Johnson & Johnson (NYSE:JNJ), a worldwide leader in multiple myeloma therapies, today announced positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating TECVAYLI® (teclistamab-cqyv) + TALVEY® (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and TALVEY® + pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received 1 to 4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.1 The study demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator's choice standard of care. TECVAYLI® + TALVEY® delivered the greatest benefit, reducing the risk of disease progression or death by 89% (HR, 0.11) and the risk of death by 62% (HR, 0.38).1 This represents the lowest hazard ratio seen across any Phase 3 study evaluating bispecific therapies in relapsed/refractory multiple myeloma.1

Expert and company perspectives reinforce the potential of TECVAYLI® + TALVEY®

"These findings add to a growing body of Phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey," said Ajay K. Nooka, M.D., M.P.H., F.A.C.P., Director, Myeloma Program, Department of Hematology and Medical Oncology, Emory University School of Medicine.* "TECVAYLI and TALVEY together generated deep and durable responses, demonstrating what's possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off-the-shelf regimen to improve outcomes for patients across practice settings."

"At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care and strengthen the growing body of evidence supporting our leadership in this space. By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease."

Topline results from the Phase 3 MonumenTAL-6 study

The MonumenTAL-6 study evaluated TECVAYLI® in combination with TALVEY® (Tec-Tal) or TALVEY® with pomalidomide (Tal-P) compared to the investigator's choice of either elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in participants with RRMM who have received at least one line of therapy, including an anti-CD38 antibody and lenalidomide.1 Both the Tec-Tal and Tal-P regimens met the study's primary endpoint of PFS, demonstrating statistically significant and clinically meaningful improvements versus standard of care.1 Risk of progression or death was reduced in the Tec-Tal arm by 89% (hazard ratio [HR], 0.11; 95% confidence interval [CI], 0.08-0.16; p<0.0001) and 73% (HR, 0.27; 95% CI, 0.2-0.35) in the Tal-P arm.1 The overall safety profiles for the Tec-Tal and Tal-P treatment arms were consistent with the known safety profiles of each monotherapy.

Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study at the first interim analysis. The full results of the Phase 3 MonumenTAL-6 study will be presented at a future major medical meeting and shared with global health authorities.