Johnson & Johnson (JNJ) announced positive results from its Phase 3 MonumenTAL-3 trial evaluating Talvey in combination with Darzalex Faspro, with or without pomalidomide, for the treatment of patients with relapsed/refractory Multiple Myeloma.
Talvey, as monotherapy, was granted accelerated approval by the FDA in 2023 for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
In the phase 3 MonumenTAL-3 trial, TALVEY plus DARZALEX FASPRO with or without pomalidomide reduced the risk of disease progression or death by up to 72% and lowered the risk of death by up to 53% compared with the standard DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd) regimen. Moreover, at 24 months, the TALVEY combination regimen with or without pomalidomide demonstrated a progression-free survival rate of 81.3% versus 51.2% with standard therapy, while overall survival was 89.2% versus 79.1%, respectively.
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.
Based on these results, the company has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of Talvey and Darzalex Faspro, with or without pomalidomide, as a combination treatment for R/R MM after at least one prior line of therapy. A Type II variation application has also been submitted to the European Medicines Agency (EMA).
Johnson & Johnson shares are currently trading at $236.26, down 1.91%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.