Johnson & Johnson (JNJ) has released frontline data highlighting TECVAYLI (teclistamab-cqyv) from two investigational studies conducted with patients newly diagnosed with multiple myeloma (NDMM). These studies, named MajesTEC-5 and MajesTEC-4, explore TECVAYLI in both induction and maintenance settings, suggesting its promising efficacy and manageable safety in newly diagnosed patients. Remarkably, all patients evaluated for minimal residual disease (MRD) in these studies achieved MRD negativity – in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy.
In the MajesTEC-5 study, 49 patients eligible for transplant and diagnosed with NDMM were administered TECVAYLI, alongside DARZALEX FASPRO (a combination of daratumumab and hyaluronidase-fihj), lenalidomide, and dexamethasone (Tec-DRd), or with DARZALEX FASPRO, bortezomib, lenalidomide, and dexamethasone (Tec-DVRd) during induction therapy. All patients who were monitored for MRD negativity after the third cycle of induction therapy achieved this status at the level of 10^-5, maintaining it through the sixth cycle.
"This data from the MajesTEC-5 study adds to the growing evidence that supports the potential of combining TECVAYLI with other effective therapies, showing high rates of MRD-negative responses among newly diagnosed multiple myeloma patients who were evaluable," stated Rachel Kobos, M.D., Vice President of Oncology Research & Development at Johnson & Johnson Innovative Medicine.
The company assured that the safety profiles were manageable and aligned with expected profiles for individual treatments. No treatment-emergent adverse events (TEAEs) led to discontinuation or death in the study. While 65 percent of patients experienced cytokine release syndrome, none suffered from immune effector cell-associated neurotoxicity syndrome (ICANS). The Grade 3/4 TEAEs observed included lymphopenia (43%), neutropenia (57%), and infections (35%).
