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Association details:
| Biomarker: | No biomarker |
|---|---|
| Cancer: | Prostate Cancer |
| Drug: | Talzenna (talazoparib) (PARP inhibitor) + Xtandi (enzalutamide capsule) (Androgen receptor inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Pfizer’s TALZENNA® in Combination with XTANDI® Receives CHMP Positive Opinion in the European Union for Adult Patients with Metastatic Castration-Resistant Prostate Cancer
Published date:
11/13/2023
Excerpt:
Pfizer...announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion for TALZENNA® (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI® (enzalutamide), for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) in whom chemotherapy is not clinically indicated....The CHMP positive opinion is supported by results from the Phase 3 TALAPRO-2 trial...
Source:
Title:
Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomised, placebo-controlled, phase 3 trial
Published date:
06/08/2023
Excerpt:
Median follow-up for rPFS was 24·9 months (IQR 21·9-30·2) for the talazoparib group and 24·6 months (14·4-30·2) for the placebo group. At the planned primary analysis, median rPFS was not reached (95% CI 27·5 months-not reached) for talazoparib plus enzalutamide and 21·9 months (16·6-25·1) for placebo plus enzalutamide (hazard ratio 0·63; 95% CI 0·51-0·78; p<0·0001).
DOI:
10.1016/S0140-6736(23)01055-3
Trial ID:
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:
