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Pfizer Reports Positive Topline Results From Phase 3 TALZENNA Trial

Pfizer Inc. (PFE) announced Tuesday positive topline results from the Phase 3 TALAPRO-2 study of TALZENNA (talazoparib) plus XTANDI in men with metastatic castration-resistant prostate cancer or mCRPC.

The trial evaluated TALZENNA, an oral poly ADP-ribose polymerase or PARP inhibitor, in combination with XTANDI (enzalutamide) compared to placebo plus XTANDI in men with 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 or rPFS compared with placebo plus XTANDI.

The company noted that the results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but these data are not yet mature.

At the time of topline analysis, the safety of TALZENNA plus XTANDI were generally consistent with the known safety profile of each medicine.

XTANDI is a global standard of care, with overall survival demonstrated in mCRPC, non-metastatic CRPC, and metastatic castration-sensitive prostate cancer.

Chris Boshoff, Chief Development Officer, Oncology and Rare Disease, Pfizer Global Product Development, said, "These data highlight the potential for TALZENNA in combination with XTANDI, if approved, to become a new standard of care for mCRPC, irrespective of HRR gene mutation status."

The company will submit detailed results from TALAPRO-2 for presentation at a near-term medical congress. The data will also be shared with global regulatory authorities to potentially support a regulatory filing.

TALZENNA or the combination of TALZENNA plus XTANDI have not been approved by any regulatory agency for the treatment of mCRPC.

In addition to the TALAPRO-2 trial, the combination of TALZENNA plus XTANDI is being investigated in the TALAPRO-3 trial (NCT04821622), a global, randomized, double-blind, placebo-controlled Phase 3 study in men with HRR-deficient mCSPC.

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