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TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

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Trial Profile

TALAPRO-3: A PHASE 3, RANDOMIZED, DOUBLE-BLIND, STUDY OF TALAZOPARIB WITH ENZALUTAMIDE VERSUS PLACEBO WITH ENZALUTAMIDE IN MEN WITH DDR GENE MUTATED METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2026

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At a glance

  • Drugs Enzalutamide (Primary) ; Talazoparib (Primary)
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms TALAPRO-3
  • Sponsors Pfizer

Most Recent Events

  • 22 Jul 2026 According to a Pfizer media release, company announced that the U.S. Food and Drug Administration (FDA) accepted for Priority Review a supplemental New Drug Application (sNDA) for TALZENNA in metastatic hormone-sensitive prostate cancer (mHSPC), sNDA supported by data from the Phase 3 TALAPRO-3 trial. The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in the last quarter of 2026.
  • 30 May 2026 According to a Pfizer media release, Neeraj Agarwal, M.D. is global lead investigator for TALAPRO-3.
  • 30 May 2026 According to a Pfizer media release, detailed results from the pivotal Phase 3 TALAPRO-3 study presented today in a late-breaking oral presentation (Abstract LBA5007) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine.

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