Johnson & Johnson's Investigational Bispecific Antibody Combination of TALVEY® and TECVAYLI® Demonstrates Deep and Durable Responses in Heavily Pretreated Multiple Myeloma Patients with Extramedullary Disease
Johnson & Johnson
Medical Device R&D and Manufacturer
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Recently, Johnson & Johnson announced the Phase 2 RedirecTT-1Dual TCE Bispecific Antibody CombinationThe latest results of the study. The study evaluates the combination regimen of GPRC5D TCE bispecific antibody TALVEY® (talquetamab-tgvs) and BCMA TCE bispecific antibody TECVAYLI® (teclistamab-cqyv).《The 11th Bispecific Antibody: Johnson & Johnson's GPRC5D/CD3 Bispecific Antibody Approved for Marketing》《The 7th Bispecific Antibody! Johnson & Johnson's BCMA/CD3 Bispecific Antibody Approved for Marketing》Data show that this innovative therapy has demonstrated a high overall response rate (ORR) and durable efficacy in triple-exposed relapsed/refractory multiple myeloma (RRMM) patients with extramedullary disease (EMD).Extramedullary Disease (EMD) in Multiple Myeloma (MM) is an aggressive and poor-prognosis disease subtype, posing significant treatment challenges.。Traditional therapies (such as proteasome inhibitors, immunomodulators, CD38 monoclonal antibodies) typically result in an ORR of less than 40% in EMD patients, with a median PFS of less than 6 months.，EMD patients are often accompanied by high-risk cytogenetic abnormalities (such as del(17p), 1q21+),Lead to treatment resistance.RedirecTT-1 is the largest scale to dateLarge-Scale Special Study on EMD Patients, Data Presented as a Key Oral Report (Abstract Number#LB4001) Released at the 2025 European Hematology Association (EHA) Annual Meeting.
The phase 2 RedirecTT-1 study enrolled 90 patients with TCE RRMM and true EMD, of whom 84.4% were triple-class refractory, 35.6% were penta-class refractory, 20% had previously received BCMA CAR-T therapy, and 8.9% had prior bispecific antibody treatment. The study showed,TALVEY® in combination with TECVAYLI® achieved an ORR of 78.9% (95% [CI]: 69.0-86.8), with over half of the patients (54.4%) achieving complete response or better efficacy.。High response rates (ORR of 83.3% and 75%, respectively) were still observed in patients previously treated with BCMA CAR-T or anti-FcRH5 bispecific antibodies.As of the data cutoff point, 66.2% of responders continued to show sustained relief after a median follow-up of 13.4 months, demonstrating deep and durable efficacy. In the combination therapy group, 61% of patients had progression-free survival at one year, 64.1% maintained relief (median duration of relief was 13.8 months), the one-year survival rate reached 74.5%, and the median overall survival had not yet been reached.
By contrast, in the Majestec-1 specifically targeting extramedullary lesionsIn the Monumental-1 trial, the ORR of Tecvayli and Talvey as monotherapy was only 36% and 48%, respectively. BCMA CAR-T: Such as Carvykti (Ciltacabtagene Autoleucel), while it performs well in RRMM, its effect on EMD patients...SimilarlyPoor, with an ORR of approximately 50%-60%, and a high recurrence rate.
Safety Aspect: The safety of combination therapy is consistent with previous reports on monotherapy, and no new safety signals were identified.Patients can be transitioned to a once-monthly dosing regimen, with potential improvement in tolerability. The discontinuation rate of the combination therapy of TALVEY® and TECVAYLI® due to adverse events (AE) was low, with only two patients discontinuing TALVEY®. Most cases of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) were of low grade. Among the 10 patients who experienced Grade 5 AEs (11.1%), 5 were infection-related, and 5 were unrelated. The incidence of serious infections was comparable to that observed with BCMA bispecific antibody monotherapy.
The investigational combination regimen of TALVEY and TECVAYLI has demonstrated deep and durable responses in patients with relapsed/refractory multiple myeloma and is now showing significant potential in extramedullary myeloma patients who have poor responses to conventional therapies. By simultaneously targeting GPRC5D and BCMA, this regimen may achieve higher ORR and deeper responses by reducing target antigen escape.
Currently, Johnson & Johnson's layout in the MM field has covered from newly diagnosed first-line treatments to heavily relapsed/refractory RR/MM. In terms of drug formats, they have not missed out on small molecules, monoclonal antibodies, bispecific antibodies, or CAR-T. On this basis, the development of bispecific antibody combinations, bispecific/monoclonal antibody combinations, and even trispecific antibodies will continuously solidify its dominant position in the MM field. It’s hard not to admire Johnson & Johnson’s strategy in the MM field, which is also worth learning from and emulating by companies in China.！
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