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JNJ.comStock Titan+1JNJ.comJohnson & Johnson on Wednesday announced that the phase 3 MonumenTAL-6 trial met its primary endpoint, with the combination of Tecvayli (teclistamab) and Talvey (talquetamab) reducing the risk of disease progression or death by 89% and the risk of death by 62% in patients with relapsed or refractory multiple myeloma. The dual-target regimen, which simultaneously attacks myeloma cells through two distinct surface proteins — BCMA and GPRC5D — produced the lowest hazard ratio seen in any phase 3 study of bispecific therapies in this disease, according to the company.Stock Titan
The three-arm trial compared Tecvayli plus Talvey (Tec-Tal) and Talvey plus pomalidomide (Tal-P) against investigator's choice standard of care in patients who had received one to four prior lines of treatment. Both experimental arms achieved statistically significant improvements in progression-free survival. The Tec-Tal combination delivered a hazard ratio of 0.11 (95% CI, 0.08–0.16; p<0.0001), while the Tal-P arm reduced the risk of progression or death by 73% (HR 0.27; 95% CI, 0.20–0.35). Safety profiles for both investigational arms were consistent with those observed with each drug as monotherapy.JNJ.com+1
Based on the strength of the data, the Independent Data Monitoring Committee recommended unblinding the study at its first interim analysis. Full results will be presented at a future medical meeting and shared with global health authorities.Stock Titan
MonumenTAL-6 marks the fifth positive phase 3 study from J&J's myeloma T-cell therapy portfolio in the second-line setting. It follows recent results from the MajesTEC-9 trial, which showed Tecvayli monotherapy reduced progression or death risk by 71% and death risk by 40% versus standard care, as well as the MonumenTAL-3 study presented at the 2026 European Hematology Association Congress, where Talvey combined with Darzalex Faspro cut progression or death risk by up to 72%.EMEA Innovative Medicine+2
"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, Director of the Myeloma Program at Emory University School of Medicine. Yusri Elsayed, J&J's global oncology head, called the data further evidence that "immunotherapy is a cornerstone of multiple myeloma care". Tecvayli received FDA approval in March 2026 for use as early as second line in combination with Darzalex Faspro, and more than 30,700 patients have been treated with the drug worldwide.JNJ.com+1