
Investigational combination of first-in-class bispecific antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) shows deep and durable responses in heavily pretreated multiple myeloma patients
Data signal potential of novel, off-the-shelf approach in patients with extramedullary disease who face significant unmet needs1
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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 www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea. 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 http://www.sec.gov, http://www.jnj.com, 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.
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1 Kumar S, et al. Phase 2 study of Talquetamab + Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma with Extramedullary Disease: RedirecTT-1.Oral presentation at 2025 European Hematology Association (EHA) Congress; June 12-15, 2025.
2 Ho M, et al.Extramedullary 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: https://www.ema.europa.eu/en/documents/product-information/talvey-epar-product-information_en.pdf. Last accessed: June 2025.
6 FDA. FDA Grants Accelerated Approval to Talquetamab-tgvs for Relapsed or Refractory Multiple Myeloma. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma. Last accessed: June 2025.
7 Janssen.com. Janssen Marks First Approval Worldwide. Available at: https://www.janssen.com/emea/sites/www_janssen_com_emea/files/teclistamab_ec_approval_release.pdf. Last accessed: June 2025.
8 Janssen.com. European Commission Approves Reduced Dosing Frequency for Janssen's Bispecific Antibody TECVAYLI®▼ (teclistamab). Available at: https://www.jnj.com/media-center/press-releases/european-commission-approves-reduced-dosing-frequency-for-janssens-bispecific-antibody-tecvayli-teclistamab. Last accessed: June 2025.
9 Janssen.com. 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: https://www.jnj.com/media-center/press-releases/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. Last accessed: June 2025.
10 European Medicines Agency. TECVAYLI Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/tecvayli-epar-product-information_en.pdf. Last accessed: June 2025.
11 ClinicalTrials.gov. A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple Myeloma (MajesTEC-2). Available at: https://clinicaltrials.gov/ct2/show/NCT04722146. Last accessed: June 2025.
12 ClinicalTrials.gov. A Study of the Combination of Talquetamab and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04586426. Last accessed: June 2025.
13 ClinicalTrials.gov. A Study of Subcutaneous Daratumumab Regimens in Combination With Bispecific T Cell Redirection Antibodies for the Treatment of Participants With Multiple Myeloma. Available at: https://clinicaltrials.gov/ct2/show/NCT04108195. Last accessed: June 2025.
14 ClinicalTrials.gov. 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: https://clinicaltrials.gov/ct2/show/NCT05083169. 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: https://www.cancer.org/cancer/types/multiple-myeloma/if-you-have-multiple-myeloma. Last accessed: June 2025.
17 ECIS – European Cancer Information System. Estimates of Cancer Incidence and Mortality in 2022, by Country. Multiple Myeloma. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27. 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: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Last accessed: June 2025.
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Multiple factors today are aiding the growth of the electric vehicle e-axle market. Rising EV adoption for a cleaner and sustainable environment is one of the major factors for the growth of the market. Automobile consumers today are highly inclined towards EV purchasing compared to ICEs. Better performance, fuel cost-saving, and sustainability are the factors allowing the growth of EV adoption, further helping the growth of the market. To promote sustainability at a higher pace, the government provides subsidies and grants to consumers and companies to purchase EVs. Challenge High Manufacturing Cost of E-Axles and EVs Restraining the Market Growth High costs involved in the manufacturing of EVs and e-axles are one of the major restraints of the electric vehicle e-axle market. The introduction of new technologies in the EV segment for improved powertrain and improved vehicle performance is also a high-cost procedure. Such situations can also block the electric vehicle e-axle market growth. Shortage of raw materials for the manufacturing of electric vehicle e-axles is another aspect restraining the growth of the market. Hence, such obstructions may disturb the market's growth. Opportunity Advancements in Integrated Systems Providing Opportunity for Market's Growth Improved integrated system of EVs is helping the growth of the electric vehicle e-axle market in the foreseeable period. It helps in enhancing efficiency, better performance, improved battery performance, and cost-effectiveness as well. Such factors also help in improving the range of EVs, further fuelling the growth of the segment and the market. Such advancements also help in following the proper timeline for manufacturing procedure, lowering unnecessary costs, and accelerating time-to-time Analysis By Vehicle Type The Passenger Car Segment Dominated the Electric Vehicle E-Axle Market The passenger car segment of the electric vehicle e-axle market led the market due to the high adoption of EVs in the recent period. Automobile consumers today prefer EVs on a higher scale due to their sustainability factor, which helps save fuel costs. EVs are also efficient and help in cost savings, helping consumers to opt for EV passenger cars. Governments globally also provide subsidies, tax benefits, and lower registration fees to enhance the growth of the electric vehicle e-axle market. Compact designs and improved efficiency due to e-axles also help to enhance the sales of EVs. The commercial vehicle segment of the electric vehicle e-axle market is observing a significant growth in the foreseeable period. The use of heavy vehicles for transportation plays a huge role for companies. Hence, the adoption of commercial EVs helps companies to control their carbon emissions, as the government has laid strict rules for the same. Commercial EVs perform better and have lightweight e-axles, further fuelling the growth of the segment and market. Hence, companies prefer to use EVs for enhanced last-mile deliveries and maintain the zero-emission mission as well. By Drive Type The Front-Wheel Drive Segment led the Electric Vehicle E-Axle Market The front-wheel drive segment helped the growth of the electric vehicle e-axle market due to its cost-effectiveness and higher adoption globally. Better performance, energy efficiency, and their lightweight helped the segment lead the market. E-axle's integration in EVs helps to improve powertrain architecture, motor performance, reduce vehicle weight, and lower manufacturing cost, fuelling the growth of the electric vehicle e-axle market. It makes it more accessible for consumers to buy EVs. The rear-wheel drive segment of the electric vehicle e-axle market is expected to grow notably in the forecast period, as it is a crucial part of the market. The rear-wheel integration system, consisting of an electric motor, gearbox, and a rear axle in a single unit, helps in the easy movement of an EV. It also helps in enhanced handling and managing traction in sporty and performance-based models. Hence, the segment is observed with a notable growth in the forecast period. More Insights of Towards Automotive: Automotive Axle Market - The global automotive axle market size is calculated at USD 8.6 billion in 2024 and is expected to be worth USD 26.92 billion by 2034, expanding at a CAGR of 12.15% from 2024 to 2034. E-SUVs Market Strategic Market - The E-SUVs market is forecast to grow from USD 337.42 billion in 2025 to USD 13,969.03 billion by 2034, driven by a CAGR of 51.24% from 2025 to 2034. 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Smart EV Charger Market - The smart EV charger market size is expected to grow from USD 45.91 billion in 2025 to USD 208.35 billion by 2034, with a CAGR of 18.3% throughout the forecast period from 2025 to 2034. Electric Vehicle (EV) Charger Market - The electric vehicle (EV) charger market size is forecasted to expand from USD 18.94 billion in 2025 to USD 175.16 billion by 2034. Portable EV Charger Market - The portable EV charger market size is projected to reach USD 1315.87 million by 2034, growing from USD 225.7 million in 2025, at a CAGR of 21.64%. Regional Analysis Asia Pacific Dominated the Electric Vehicle E-Axle Market Asia Pacific dominated the electric vehicle e-axle market due to various reasons contributing to the growth of the market. Higher adoption of EVs in the region to maintain sustainability is a major growth factor for the market. The government providing subsidies, tax benefits, and offering lower registration fees for higher EV adoption is also helping the market's growth in the region. E-axles are lightweight and also help to improve the performance of the EV, further fueling the growth of the market. Well-established EV manufacturing base in India and China is further helping the market's growth in the region. North America is expected to grow with a notable CAGR in the forecast period. North America is expected to grow notably in the forecast period due to various factors helping the growth of the market. Higher adoption of EVs in the region is the primary reason for the market's growth. Government subsidies and tax benefits are another major factor helping the growth of the electric vehicle e-axle market in North America. Developing EV infrastructure and a rising number of EV charging stations are also supporting the growth of the market. North America's strong manufacturing base of EVs in the U.S and Canada plays a pivotal role in the growth of the market in the Developments in Electric Vehicle E-Axle Market In June 2025, American Axle & Manufacturing received a supply order for Scout Motors' front electric drive units (EDUs) and rear e-Beam axles. The company revealed the information in its statement. In November 2024, Renesas Electronics Corp., in collaboration with Nidec Corp., launched the world's first '8-in-1' proof of concept (PoC) for E-Axle systems for electric vehicles (EVs). The system can control 8 functions with a single microcontroller. Top Companies of Electric Vehicle E-Axle Market Dana Limited (U.S.) Robert Bosch GmbH (Germany) GKN Automotive Limited (U.K.) Nidec Corporation (Japan) ZF Friedrichshafen AG (Germany) Vitesco Technologies Group AG (Germany) Schaeffler AG (Germany) Linamar Corporation (Canada) Magna International Inc. (Canada) Suzhou Inovance Automotive Co., Ltd. (China) Segments Covered in the Report By Vehicle Type Passenger Car Commercial Vehicle By Drive Type All-Wheel Drive Front-Wheel Drive Rear-Wheel Drive By Region North America Latin America Europe Asia Pacific Middle East and Africa Invest in Premium Global Insights @ You can place an order or ask any questions, please feel free to contact us at sales@ About Us Towards Automotive is a premier research firm specializing in the automotive industry. Our experienced team provides comprehensive reports on market trends, technology, and consumer behaviour. We offer tailored research services for global corporations and start-ups, helping them navigate the complex automotive landscape. With a focus on accuracy and integrity, we empower clients with data-driven insights to make informed decisions and stay competitive. Join us on this revolutionary journey as we work together as a strategic partner to reinvent your success in this ever-changing automotive world. 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