The OlympiA Trial is the Key Study Using Olaparib in Breast Cancer
The OlympiA trial is the name of the pivotal phase III trial evaluating adjuvant olaparib in patients with early-stage, HER2-negative breast cancer with germline BRCA1/2 mutations. 1, 2
Key Features of the OlympiA Trial
- OlympiA was a phase III, double-blind, randomized trial that evaluated the efficacy of adjuvant olaparib in patients with early-stage, HER2-negative breast cancer with high risk of recurrence and germline BRCA1 or BRCA2 mutations 1, 2
- The trial demonstrated that 1 year of adjuvant olaparib following completion of local treatment and (neo)adjuvant chemotherapy significantly improved invasive disease-free survival and distant disease-free survival compared to placebo 1
- At 3 years, invasive disease-free survival was 85.9% in the olaparib group versus 77.1% in the placebo group (HR 0.58; 99.5% CI, 0.41-0.82; P<0.001) 1
- Distant disease-free survival at 3 years was 87.5% in the olaparib group versus 80.4% in the placebo group (HR 0.57; 99.5% CI, 0.39-0.83; P<0.001) 1
Metastatic Setting: OlympiAD Trial
While OlympiA focused on early-stage disease, olaparib was initially studied in metastatic breast cancer in the OlympiAD trial:
- OlympiAD was a phase III trial that randomized patients with germline BRCA-mutated, HER2-negative metastatic breast cancer to olaparib or chemotherapy treatment of physician's choice 1
- The trial showed significantly improved progression-free survival with olaparib (7.0 months) compared to chemotherapy (4.2 months) (HR 0.58; 95% CI, 0.43-0.80; P<0.001) 1, 3
- Benefits were consistent across all subgroups, including hormone receptor status (triple-negative or hormone receptor-positive) and BRCA mutation type (BRCA1 or BRCA2) 3
- Quality of life was significantly better in patients receiving olaparib compared to chemotherapy 4
Clinical Implications
- The OlympiA trial results led to the recommendation that patients with early-stage, HER2-negative breast cancer with germline BRCA1/2 mutations should receive 1 year of adjuvant olaparib after completing standard treatments 1, 2
- For metastatic disease, the OlympiAD trial established olaparib as a preferred treatment option for patients with germline BRCA1/2 mutations and HER2-negative breast cancer 1
- PARP inhibitors (olaparib and talazoparib) are now considered category 1 preferred options for patients with germline BRCA1/2 mutations in the metastatic setting 1
Real-World Evidence
- The phase IIIb LUCY trial confirmed the clinical effectiveness of olaparib in a real-world setting, showing a median progression-free survival of 8.11 months, consistent with the OlympiAD findings 5
- The efficacy of olaparib has been demonstrated across different ethnic populations, including Asian patients 6
The OlympiA trial represents a significant advancement in the treatment of BRCA-mutated breast cancer, establishing the role of PARP inhibition in both early-stage and metastatic disease settings.