Johnson & Johnson (NYSE: JNJ) announced results from the Phase 3 MajesTEC-9 study showing TECVAYLI (teclistamab-cqyv) reduced the risk of disease progression or death by 71% and the risk of death by 40% compared to standard care in patients with relapsed or refractory multiple myeloma.

The study evaluated TECVAYLI versus standard care regimens in patients who received 1 to 3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody. Nearly two-thirds of patients receiving TECVAYLI achieved a complete response or better (65.9% vs. 16.8%).

The data were presented at the American Society of Clinical Oncology Annual Meeting and published simultaneously in The New England Journal of Medicine. The patient population was predominantly refractory to anti-CD38 therapy (85%) and lenalidomide (79%), with more than 90% refractory to their last line of therapy.

TECVAYLI demonstrated similar rates of treatment-emergent adverse events compared to standard care (99.7% vs. 97.9%). Grade 3/4 adverse events occurred in 84.9% of TECVAYLI patients versus 76.3% receiving standard care. Cytokine release syndrome occurred in 66% of TECVAYLI patients, mostly Grade 1.

Based on these results, Johnson & Johnson has submitted applications for regulatory approval to the U.S. Food and Drug Administration and European Medicines Agency for TECVAYLI use as early as second line treatment.

TECVAYLI received FDA approval in October 2022 for patients with relapsed or refractory multiple myeloma who received at least four prior lines of therapy. In March 2026, the FDA approved TECVAYLI in combination with DARZALEX FASPRO for patients who have received at least one prior line of therapy.