On July 23, 2026 Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, reported 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
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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.
About MonumenTAL-6
MonumenTAL-6 (NCT06208150) is a global, randomized, Phase 3 study evaluating TECVAYLI plus TALVEY and TALVEY plus pomalidomide versus investigator’s choice of elotuzumab, pomalidomide and dexamethasone (EPd) or pomalidomide, bortezomib and dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma who have received one to four prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The primary endpoint is progression-free survival (PFS) as assessed by independent review committee. Key secondary endpoints include overall response rate (ORR), complete response or better (≥CR), MRD-negative complete response and overall survival (OS).
About Multiple Myeloma
Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the second most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8%.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.
(Press release, Johnson & Johnson, JUL 23, 2026, View Source;talvey-reduced-the-risk-of-disease-progression-or-death-by-89-and-the-risk-of-death-by-62-in-earlier-line-relapsedrefractory-multiple-myeloma-302833309.html [SID1234669402])