phase 3 PERSEUS study1 Data from the Phase 3 CEPHEUS study show daratumumab-VRd significantly reduced the risk of progression or death by 49 percent vs VRd alone in transplant-ineligible newly diagnosed patients2 BEERSE, BELGIUM, June 03, 2025 (GLOBE NEWSWIRE) -- Janssen-Cilag International NV, a Johnson & Johnson company, today announced data from two studies highlighting that DARZALEX® (daratumumab) subcutaneous (SC) formulation with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd) demonstrated deep and sustained minimal residual disease (MRD) negativity rates, and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma (NDMM), regardless of transplant status.1,2 Findings were highlighted as oral presentations of an analysis of sustained MRD in transplant-eligible patients from the Phase 3 PERSEUS study (Abstract #7501) and a subgroup analysis of transplant-ineligible patients in the Phase 3 CEPHEUS study (Abstract #7516) at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.1,2 'Daratumumab-based quadruplet regimens are redefining frontline treatment in multiple myeloma, offering the potential for deeper, more durable responses from the start, bringing patients closer to long-term remission,' said Ester in't Groen, EMEA Therapeutic Area Head Haematology, Johnson & Johnson Innovative Medicine. 'The latest data presented at ASCO further support the role of the PERSEUS and CEPHEUS regimens as a standard of care in patients with newly diagnosed disease, regardless of transplant eligibility.' A new analysis from the Phase 3 PERSEUS study shows the addition of daratumumab-VRd followed by a maintenance regimen of daratumumab SC with lenalidomide (daratumumab-R), led to improved and deepened rates of overall and sustained MRD negativity (10-5) compared to VRd induction and consolidation with R maintenance.1 At a median follow-up of 47.5 months, sustained MRD negativity (10-5) rates were more than doubled with daratumumab-VRd followed by daratumumab-R maintenance compared to VRd and R maintenance at both 12 months or longer (64.8 percent vs 29.7 percent; odds ratio, 4.42; 95 percent confidence interval [CI], 3.22–6.08; p<0.0001) and 24 months or longer (55.8 percent vs 22.6 percent; odds ratio [OR], 4.36, 95 percent CI, 3.15–6.05, p<0.0001).1 Among patients achieving sustained MRD negativity for 12 months or longer, the 48-month PFS rate for daratumumab-VRd followed by daratumumab-R maintenance was 95.3 percent compared to 94.2 percent for VRd and R maintenance (hazard ratio [HR], 0.83; 95 percent CI,0.3–2.3)—reinforcing the importance of achieving sustained MRD negativity for prolonged disease remission.1 'The data show that daratumumab-VRd followed by a daratumumab-R maintenance regimen is a highly effective treatment option for transplant-eligible patients with newly diagnosed multiple myeloma,' said Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France and presenting author.* 'The depth and durability of MRD negativity observed—paired with high rates of progression-free survival at four years—underscore the long-term benefit the daratumumab SC-based regimen can offer patients early in their treatment journey.' Additional data from Phase 3 CEPHEUS study explore the benefits of daratumumab SC in transplant-ineligible patients across cytogenetic risk status The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, reinforcing that adding daratumumab SC to VRd significantly deepens response and prolongs PFS compared to VRd alone in this patient population.2 At a median follow-up of 58.7 months, patients receiving daratumumab-VRd achieved markedly higher overall MRD negativity rates at the 10⁻⁵ sensitivity threshold with 60.4 percent vs 39.3 percent with VRd (OR, 2.37; 95 percent CI, 1.47–3.80; p=0.0004).2 Furthermore, treatment with daratumumab-VRd resulted in high MRD-negativity rates at the 10⁻⁶ threshold with 45.8 percent compared to 26.9 percent with VRd (OR, 2.28; 95 percent CI, 1.40–3.73; p=0.0010).2 These deeper responses translated into improved long-term outcomes, with 69.0 percent of patients remaining progression-free at 54-months when treated with daratumumab-VRd vs 48.0 percent with VRd (HR, 0.51; 95 percent CI, 0.35–0.74; p=0.0003).2 Overall survival (OS) numerically favoured daratumumab-VRd (HR, 0.66; 95 percent CI, 0.42–1.03, p=0.0682), with an even greater benefit observed after censoring for COVID-19-related deaths (HR, 0.55; 95 percent CI, 0.34–0.90, p=0.0159).2 Additional data presented at ASCO included a subgroup analysis of the CEPHEUS trial for both transplant-ineligible and deferred NDMM patients who were considered high-risk for cytogenetic abnormalities (Abstract #7529).3 At a median follow-up of 58.7 months, overall MRD negativity rate was improved for patients with standard risk in daratumumab-VRd vs VRd.3 Although rates of MRD negativity by treatment arm in patients with protocol-defined high-risk were comparable, PFS trended toward improvement with daratumumab-VRd.3 'Across multiple studies, the growing body of data on daratumumab-based regimens indicates impressive, deep responses and meaningful progression-free survival in patients with newly diagnosed multiple myeloma, including high-risk,' Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Johnson & Johnson Innovative Medicine. 'These consistent results across patient populations, regardless of transplant eligibility, reinforce the role of daratumumab SC as a cornerstone of frontline therapy.' In the PERSEUS and CEPHEUS studies, the safety profiles were consistent with the known safety profile for daratumumab SC.1,2,3 Safety results of daratumumab-VRd in the PERSEUS study were previously reported in The New England Journal of Medicine.4 The most common haematologic adverse reactions (≥20 percent) in patients with multiple myeloma who received daratumumab-VRd vs VRd included neutropenia (69.2 percent vs 58.8 percent), thrombocytopenia (48.4 percent vs 34.3 percent), and anaemia (22.2 percent vs 20.7 percent).4 Similarly, in the CEPHEUS study, daratumumab-VRd showed no additional safety concerns in the transplant-ineligible subgroup compared with the intent to treat population.2 The most common Grade 3/4 haematologic treatment-emergent adverse events (TEAEs) were neutropenia (43.8 percent vs 31.7 percent), thrombocytopenia (30.6 percent vs 23.2 percent) and anaemia (12.5 percent vs 12.7 percent).2 About the PERSEUS and CEPHEUS studiesThe PERSEUS study (NCT03710603) is being conducted in collaboration with the European Myeloma Network as the sponsor.5 PERSEUS is an ongoing, randomised, open-label, Phase 3 study comparing the efficacy and safety of daratumumab, bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) and autologous stem cell transplant (ASCT) followed by D-R maintenance vs standard bortezomib, lenalidomide, and dexamethasone (VRd) and ASCT followed by R maintenance in patients with transplant eligible newly diagnosed multiple myeloma (NDMM) (n=355).4 The primary endpoint is progression-free survival (PFS), and secondary endpoints include overall complete response or better rate, overall minimal residual disease (MRD) negativity (in patients with complete response or better) and overall survival (OS).4 Daratumumab subcutaneous (SC) formulation was discontinued after at least 24 months of D-R maintenance therapy in patients who had a complete response or better and had sustained MRD negative status for at least 12 months.4 The median age is 61.0 (range, 32-70) years for patients in the daratumumab-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm.4 The study is being conducted in 13 countries in Europe and Australia.5 On 23 October 2024, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM who are eligible for ASCT, based on the results of the PERSEUS study.6,7 CEPHEUS (NCT03652064) is an ongoing, randomised, open-label, Phase 3 study comparing SC daratumumab-VRd with standard VRd.8,9 The trial has enrolled 395 patients with NDMM who are either ineligible for stem cell transplantation (SCT) or for whom SCT is not planned.9 The primary endpoint is overall MRD-negativity rate.9 The minimum age for participation is 18 years for patients in both the daratumumab-VRd arm and VRd arm, with a median patient age of 70 (range 31-80).8 The study is being conducted in 13 countries across North America, South America and Europe.9 On 7 April 2025, an indication extension for daratumumab-VRd was approved by the European Commission for NDMM, based on the results of the CEPHEUS study.9,10 About daratumumab and daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 618,000 patients worldwide.11 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.12 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme's ENHANZE® drug delivery technology.12 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.12 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.12 Daratumumab may also have an effect on normal cells.12 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.8,13,14,15,16,17,18,19,20 For further information on daratumumab, please see the Summary of Product Characteristics at: About Multiple MyelomaMultiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.21,22 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.22 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died.23 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy 24,25 while remissions become progressively shorter.24,25,26 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.27 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow. and profoundly impact health for humanity. Learn more at Follow us at Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of daratumumab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's most recent Annual Report on Form 10-K, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Philippe Moreau, M.D., head of the Hematology Department, University Hospital Hôtel-Dieu, Nantes, France, has provided consulting, advisory, and speaking services to Janssen-Cilag International NV; he has not been paid for any media work. 1 Moreau P, et al. Subcutaneous daratumumab (Dara) + bortezomib/lenalidomide/dexamethasone (VRd) with Dara + lenalidomide (DR) maintenance in transplant-eligible (TE) patients with newly diagnosed multiple myeloma (NDMM): analysis of sustained minimal residual disease negativity in the phase 3 PERSEUS trial. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.2 Facon T, et al. Daratumumab plus bortezomib, lenalidomide, and dexamethasone (DVRd) in patients with newly diagnosed multiple myeloma (NDMM): Subgroup analysis of transplant-ineligible (TIE) patients in the phase 3 CEPHEUS study. Oral presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.3 Bahlis N.J, Daratumumab + bortezomib, lenalidomide, and dexamethasone (DVRd) vs VRd in transplant-ineligible (TIE)/transplant-deferred (TD) newly diagnosed multiple myeloma (NDMM): phase 3 CEPHEUS trial cytogenetic subgroup analysis. Poster presentation. American Society of Clinical Oncology (ASCO) Annual Meeting; May 30 – June 3, 2025.4 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024; 390:301-313.5 Daratumumab, VELCADE (bortezomib), lenalidomide and dexamethasone compared to VELCADE, lenalidomide and dexamethasone in subjects with previously untreated multiple myeloma (Perseus). NCT03710603. Available at: Last accessed: May 2025.6 Rodríguez-Otero P, et al. Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): analysis of minimal residual disease (MRD) in the PERSEUS trial. 2024 American Society for Clinical Oncology (ASCO) Annual Meeting. June 3, 2024.7 Johnson & Johnson Innovative Medicine EMEA. DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Available at: Last accessed: May 2025.8 Usmani S Z, et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral presentation. 21st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024.9 A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy. NCT03652064. Available at: Last accessed: May 2025.10 European Commission approves Johnson & Johnson's subcutaneous DARZALEX® (daratumumab)-based quadruplet regimen for the treatment of patients with newly diagnosed multiple myeloma, regardless of transplant eligibility. Available at: Last accessed: May 2025.11 Johnson & Johnson [data on file]. RF-430506. Number of patients treated with DARZALEX® worldwide as of 30 June 2024.12 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: Last accessed: May 2025.13 Moreau P, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, openlabel, phase 3 study. Lancet 2019;394(10192):29-38.14 Facon T, et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115.15 Mateos MV, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:P132-141.16 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812.17 Palladini G, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80.18 Chari A, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981.19 Bahlis NJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884.20 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518.21 Abdi J, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207.22 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: Last accessed: May 2025.23 ECIS - European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: Last accessed: May 2025.24 Bhatt P, Kloock C, Comenzo R. Relapsed/Refractory Multiple Myeloma: A Review of Available Therapies and Clinical Scenarios Encountered in Myeloma Relapse. Curr Oncol. 2023;30(2):2322-2347.25 Hernández-Rivas JÁ, et al. The changing landscape of relapsed and/or refractory multiple myeloma (MM): fundamentals and controversies. Biomark Res. 2022;10(1):1-23.26 Gavriatopoulou M, et al. Metabolic Disorders in Multiple Myeloma. Int J Mol Sci. 2021;22(21):11430.27 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: Last accessed: May 2025. CP-520659 May 2025 CONTACT: Media contact: Jenni Mildon jmildon@ +44 7920 418 552 Investor contact: Lauren Johnson investor-relations@
