Johnson & Johnson has announced positive topline results from the phase 3 MonumenTAL‑6 study, which evaluated TECVAYLI and TALVEY as a dual antigen regimen targeting BCMA and GPRC5D in adults with relapsed or refractory multiple myeloma. The trial also assessed TALVEY with pomalidomide. Both investigational arms were compared with investigator’s choice standard of care.
The company reported statistically significant improvements in progression‑free survival and overall survival for both investigational regimens. TECVAYLI plus TALVEY delivered the strongest benefit, reducing the risk of disease progression or death by 89% and the risk of death by 62%.
Ajay K Nooka, Director of Myeloma Program at Emory University School of Medicine, said: “These findings add to a growing body of phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey.”
He added: “TECVAYLI and TALVEY together generated deep and durable responses, demonstrating what’s possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off‑the‑shelf regimen to improve outcomes for patients across practice settings.”
Yusri Elsayed, Global Therapeutic Area Head, Oncology, Johnson & Johnson, explained: “At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey.”
He continued: “These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care and strengthen the growing body of evidence supporting our leadership in this space. By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease.”
The Independent Data Monitoring Committee recommended unblinding the study at the first interim analysis. Full results will be presented at a future medical meeting and shared with global health authorities.
