TECVAYLI® monotherapy demonstrates superior progression-free and overall survival versus standard of care as early as first relapse in patients with multiple myeloma predominantly refractory to anti-CD38 therapy and lenalidomide

Core Insights - Johnson & Johnson announced positive topline results from the Phase 3 MajesTEC-9 study, demonstrating that TECVAYLI monotherapy reduced the risk of disease progression or death by 71% and the risk of death by 40% in a patient population largely refractory to existing therapies [1][5][6] Group 1: Study Results - The MajesTEC-9 study confirmed superior progression-free survival (PFS) and overall survival (OS) with TECVAYLI compared to standard care as early as second line therapy [1][2] - The study involved patients who were predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), with over 90% being refractory to their last line of therapy [4][5] - TECVAYLI's safety profile was manageable, with no new safety concerns identified, and the Independent Data Monitoring Committee recommended unblinding the study based on the strength of the data [5][6] Group 2: Treatment Context - Multiple myeloma is characterized by high relapse rates and a significant unmet need for additional therapies, particularly for patients refractory to commonly used treatments [2][3] - The results from MajesTEC-9 build on previous findings from the MajesTEC-3 study, which showed significant benefits of TECVAYLI in combination with DARZALEX FASPRO for patients who were naïve or sensitive to anti-CD38 therapy [2][3] Group 3: Future Implications - The results from the MajesTEC-9 study position TECVAYLI as a potential new standard of care for multiple myeloma treatment, particularly for patients experiencing their first relapse [3][6] - Johnson & Johnson continues to innovate in the multiple myeloma space, aiming to redefine treatment options and improve outcomes for patients at all stages of the disease [6][8]