Johnson & Johnson’s tecvayli shows efficacy in Phase 3 multiple myeloma study

Johnson & Johnson announced positive topline results from the investigational Phase 3 MajesTEC-9 study of tecvayli – teclistamab-cqyv – monotherapy, showing a 71% reduction in the risk of disease progression or death and a 40% reduction in the risk of death in a patient population that was predominantly refractory to anti-CD38 therapy and lenalidomide. Data confirm superior progression-free survival and overall survival with tecvayli vs. standard of care as early as second line. Despite recent advances in multiple myeloma treatment, a significant unmet need remains for additional, well-tolerated therapies, particularly for patients refractory to commonly used medications in multiple myeloma. The safety profile of tecvayli monotherapy was clinically manageable, with no new safety concerns identified. Topline data were confirmed following this first pre-specified interim analysis. Based on the strength of the data, the Independent Data Monitoring Committee recommended unblinding the study. The full results of the Phase 3 MajesTEC-9 study will be presented at a future major medical meeting and shared with global health authorities.