Johnson & Johnson reported topline results from the Phase 3 MajesTEC-9 study evaluating Tecvayli (teclistamab-cqyv) monotherapy in patients with relapsed or refractory multiple myeloma who had received one to three prior lines of therapy. The trial met its primary endpoint, showing a 71% reduction in the risk of disease progression or death compared with standard regimens of pomalidomide-based or carfilzomib-based combination therapy. In addition, Tecvayli achieved a 40% reduction in the risk of death. The study population was predominantly refractory to anti-CD38 agents and lenalidomide, underscoring the agent’s activity in a heavily pretreated cohort. An independent monitoring committee recommended unblinding following this first interim analysis, reflecting the strength of the data.

The safety findings for Tecvayli monotherapy were consistent with the known profile of bispecific T-cell engagers, with no new safety signals identified. Adverse events were manageable using established step-up dosing and cytokine release management protocols. Johnson & Johnson plans to present full data at a major medical congress later this year and will share results with global health authorities to support potential label expansion as early as first relapse.

In parallel, J&J disclosed longer-term results from the OrigAMI-1 study of Rybrevant (amivantamab-vmjw) plus FOLFOX or FOLFIRI chemotherapy in patients with RAS/BRAF wild-type metastatic colorectal cancer. Preliminary findings indicate durable response rates above historical benchmarks and low discontinuation rates due to treatment-related events. These results bolster the rationale for ongoing Phase 3 trials in first- and second-line settings and may inform future registration strategies in colorectal cancer.