In the OlympiAD study, olapani was shown to improve progressive survival metastatic breast cancer (mBC) compared to chemotherapy with a reproductive BRCA1 and/or BRCA2 mutation (BRCAAm) and a human epidermal growth factor receptor 2 (HER2) negative chemotherapy (TPC)Now, we report the program's final overall survival (OS) results and describe the most common adverse events (AE) to better understand the population's tolerance to olaparib
OlympiAD is a Phase III randomized, controlled, open-label study (NCT020006222) in patients with BRCAm reproductive and HER2-negative mBC lines who received mBC chemotherapy with a line of 2Patients were randomly divided into olapani tablets (300 mg bid) or pre-announced TPC (Capitabin, Changchun Rybin or Ayrebrin)OS and security are secondary endpoints
Results A total of 205 patients were randomly assigned to olaparib and 97 were randomly assigned to TPCAt 64% of the data maturity, Olapani's median OS was 19.3 months, while the median OS for TPC was 17.1 months (HR 0.90, 95%CI 0.66-1.23; P - 0.513); In a pre-specified subgroup, HR using olaparib and TPC for OS is: past mBC chemotherapy (no (first-line treatment): 0.51, 95% CI 0.29-0.90; (Triple negative: 0.93, 0.62-1.43; hormone receptor-positive: 0.86, 0.55-1.36); previous platinum (yes: 0.83, 0.49-1.45; No: 0.91, 0.64-1.33)Adverse events during olapani treatment are usually low and can be controlled by supporting treatment or dose adjustmentThe discontinuation rate is very low (4.9%) and long-term use of olapani does not increase the risk of anaemia
Overall, the results suggest that, while OS did not show statistically significant improvement compared to TPC, OS may have a meaningful OS benefit in patients who did not receive chemotherapy for metastatic diseaseOlaparib is generally well tolerated and there is no evidence of cumulative toxicity from prolonged exposure
