J&J says Phase 3 MonumenTAL-3 trial shows Talvey-Darzalex Faspro combo boosts progression-free survival in relapsed multiple myeloma
Johnson & Johnson
Johnson & Johnson JNJ | 0.00 |
- Johnson & Johnson disclosed Phase 3 MonumenTAL-3 results already presented at the 2026 EHA meeting, with simultaneous publication in The New England Journal of Medicine.
- The TALVEY and DARZALEX FASPRO combinations, with or without pomalidomide, delayed disease worsening and extended survival versus a standard daratumumab-based regimen.
- Results support moving the GPRC5D-targeting bispecific approach into earlier relapsed or refractory multiple myeloma treatment, a potential expansion of addressable use.
- Safety was broadly consistent with known profiles; severe infections were lower in the two-drug arm, while cytokine release syndrome was mostly low grade.
- Regulatory filings were submitted to the FDA and EMA seeking use of the combination after at least one prior line of therapy.
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