J&J announces new frontline data featuring TECVAYLI fro 2 studies in NDMM

Johnson & Johnson announced new frontline data featuring TECVAYLI from two investigational studies in patients with newly diagnosed multiple myeloma in induction and maintenance settings. The MajesTEC-5 and MajesTEC-4 studies establish the potential of TECVAYLI for use in newly diagnosed patients, with promising efficacy and a tolerable safety profile. These data were highlighted as oral presentations at the 2024 American Society of Hematology Annual Meeting. Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI in combination with DARZALEX FASPRO, lenalidomide and dexamethasone or DARZALEX FASPRO, bortezomib, lenalidomide and dexamethasone as induction therapy in the MajesTEC-5 study. All patients who were evaluated for MRD negativity after cycle 3 of induction therapy achieved MRD negativity and maintained through cycle 6. The safety profiles were manageable and consistent with individual safety profiles. No treatment-emergent adverse events led to study treatment discontinuation or death; cytokine release syndrome occurred in 65 percent of patients. No patients experienced immune effector cell-associated neurotoxicity syndrome. Grade 3/4 TEAEs included lymphopenia, neutropenia and infections. Results from the safety run-in of the Phase 3 MajesTEC-4 study highlighted the potential of TECVAYLI to be administered as a maintenance therapy following autologous stem cell transplant. MajesTEC-4 is the first study to present data on a B-cell maturation antigen bispecific as monotherapy or combination therapy after ASCT. Low rates of non-hematologic Grade 3/4 TEAEs and discontinuation of treatment due to all TEAEs were observed. CRS events were all Grade 1/2, mostly occurring during step-up dosing, and ICANS was not observed. Neutropenia and infections were the most common Grade 3/4 TEAEs. Grade 3/4 neutropenia at 6 months showed a decreased trend in cohorts 2 and 3 with less frequent TECVAYLI dosing. A similar trend was observed for all-grade infections. All evaluable patients in cohort 1 who underwent MRD assessment after 12 months of therapy were MRD negative, and 100 percent of evaluable patients assessed in cohorts 2 and 3 were also MRD negative at cycle 6. Further analysis of combination therapies will be evaluated in the Phase 3 MajesTEC-7 study, which is currently enrolling.