New TALVEY® (talquetamab-tgvs) plus DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) data demonstrate the strength of a bispecific combination in earlier-l

Johnson & Johnson announced results from the Phase 3 MonumenTAL-3 study at the 2026 European Hematology Association Annual Meeting, showing that TALVEY (talquetamab-tgvs) combined with DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) reduced the risk of disease progression or death by up to 72% compared to the standard regimen of DARZALEX FASPRO, pomalidomide, and dexamethasone in patients with relapsed or refractory multiple myeloma. The study included patients who had received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

The trial demonstrated a progression-free survival rate of up to 81.3% for the combination therapy versus 51.2% for the standard regimen at 24 months. Overall survival rates were 89.2% for the combination versus 79.1% for the standard treatment. The study also showed higher overall response rates and deeper responses, including minimal residual disease negativity, for the combination therapies compared to the standard regimen.

TALVEY targets the GPRC5D protein, which is highly expressed on multiple myeloma cells but largely absent on healthy B-cells, allowing the therapy to spare normal immune cells. The combination with DARZALEX FASPRO, a CD38-directed antibody, aims to enhance efficacy while maintaining a manageable safety profile. The results were published simultaneously in The New England Journal of Medicine.

Johnson & Johnson has submitted a supplemental Biologics License Application to the U.S. FDA and a Type II variation application to the European Medicines Agency for the combination therapy. The company is working with regulatory bodies to bring this treatment option to eligible patients as quickly as possible, following the submission of data from the MonumenTAL-3 study.