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New Indication: Talazoparib + enzalutamide first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC)

New Indication: Talazoparib + enzalutamide first-line treatment for patients with metastatic castration-resistant prostate cancer (mCRPC)
Study:
  • Double-blind, placebo-controlled phase 3 trial (TALAPRO-2)
  • Previously untreated, CRPC
  • Enzalutamide + talazoparib (n=402) vs. Enzalutamide + PBO (n=403)
Efficacy:
    ITT:
  • mrPFS: NR [27.5 mos-NR] vs 21.9 mos, HR:0.63, p<0.0001
    • HRRm subgroup
  • mrPFS: 27.9 vs 16.4 mos, HR:0.45, p=0.0003
    • HRR non-deficient or unknown subgroup
  • mrPFS: NR [27.5 vs NR] vs 22.5 mos, HR:0.70, p=0.003
Safety:
  • Grade≥3 AEs: Anemia (15.1% vs 3.3%), hypertension (3.5% vs 3.3%), venous emboli and thrombosis (6.8% vs 2.0%)

Lancet Oncol 04 JUN, 2023

Agarwal Neeraj et al. Talazoparib plus enzalutamide in men with first-line metastatic castration-resistant prostate cancer (TALAPRO-2): a randomized, placebo-controlled, phase 3 trial.

http://doi.org/10.1016/S0140-6736(23)01055-3

Reviewed by Elvin CHALABİYEV, MD on JUL 10, 2023

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