TALVEY (talquetamab-tgvs) plus DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) - (MonumenTAL-6)
- Indication
- Relapsed/refractory multiple myeloma, CD38 exposed
- Stage
- phase3
- Event
- End of Phase Meeting
- Details
July 23, 2026: Johnson & Johnson (NYSE: JNJ) reported positive topline results from the three-arm, investigational Phase 3 MonumenTAL-6 trial (NCT06208150) in adults with relapsed/refractory multiple myeloma who had received 1–4 prior lines of therapy including an anti-CD38 antibody and lenalidomide. The study compared TECVAYLI (teclistamab-cqyv) + TALVEY (talquetamab-tgvs) (Tec‑Tal) and TALVEY + pomalidomide (Tal‑P) versus investigator’s choice standard of care (EPd or PVd).
Both investigational arms met the primary endpoint, improving progression-free survival versus standard of care. Tec‑Tal reduced risk of progression or death by 89% (HR 0.11; 95% CI 0.08–0.16; p<0.0001); Tal‑P reduced risk by 73% (HR 0.27; 95% CI 0.2–0.35). The company also stated overall survival improved for both investigational arms; Tec‑Tal reduced risk of death by 62% (HR 0.38).
Safety was described as consistent with known monotherapy profiles. The IDMC recommended unblinding at the first interim analysis. Full results are planned for a future major medical meeting and will be shared with global health authorities.
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