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16 Feb 2023: Talazoparib + Enzalutamide (Oral) / Pfizer: Positive data from TALAPRO-2 trial for 1L mCRPC; Priority review from US FDA granted
Summary:
- Initial data show 37% reduction in risk of disease progression or death in mCRPC patients treated with Talazoparib + Enzalutamide versus Enzalutamide
- Based on imaging, PFS was 54% better in HRR–deficient patients for the Talazoparib + Enzalutamide vs placebo + Enzalutamide arm
- It is 30% better in HRR–non-deficient tumors or tumors without a known HRR status (based on imaging), and was 34% better based on tumor tissue testing
- Results showed a trend toward improved overall survival, a key secondary endpoint, at the time of the analysis, but the data are not yet mature
CI Scientists Commentary:
- TALAPRO-2 showed the longest observed rPFS in a randomized trial in 1L mCRPC setting
- Given the comparable results to Lynparza + Abiraterone combination, Talazoparib + Enzalutamide will likely receive an “all-comer” label in the US and EU
