Johnson & Johnson (JNJ) on Thursday reported positive results from the Phase 3 MonumenTAL-6 trial, with both the Tecvayli plus Talvey and Talvey with pomalidomide treatment arms exhibiting significant improvements in progression-free survival and overall survival in patients with relapsed or refractory multiple myeloma who had previously received an anti-CD38 antibody and lenalidomide.
Talvey is a bispecific T-cell engaging antibody that targets the CD3 receptor expressed on the T-cell and G protein-coupled receptor class C group 5 member D (GPRC5D) surface.
Talvey, as monotherapy, was granted accelerated approval by the FDA in 2023 for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
Meanwhile, the therapy was granted conditional marketing authorization by the European Commission in August 2023 for therapy in patients with R/R MM who previously received three lines of therapies.
Tecvayli is a bispecific T-cell engager antibody therapy that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) which are expressed on the surface of multiple myeloma cells. The FDA granted accelerated approval for Tecvayli in October 2022 as a ready to use subcutaneous treatment for patients with R/R MM who previously received four lines of therapy. In the Phase 3 MonumenTAL-6 study, both the Tec-Tal and Tal-P regimens met the primary endpoint by significantly improving progression-free survival (PFS) against investigator's choice of standard-of-care regimens.
Tec-Tal arm reduced the risk of disease progression or death by 89%, while Tal-P arm reduced the risk by 73%. The safety profiles of both combinations were consistent with the known safety profiles of the individual therapies.
Based on the positive interim results, the Independent Data Monitoring Committee recommended unblinding the study, with full data to be presented at a future medical meeting which is submitted to global health authorities.
Multiple myeloma is a type of blood cancer that affects the white blood cells (plasma cells). The plasma cells rapidly proliferate in the bone marrow, replacing normal cells with tumors. People with multiple myeloma have a 5-year survival rate of 59.8%, and those who have failed at least two immunomodulatory drugs, two proteasome inhibitors, and a CD38-targeting therapy are classified as R/R MM.
The company added that it is the fifth positive Phase 3 study evaluating its multiple myeloma T-cell therapy portfolio in second line, which further strengthens its leadership and commitment to advancing immunotherapy-based regimens earlier in the treatment journey.
JNJ is trading up 0.56% at $257.05.
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September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.