P1.01A phase 3 study of the oral PARP inhibitor talazoparib (BMN 673) in BRCA mutation subjects with advanced breast cancer (EMBRACA).

Background: Poly-ADP-ribose polymerase (PARP) enzymes are important in DNA repair. PARP inhibition induces lethality in tumor cells with mutations in the genes encoding breast cancer susceptibility gene 1 (BRCA1) and breast cancer susceptibility gene 2 (BRCA2). Talazoparib (BMN 673) is a novel, dual-mechanism PARP inhibitor that both potently inhibits the PARP enzyme and effectively traps PARP on DNA, resulting in cell death in BRCA1/2-mutated cells.[1, 2] Talazoparib has shown promising single-agent antitumor efficacy in several solid tumor types and generally well tolerated in an ongoing Phase 1/2 clinical study[3].