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J&J Trial Shows Bispecific Combination Boosts Myeloma Survival

New Phase 3 data from the MonumenTAL-3 study demonstrates that combining TALVEY with DARZALEX FASPRO reduces the risk of disease progression or death by up to 72% in patients with relapsed or refractory multiple myeloma, marking a significant shift toward earlier-line use of bispecific immunotherapies.

J&J Trial Shows Bispecific Combination Boosts Myeloma Survival

The clinical trial, results of which were presented at the 2026 European Hematology Association Annual Meeting and published in The New England Journal of Medicine, evaluated the efficacy of TALVEY (talquetamab-tgvs) when paired with DARZALEX FASPRO, both with and without the addition of pomalidomide. At a median follow-up of 24.6 months, the combination regimens significantly outperformed the standard-of-care, which consists of DARZALEX FASPRO, pomalidomide, and dexamethasone.

Patients treated with the experimental combinations achieved progression-free survival rates of up to 81.3% at 24 months, compared to 51.2% in the standard-of-care group. Overall survival rates reached 89.2% for the Tal-DP arm, versus 79.1% for those receiving the standard regimen. Notably, this study marks the first time a GPRC5D-targeting bispecific antibody has demonstrated superior progression-free survival in earlier-line treatment settings.

Safety profiles remained consistent with known monotherapy data, with the Tal-D arm showing a lower incidence of severe infections than the standard-of-care group. Johnson & Johnson has already submitted a supplemental Biologics License Application to the U.S. Food and Drug Administration and a Type II variation application to the European Medicines Agency to expand access to this treatment regimen.

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