Johnson & Johnson announced Phase 3 MonumenTAL-3 study results for its multiple myeloma therapy at the 2026 European Hematology Association (EHA) Annual Meeting. The data showed TALVEY (talquetamab-tgvs) combined with DARZALEX FASPRO significantly reduced the risk of disease progression or death.
The trial evaluated the combination, with or without pomalidomide, against standard-of-care regimens in patients who received at least one prior therapy. Researchers followed participants for a median of approximately two years. The TALVEY combinations achieved a progression-free survival rate of 81.3%. The standard treatment group recorded a 51.2% progression-free survival rate.
Overall survival for the TALVEY combinations reached 89.2%. The standard regimen showed an overall survival rate of 79.1%. This study represents the first Phase 3 trial to demonstrate superior progression-free survival for a GPRC5D bispecific antibody combination in earlier-line treatment.
The New England Journal of Medicine published these findings, which support the regimen's potential as a new standard of care. Johnson & Johnson has submitted label expansion applications in the U.S. and EU based on this data.