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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Talzenna (talazoparib) (PARP inhibitor, PARP2 inhibitor) + enzalutamide capsule (Androgen receptor inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pfizer Announces Positive TALZENNA® and XTANDI® Combination Data from Phase 3 TALAPRO-2 Study
Published date:
02/16/2023
Excerpt:
In addition, the U.S. Food and Drug Administration (FDA) has granted Priority Review for Pfizer’s supplemental new drug application (sNDA) for TALZENNA in combination with XTANDI for the treatment of men with mCRPC.
Source:
Title:
TALAPRO-2: Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC).
Published date:
02/13/2023
Excerpt:
Objective response rates, PSA response ≥50%, and time to PSA progression and use of subsequent cytotoxic chemotherapy and antineoplastic therapy significantly favored the TALA + ENZA vs PBO + ENZA arm….TALA + ENZA demonstrated statistically significant and clinically meaningful improvement in ibPFS over standard of care ENZA as 1L treatment in pts with mCRPC regardless of HRR status...
DOI:
10.1200/JCO.2023.41.6_suppl.LBA17
Trial ID:
Source:
Title:
Pfizer Announces Positive Topline Results from Phase 3 TALAPRO-2 Trial
Published date:
10/04/2022
Excerpt:
Pfizer Inc. (NYSE: PFE) today announced positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide) compared to placebo plus XTANDI in men with metastatic castration-resistant prostate cancer (mCRPC), with or without homologous recombination repair (HRR) gene mutations. The study met its primary endpoint with a statistically significant and clinically meaningful improvement in radiographic progression-free survival (rPFS) compared with placebo plus XTANDI.
Trial ID:
