Pfizer Releases Interim Update On PARP Inhibitor Combo Therapy For Prostate Cancer, Secures FDA Priority Review

Pfizer Inc PFE announced results from the Phase 3 TALAPRO-2 study of Talzenna (talazoparib) in combination with Xtandi (enzalutamide) in 1,106 patients with metastatic castration-resistant prostate cancer (mCRPC).
In an interim Phase III analysis, Xtandi and Talzenna combo reduced risk by 37% compared to Xtandi and placebo in mCRPC patients.
Pfizer previously said the trial met its primary endpoint in October.
The median progression-free survival is 21.9 months for the placebo group, but the treatment arm has yet to reach that point (50% of patients need to have disease progression or death).
In addition, Pfizer said overall survival data are still immature.
Objective response rates, prostate-specific antigen (PSA) response ≥50, time to PSA progression, and subsequent cytotoxic chemotherapy & antineoplastic therapy were significantly improved in Xtandi and Talzenna combo versus placebo plus Xtandi.
The FDA has granted a priority review for the combo treatment for mCRPC.The FDA's decision is expected in 2023.
Price Action: PFE shares are down 0.77% at $42.99 on the last check Thursday.
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