Phase 3 study of adjuvant olaparib for BRCA1- or BRCA2-mutated breast cancer

The multinational phase 3 study OlympiA randomized patients with HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants after completion of local treatment and neoadjuvant or adjuvant chemotherapy to adjuvant olaparib or placebo. The 3-year invasive disease-free survival was 85.9% in the olaparib group and 77.1% in the placebo group (HR 0.58; p<0.001), and the 3-year distant disease-free survival was 87.5% in the olaparib group and 80.4% in the placebo group (HR 0.57; p<0.001). Olaparib was associated with fewer deaths than placebo (HR 0.68; p=0.02). Safety data were consistent with known side effects of olaparib, with no excess serious adverse events.