AstraZeneca and Merck today presented data from the Phase 3 OlympiAD trial showing the final overall survival (OS) results for Lynparza in metastatic breast cancer. The trial compared Lynparza with chemotherapy (physician’s choice of capecitabine, eribulin or vinorelbine) for patients with germline BRCA-mutated (gBRCAm), HER2-negative metastatic breast cancer and met its primary endpoint of progression-free survival (PFS).
Results at AACR include updated findings from the secondary endpoint of overall survival (OS). While the trial was not powered to demonstrate a statistically significant difference, the median OS was 19.3 months in patients treated with Lynparza and 17.1 months for patients treated with chemotherapy (HR 0.90, 95% CI 0.66-1.23; p=0.513). At the final OS data cutoff (64% maturity), 13 percent of patients remained on Lynparza and no patients remained on chemotherapy.
Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, “OlympiAD is the first Phase 3 trial to demonstrate disease control with a PARP inhibitor in gBRCA-mutated, HER2-negative metastatic breast cancer. While the trial was not powered to show overall survival compared to chemotherapy, the results are another encouraging factor in the use of Lynparza for this patient population.”
When analyzing the predefined subgroups, the results were consistent with the overall analysis, which did not show a statistically significant difference between arms. The greatest difference was seen in patients who had not received chemotherapy in the metastatic setting with a median difference in OS of 7.9 months with Lynparza (HR 0.51, 95% CI 0.29-0.90; nominal p=0.02; median 22.6 vs 14.7 months).