Johnson & Johnson’s Phase 3 MajesTEC‑9 trial shows TECVAYLI® cut risk of progression or death by 71% and improved overall survival in relapsed multiple myeloma, reinforcing its role in earlier treatment lines.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Johnson & Johnson reported positive Phase 3 MajesTEC-9 (NCT05572515) results showing that TECVAYLI® (teclistamab-cqyv) significantly improved progression-free and overall survival in patients with relapsed or refractory multiple myeloma (RRMM).
In MajesTEC‑9, TECVAYLI monotherapy was evaluated against physician’s choice of pomalidomide, bortezomib and dexamethasone (PVd) or carfilzomib plus dexamethasone (Kd). The study enrolled patients with one to three prior lines of therapy, all of whom had previously received lenalidomide and an anti‑CD38 monoclonal antibody.
The study enrolled a refractory population: 85% were refractory to anti‑CD38 therapy, 79% to lenalidomide, and more than 90% to their most recent regimen.
Efficacy Results
Treatment with TECVAYLI reduced the risk of disease progression or death by 71% compared with standard regimens (HR=0.29; 95% CI: 0.23–0.38). Overall survival improved with a 40% reduction in risk of death (HR=0.60; 95% CI: 0.43–0.83).
Deep responses were observed, with 65.9% of TECVAYLI‑treated patients achieving complete response or better versus 16.8% in the control arm.
Median treatment duration was 13.1 months with TECVAYLI compared with 7.0 months for standard therapy, underscoring durability. All secondary endpoints including depth and duration of response, time to next treatment, and progression‑free survival on subsequent therapy favored TECVAYLI.
“These findings further reinforce TECVAYLI’s potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines of treatment,” said Roberto Mina, M.D., Associate Professor at the Winship Cancer Institute of Emory University.
Safety Profile
The safety profile was consistent with prior studies. Treatment‑emergent adverse events occurred in 99.7% of TECVAYLI patients and 97.9% of controls, with Grade 3/4 events in 84.9% and 76.3%, respectively. Grade 5 events were uncommon (6.5% vs. 3.5%) and largely infection‑related, occurring early in therapy. Severe infections (Grade 3/4) were more frequent with TECVAYLI (41.6% vs. 29.0%) but decreased over time as disease control improved. Cytokine release syndrome was reported in 66% of patients, predominantly Grade 1, and resolved with standard mitigation strategies.
Immune effector cell‑associated neurotoxicity syndrome was infrequent (4.1%), limited to Grade 1/2, and did not lead to discontinuation.
Regulatory Outlook
The results build on the March 2026 U.S. FDA approval of TECVAYLI in combination with DARZALEX FASPRO® for adults with RRMM after at least one prior line of therapy, the first approved bispecific antibody‑based combination in this setting.
Johnson & Johnson has submitted applications to the FDA and EMA seeking approval for TECVAYLI as early as second‑line treatment.
The MajesTEC‑9 findings, presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine, further strengthen the evidence base supporting TECVAYLI’s role in earlier disease management and further support the use of TECVAYLI in earlier lines of treatment for relapsed or refractory multiple myeloma.
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About the Writer
Chikkula Pavan Kumar (LinkedIn), PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.