Johnson & Johnson (NYSE: JNJ) announced results from its Phase 3 MonumenTAL-3 study showing that TALVEY (talquetamab-tgvs) combined with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) with or without pomalidomide demonstrated a significant reduction in disease progression risk compared to standard treatment in patients with relapsed or refractory multiple myeloma.

The study showed progression-free survival rates of up to 81.3% and overall survival rates of up to 89.2% at 24 months for the combination treatments, compared to 51.2% and 79.1% respectively for the standard care regimen. The combination reduced the risk of disease progression or death by up to 72% and the risk of death by up to 53% compared to standard treatment.

Results were presented at the 2026 European Hematology Association Annual Meeting with simultaneous publication in The New England Journal of Medicine. This marks the first Phase 3 study to demonstrate superior progression-free survival with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma treatment.

The study evaluated 864 patients who had previously received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor. Most patients enrolled were refractory to lenalidomide and their last line of therapy.

Safety profiles for the TALVEY plus DARZALEX FASPRO treatment arms were consistent with known profiles of each individual therapy. The combination showed reduced rates of severe infections compared to standard care, with Grade 3/4 infection rates of 29.2% for TALVEY plus DARZALEX FASPRO alone, 37.7% for the three-drug combination, and 42.2% for standard treatment.

Based on these results, Johnson & Johnson has submitted regulatory applications to the U.S. Food and Drug Administration and European Medicines Agency seeking approval for the combination therapy in relapsed or refractory multiple myeloma patients after at least one prior line of therapy.