Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced new data from the Phase 3 MajesTEC-9 study demonstrating clinically meaningful and statistically significant improvements in progression-free survival (PFS) and overall survival (OS) with TECVAYLI® (teclistamab-cqyv) versus standard of care regimens in patients with relapsed or refractory multiple myeloma treated as early as second line. In a patient population whose myeloma was predominantly refractory to anti-CD38 therapy and lenalidomide, TECVAYLI® reduced the risk of disease progression or death by 71% and the risk of death by 40%.1 These data (Abstract #7507) will be presented as an oral session today at the annual American Society of Clinical Oncology (ASCO) Annual Meeting, with simultaneous publication in The New England Journal of Medicine.

(PRNewsfoto/Johnson & Johnson)

Expert and company perspectives support the strength of TECVAYLI®

"These findings further reinforce TECVAYLI's potential to meaningfully improve survival outcomes for patients with multiple myeloma in earlier lines," said Roberto Mina, M.D., Associate Professor, Winship Cancer Institute of Emory University.* "These results will continue to transform the role of bispecifics in clinical decision-making as early as first relapse—offering a steroid-sparing, community-based therapy for patients across all practice settings, regardless of prior anti-CD38 exposure."

"After the recent approval of TECVAYLI plus DARZALEX FASPRO, a potential new standard of care, these results add to the growing body of evidence reinforcing the clinical power of TECVAYLI earlier in the treatment paradigm," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further demonstrate how we're leading in multiple myeloma as we bring new options to better match the right therapy to the right patient at each stage of disease."

MajesTEC-9 study results

The MajesTEC-9 study evaluated TECVAYLI®, a bispecific T-cell engager antibody therapy, versus the standard of care of pomalidomide, bortezomib, and dexamethasone (PVd) or carfilzomib and dexamethasone (Kd) in patients with relapsed/refractory multiple myeloma who have received 1 to 3 prior lines of therapy, including lenalidomide and a CD38 monoclonal antibody.1 Efficacy benefits were observed in a heavily pre-treated population, including patients predominantly refractory to anti-CD38 monoclonal antibodies (85%) and lenalidomide (79%), and more than 90% of patients who were refractory to their last line of therapy.1 Treatment with TECVAYLI® demonstrated a 71% reduction in the risk of disease progression or death (hazard ratio [HR]=0.29; 95% confidence interval [CI], 0.23, 0.38) and a 40% reduction in the risk of death (HR=0.60; 95% CI, 0.43, 0.83)] compared to standard of care, demonstrating significant improvements in both PFS and OS.1 Additionally, all key secondary endpoints showed significant improvement with TECVAYLI® versus standard of care, including nearly two-thirds of patients achieving a complete response or better (≥CR; 65.9% vs. 16.8%).1

The overall safety profile for TECVAYLI® in the study was consistent with its known safety profile. TECVAYLI® had similar rates of treatment-emergent adverse events (TEAEs) compared to standard of care (99.7% vs. 97.9%).1 Grade 3/4 TEAEs were reported by 84.9% of patients treated with TECVAYLI®, compared with 76.3% of patients receiving standard of care.1 Grade 5 TEAEs were uncommon across the two treatment groups (6.5% vs. 3.5%).1 The majority of Grade 5 TEAEs in both groups were due to infections (5.5% vs. 2.8%) and most occurred within the first six months of treatment initiation.1 Infections were more frequent with TECVAYLI® compared to standard of care (Grade 3/4, 41.6% vs. 29.0%); However, rates of Grade 3 or higher infections declined over time with disease control.1 Cytokine release syndrome occurred in 66.0% of patients treated with TECVAYLI®, mostly Grade 1 and managed with standard mitigation strategies.1 All events resolved and none led to treatment discontinuation.1 Immune effector cell-associated neurotoxicity syndrome was infrequent, occurring in 4.1% of patients and primarily Grade 1/2.1 Median duration of treatment on TECVAYLI® was almost two times longer than standard of care (13.1 vs 7.0 months).1

Regulatory review and next steps

Based on these results, Johnson & Johnson is working with regulatory bodies globally to consider TECVAYLI® as early as second line. Applications for regulatory approval have been submitted to the U.S. Food and Drug Administration and the European Medicines Agency (EMA).