Background and Key Findings
Johnson & Johnson announced positive results from the Phase 3 MajesTEC-9 study evaluating TECVAYLI® (teclistamab-cqyv), a bispecific T-cell engager antibody, versus standard of care (pomalidomide/bortezomib/dexamethasone or carfilzomib/dexamethasone) in patients with relapsed/refractory multiple myeloma who had received 1-3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody. Key findings:
- 71% reduction in risk of disease progression or death (HR=0.29; 95% CI 0.23-0.38)
- 40% reduction in risk of death (HR=0.60; 95% CI 0.43-0.83)
- Nearly two-thirds of patients achieved a complete response or better (≥CR: 65.9% vs 16.8%)
These data were presented as an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.
Expert Commentary
“These findings further reinforce TECVAYLI's potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines,” said Dr. Roberto Mina, Associate Professor at Winship Cancer Institute of Emory University. “The results offer a steroid-sparing, community-based therapy option for patients across all practice settings.” Dr. Yusri Elsayed, Global Therapeutic Area Head, Oncology at Johnson & Johnson, added that following the recent approval of TECVAYLI plus DARZALEX FASPRO, these results add to the evidence supporting TECVAYLI earlier in the treatment paradigm.
Safety Profile
The overall safety profile of TECVAYLI was consistent with its known profile. Treatment-emergent adverse events (TEAEs) occurred at similar rates (99.7% vs 97.9%), with Grade 3/4 TEAEs in 84.9% of patients receiving TECVAYLI vs 76.3% on standard of care. Infections were more frequent (Grade 3/4: 41.6% vs 29.0%) but declined over time with disease control. Cytokine release syndrome occurred in 66.0% of patients, mostly Grade 1 and manageable with standard mitigation; no events led to discontinuation. Immune effector cell-associated neurotoxicity syndrome was infrequent (4.1%), primarily Grade 1/2.
Regulatory Next Steps
Based on these results, Johnson & Johnson has submitted applications to the U.S. FDA and the European Medicines Agency (EMA) for approval of TECVAYLI as early as second-line therapy. This could potentially establish a new standard of care for multiple myeloma patients at first relapse.