(RTTNews) - Johnson & Johnson (JNJ) announced new frontline data featuring TECVAYLI (teclistamab-cqyv) from two investigational studies in patients with newly diagnosed multiple myeloma (NDMM) 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. The 100 percent of evaluable patients for minimal residual disease (MRD) testing achieved MRD negativity in MajesTEC-5 as induction therapy and MajesTEC-4 as maintenance therapy.
Forty-nine patients with transplant-eligible NDMM were treated with TECVAYLI in combination with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), lenalidomide and dexamethasone (Tec-DRd) or DARZALEX FASPRO, bortezomib, lenalidomide and dexamethasone (Tec-DVRd) 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 (10-5) and maintained through cycle 6.
"These data from the MajesTEC-5 study build on the growing body of evidence of TECVAYLI combinations that support the potential combinability of TECVAYLI with other effective therapies, demonstrating high rates of MRD-negative responses for evaluable patients with newly diagnosed multiple myeloma," said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine.
According to the company, the safety profiles were manageable and consistent with individual safety profiles. No treatment-emergent adverse events (TEAEs) led to study treatment discontinuation or death; cytokine release syndrome occurred in 65 percent of patients.1 No patients experienced immune effector cell-associated neurotoxicity syndrome (ICANS).Grade 3/4 TEAEs included lymphopenia (43 percent), neutropenia (57 percent) and infections (35 percent).
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