Pfizer’s Talzenna in combination with Xtandi received the US FDA approval for mCRPC

CAR-T Digest - August 2020

20 Jun 2023: Talzenna (Talazoparib) / Xtandi (Enzalutamide) / mCRPC / Pfizer: Received US FDA approval

This approval was based on the positive data from the Phase 3 TALAPRO-2 study of Talazoparib + Enzalutamide for the treatment of HRR gene-mutated mCRPC patients
Efficacy:
- The combination of Talazoparib + Enzalutamide showed a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C)
- A trend in OS favoring the combination was also observed, though the data are immature
- The final OS data will be reported once the predefined number of survival events has been reached
  - Final OS data is anticipated in 2024
- If positive, the data may be used to support a potential regulatory filing to benefit broader patient populations
Safety:
- Safety profile was generally consistent with the known safety profile of each medicine
- SAEs occurred in 30% of patients treated with Talazoparib + Enzalutamide
- SAEs reported in >2% of patients included anemia (9%) and fracture (3%)
- Discontinuation of TALZENNA occurred in 10% of patients
The results from Cohort 1 were previously reported and published in “The Lancet”