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Pfizer reports that the combination of talazoparib and enzalutamide demonstrated statistically significant improvement in patient survival in a Phase III trial.
Pfizer announced positive results from its Phase III study (TALAPRO-2) of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) on Feb. 16, 2023. The combination treatment was found to demonstrate a statistically significant improvement in radiographic progression-free survival (rPFS) compared to placebo in men with metastatic castration-resistant prostate cancer (mCRPC). FDA has granted the treatment a priority review status.
According to a company press release, the combination treatment reduced the risk of disease progression or death by 37% relative to placebo plus enzalutamide.These findings held independent of the presence of homologous recombination repair (HRR) gene mutations. Preliminary results found that overall survival rate also favored the treatment, but these results were immature at the time of the announcement.
“Novel hormone therapies dramatically changed outcomes for patients with mCRPC in the last decade, and the results from the TALAPRO-2 study show that the addition of talazoparib to the existing standard of care adds significant clinical benefit,” said Neeraj Agarwal, professor of Oncology and presidential endowed chair of Cancer Research at Huntsman Cancer Institute, University of Utah, and lead investigator for TALAPRO-2, in the release. “In addition to delaying disease progression, this combination delayed prostate-specific antigen progression and time to chemotherapy without adversely impacting patient quality of life. The TALAPRO-2 results support the potential for this combination to be practice-changing, with strong, highly consistent efficacy and observations in mCRPC patients both with or without HRR gene mutations, and across clinically relevant sub-populations.”
“Patients with mCRPC need new treatment approaches that can improve outcomes, and the rPFS results from TALAPRO-2, which appears to be the longest observed in a randomized trial in this setting, demonstrate the potential of the [talazoparib] and [enzalutamide] combination, if approved, to become a new standard of care,” said Chris Boshoff, chief development officer, Oncology and Rare Disease, Pfizer Global Product Development, in the release. “We are pleased that the FDA has granted [p]riority [r]eview for our application, and we look forward to working with the [a]gency and global regulatory authorities to bring this treatment to men with mCRPC.”