Latest news with #Tecvayli
The Hindu
04-07-2025
- Business
- The Hindu
US FDA approves Regeneron's blood cancer therapy
Regeneron Pharmaceuticals said on Wednesday the U.S. Food and Drug Administration has approved its drug for a type of blood cancer called multiple myeloma that has recurred in patients who had received at least four other therapies earlier. Shares of the company rose 2% following the approval. The company said it is "working diligently" to make the therapy, branded Lynozyfic, commercially available as quickly as possible, and has set a wholesale acquisition cost of $470 per 5 mg vial and $18,800 per 200 mg vial. The accelerated approval was based on a mid-stage trial, in which 70% of patients on Lynozyfic saw their cancer shrink or disappear, while 45% achieved a complete disappearance of their cancer. Lynozyfic is a type of drug called monoclonal antibody that works by targeting two proteins - one found on myeloma cells known as BCMA and another one found on immune T-cells called CD3. These so-called "bispecific antibodies" are "paradigm shifting," Andres Sirulnik, Regeneron's clinical development head for hematology, said. Regeneron is exploring moving such drugs to earlier lines of therapy as they can replace many of the existing treatments used as a standard of care, Sirulnik added. Other bispecific antibodies approved for multiple myeloma are Johnson & Johnson's Tecvayli and Pfizer's Elrexfio. Like Elrexfio and Tecvayli, Lynozyfic comes with a boxed warning for neurologic toxicity and cytokine release syndrome, a condition where the immune system reacts more aggressively. Over 36,000 new cases of multiple myeloma are estimated to be diagnosed in the U.S. in 2025, according to the American Cancer Society. Regeneron estimates about 4,000 new cases will be among those who have received four or more lines of treatment.
Yahoo
03-07-2025
- Business
- Yahoo
Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma
Regeneron has won US Food and Drug Administration (FDA) approval for Lynozyfic (linvoseltamab-gcpt), marking the entry of another BCMAxCD3 bispecific drug in the multiple myeloma (MM) treatment space. Via an accelerated approval, Lynozyfic is indicated to treat adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Regeneron's drug joins two fellow BCMAxCD3 bispecific antibodies already at market in the US – Johnson & Johnson's (J&J) Tecvayli and Pfizer's Elrexfio. Despite playing catch-up with its rivals, Regeneron's product offers a dosing advantage. Lynozyfic, which stimulates T-cells to recognise and destroy cancer cells, can be administered monthly after 24 weeks of therapy, depending on how well the patient responds. Meanwhile, J&J's Tecvayli can be given every two weeks in patients who show a good response after at least six months, and Elrexfio has the same dosing interval from week 25 onward. Lynozyfic also has a fortnightly dosing schedule for patients starting from week 14. Regeneron's Phase I/II Linker-MM1 trial (NCT03761108) with Lynozyfic demonstrated an objective response rate of 70% in 80 patients with MM. Tecvayli and Elrexfio had response rates of 63% and 56% in their respective trials, though direct comparisons are difficult to draw without a head-to-head study. Boxed warnings are common for T-cell directing drugs, and Lynozyfic is no different. It comes with one for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-foetal toxicity. It is unclear how Regeneron will challenge J&J and Pfizer in MM, who both reached the market first but have less convenient dosing options. Justin Holko, Regeneron's senior vice-president for global oncology/haematology commercial business, told Pharmaceutical Technology: 'We don't comment on sales figures or market share, but believe Lynozyfic has the potential to provide significant benefit to multiple myeloma patients, society and the healthcare system.' Tecvayli generated $549m in 2024 while Elrexfio secured $133m. MM is the second most common blood cancer, and revenue for these drugs is expected to skyrocket. Tecvayli, for example, is forecast to reach nearly $4.5bn in annual sales by 2031, according to GlobalData's Pharma Intelligence Center. Similar analysis predicts Lynozyfic will generate $707m in sales by that year, a lower figure primarily due to Regeneron's later market entry. International Myeloma Foundation's interim CEO Diane Moran said: '[Lynozyfic] provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron's continued research to further advance treatment for this community.' "Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Business
- Yahoo
J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM). The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD). In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group. Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies. According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months. At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached. The combo was found to be consistent with prior reports of them as single agents. Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability. The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade. The study's findings were featured at the 2025 European Hematology Association Congress. EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options. 'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.' Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial. "J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Health
- Yahoo
EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM
At the 2025 Congress of the European Hematology Association (EHA 2025), held from 12 to 15 June, the preliminary results from the global, multi-centre open-label non-randomised Phase II RedirecTT-1 clinical trial (NCT04586426) were presented on 15 June. This trial evaluated the safety and efficacy of the combination of Johnson & Johnson's (J&J's) Tecvayli (teclistamab), an anti–G protein–coupled receptor family C group 5 member D (GPRC5D)-directed CD3 bispecific T-cell engager (BiTE) and Talvey (talquetamab), an anti–B-cell maturation antigen (BCMA)-CD3 BiTE, in treating patients with relapsed/refractory (r/r) multiple myeloma (MM) and extramedullary disease (EMD) who are already triple-class exposed (TCE) including proteasome inhibitor (PI), immunomodulatory drugs (IMiD), and an anti-CD38 monoclonal antibody. EMD is defined as soft tissue/organ-associated plasmacytomas that have no contact with bony structures. It represents an aggressive form of MM and occurs when myeloma cells spread and form tumours (plasmacytomas) in areas such as soft tissues and organs. EMD is commonly observed in haematologic malignancies such as MM, with a prevalence of roughly 6%–20% in r/r MM. The current standard of care (SOC) for patients with r/r MM with EMD includes combination regimens with PI, IMiD, or anti-CD38 monoclonal antibodies and may also involve chimeric antigen receptor (CAR)-T cell therapy or radiotherapy. Despite the promising efficacy of these advanced therapies, patients with MM and EMD consistently show lower response rates and shorter durations of remission across clinical trials compared to those with r/r MM without EMD. This highlights a significant unmet need for more effective therapeutic options in this high-risk population. According to GlobalData's Multiple Myeloma: Epidemiology Forecast to 2032 report, the number of diagnosed prevalent cases of MM in the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China) is projected to increase from 328,151 in 2025 to 352,348 by 2032 at an annual growth rate of 1.12%. The RedirecTT-1 trial is the largest EMD study to date, with 90 patients enrolled who were TCE. The investigational combination of Tecvayli and Talvey demonstrated a robust overall response rate (ORR) of 78.9% (95% CI: 69.0–86.8), with 54.4% achieving a complete response or better. Notably, high response rates were maintained even among patients previously treated with BCMA CAR-T (ORR: 83.3%, 95% CI: 58.6–96.4) and anti-FcRH5 bispecifics (ORR: 75.0%, 95% CI: 34.9–96.8). At a median follow-up of 13.4 months, 66.2% of responders remained in remission, indicating the potential for deep and sustained responses. Progression-free survival at one year was 61.0%, while 64.1% of patients maintained their responses, with a median duration of response of 13.8 months. Overall survival data had not yet matured, but the one-year survival rate was reported at 74.5%. Discontinuations due to adverse events (AEs) were infrequent; only four patients discontinued Talvey. Most cases of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were Grade 1 and 2. 10 patients (11.1%) experienced Grade 5 AEs, five of which were infection-related, consistent with infection rates observed in monotherapy studies involving BCMA-targeting bispecifics. The impressive results from the first oncology study to combine two bispecific antibodies are likely to reshape the SOC for patients with r/r MM and EMD. This dual-antigen targeting strategy enhances tumour cell recognition in a biologically and genetically heterogeneous patient population, helps overcome treatment resistance, and reduces the risk of relapse caused by antigen escape, particularly in those with EMD. Despite the strong efficacy and durability of response, the high incidence of Grade 3 and 4 infections and infection-related deaths highlights the need for careful consideration of dosing strategies and prophylactic interventions, including intravenous immunoglobulin, antibacterial, and antiviral therapies. In parallel, J&J is also advancing its BiTE portfolio through the Phase III MonumenTAL-6 clinical trial, which combines Tecvayli and Talvey, with results expected in 2026. J&J already dominates the MM market with Tecvayli, Talvey and its CAR-T cell therapy Carvykti (ciltacabtagene autoleucel), and is continuing to expand its pipeline. One of these assets, a trispecific T-cell engager, JNJ-79635322, is currently being evaluated in a Phase I clinical trial. It targets CD3, BCMA, and GPRC5D, and, if it progresses to later-stage trials and success, could become the first-in-class trispecific antibody in R/R MM. Its single-agent design offers a potential advantage in the overcrowded BiTE market, although it remains in early development. According to GlobalData's analyst consensus forecast, Tecvayli and Talvey are projected to generate global sales of $4.4bn and $1.8bn. respectively by 2031. "EHA 2025: J&J's dual-targeting bispecifics could redefine SOC for r/r MM" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
16-06-2025
- Business
- Yahoo
J&J reports results from antibody combo trial for MM patients
Johnson & Johnson (J&J) has reported new outcomes from the Phase II RedirecTT-1 trial of bispecific antibodies, Talvey (talquetamab-tgvs) and Tecvayli (teclistamab-cqyv) for relapsed/refractory multiple myeloma (r/r MM). The data showed a high overall response rate (ORR) with durability in those who have triple-class-exposed (TCE) RRMM with true extramedullary disease (EMD). In the trial, which enrolled 90 subjects, the investigational combo resulted in an ORR of 78.9%, with over half of the subjects achieving a complete response or better, representing a significant improvement over the average ORR of less than 40% for this patient group. Notably, responses were also found to be high among those previously treated with B-cell maturation antigen (BCMA) CAR-T or anti-FcRH5 bispecific antibodies. According to the company, subjects in the trial showed deep and durable responses, with 66.2% remaining in response at the data cutoff and a median follow-up of 13.4 months. At one year, 61% of subjects were progression-free and alive, and 74.5% were alive, with median overall survival not yet reached. The combo was found to be consistent with prior reports of them as single agents. Subjects had the option to switch to once-a-month dosing, which might have contributed to better tolerability. The reports of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were found to be mostly low grade. The study's findings were featured at the 2025 European Hematology Association Congress. EMD represents a severe form of MM, where myeloma cells form tumours in soft tissues and organs. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter said: 'Patients with extramedullary myeloma, especially those who have exhausted prior therapies, need more effective treatment options. 'Our first-in-class bispecific antibodies, Talvey and Tecvayli, have transformed treatment for relapsed or refractory multiple myeloma.' Recently, J&J reported that Tremfya decreased the symptoms and signs of active psoriatic arthritis (PsA) at 24 weeks in individuals against a placebo in the Phase IIIb APEX trial. "J&J reports results from antibody combo trial for MM patients" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error 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
