J&J Reports Positive Phase 3 MajesTEC-9 Results for Tecvayli in Earlier Multiple Myeloma
Johnson & Johnson announced positive topline results from the Phase 3 MajesTEC-9 study on January 14, 2026, showing TECVAYLI (teclistamab-cqyv) monotherapy superior to standard of care in relapsed/refractory multiple myeloma as early as first or second relapse.124
TECVAYLI reduced the risk of disease progression or death by 71% and the risk of death by 40% in patients predominantly refractory to anti-CD38 therapy (85%) and lenalidomide (79%).234
The study population had received 1-3 prior lines of therapy, with over 90% refractory to their most recent treatment, addressing high unmet need in earlier lines.234
TECVAYLI is a first-in-class bispecific T-cell engager targeting BCMA and CD3; full results to be presented at a future medical meeting and shared with health authorities.2
This is the second positive Phase 3 for TECVAYLI in myeloma, following MajesTEC-3, strengthening its case for earlier use.14
Sources:
1. https://firstwordpharma.com/story/7064828
2. https://www.jnj.com/media-center/press-releases/tecvayli-monotherapy-demonstrates-superior-progression-free-and-overall-survival-versus-standard-of-care-as-early-as-first-relapse-in-patients-with-multiple-myeloma-predominantly-refractory-to-anti-cd38-therapy-and-lenalidomide
3. https://www.curetoday.com/view/tecvayli-associated-with-reduced-risk-of-multiple-myeloma-progression-or-death
4. https://www.pharmacytimes.com/view/phase-3-majestec-9-trial-shows-survival-benefit-with-teclistamab-in-multiple-myeloma