Johnson & Johnson reported positive topline results from MonumenTAL-6, a Phase 3 study evaluating TECVAYLI plus TALVEY in adults with relapsed or refractory multiple myeloma who had received one to four prior lines of therapy. The company said the dual-antigen regimen targeting BCMA and GPRC5D reduced the risk of disease progression or death by 89% and the risk of death by 62% versus investigator’s choice standard of care.
The trial is the first and only Phase 3 study of a BCMA and GPRC5D dual-antigen regimen in relapsed/refractory multiple myeloma. Johnson & Johnson said the findings mark its fifth positive Phase 3 study in second-line multiple myeloma and further support its strategy of moving immunotherapy-based regimens earlier in the treatment journey.
MonumenTAL-6 compared TECVAYLI plus TALVEY, TALVEY plus pomalidomide, and investigator’s choice of elotuzumab, pomalidomide and dexamethasone or pomalidomide, bortezomib and dexamethasone in patients who had already received an anti-CD38 antibody and lenalidomide. Both investigational arms met the primary endpoint of progression-free survival and showed statistically significant and clinically meaningful improvements versus standard of care. The Tec-Tal arm delivered the strongest benefit, with a hazard ratio of 0.11 for progression or death and 0.38 for death.
Johnson & Johnson said the safety profiles in both arms were consistent with the known profiles of each monotherapy. Based on the strength of the data, the study’s Independent Data Monitoring Committee recommended unblinding at the first interim analysis.
Company leaders said the results reinforce immunotherapy as a cornerstone of myeloma care and expand evidence supporting the company’s broad portfolio across biological targets, mechanisms, modalities and lines of therapy. Full results will be presented at a future medical meeting and shared with health authorities.
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