Olaparib benefits early breast cancer patients with BRCA1/2 germline mutation

A first interim analysis of the OlympiA trial demonstrated significantly improved invasive disease-free survival in patients with high-risk, HER2-negative, germline BRCA1/2-mutated primary breast cancer after 1 year of adjuvant treatment with the PARP inhibitor olaparib.

The PARP inhibitor olaparib is licensed for metastatic HER2-negative breast cancer with BRCA1/2 germline mutation (gBRCAm). Even with (neo)adjuvant chemotherapy, recurrence rates in patients with gBRCAm early breast cancer can be high, and novel adjuvant treatments are needed.

The OlympiA trial (NCT02032823) explores the efficacy and safety of adjuvant treatment with olaparib in patients with gBRCAm, high-risk, HER2-negative primary breast cancer. The study enrolled 1,836 patients with gBRCAm and HER2-negative (triple-negative or HR-positive), high-risk, early breast cancer after primary local treatment and adjuvant (49.9%) or neoadjuvant (50.1%) chemotherapy. Patients were randomised 1:1 to receive 1 year of continuous oral olaparib (300 mg twice daily) or placebo. Endocrine therapy and bisphosphonates were allowed. The primary endpoint was invasive disease-free survival in the intention-to-treat population. Secondary endpoints included distant disease-free survival, overall survival, and safety. Prof. Andrew Tutt (Institute of Cancer Research, UK) presented the results of the first interim-analysis of OlympiA at 2.5 years median follow-up [1].

Results showed a significant benefit of olaparib versus placebo regarding invasive disease-free survival (HR 0.58; P<0.0001). Three-year invasive disease-free survival was 85.9% versus 77.1%. Distant disease-free survival was also significantly improved with olaparib (HR 0.57; P<0.0001). Three-year distant disease-free survival was 87.5% versus 80.4%. Overall survival was greater for olaparib than placebo but was not statistically significant at the time of the interim analysis. Three-year overall survival was 92.0% versus 88.3%.

No unexpected adverse events of olaparib were observed. Global Health Quality of Life Score was not significantly affected by treatment with olaparib in patients treated with olaparib after adjuvant chemotherapy nor in patients treated with olaparib after neoadjuvant chemotherapy.

Based on these interim-results, Prof. Tutt concluded that “patients with high-risk, HER2-negative, early breast cancer and germline BRCA1/2 mutations benefit from adjuvant olaparib for 1 year after completion of adjuvant or neoadjuvant chemotherapy.”

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   1. Tutt A, et al. OlympiA: A phase III, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high-risk HER2-negative early breast cancer. Abstract LBA1, ASCO 2021 Virtual Meeting, 4–8 June.

Want to read more? Medicom has a featured interview with Dr Judy Garber (Dana-Farber Cancer Institute, MA, USA) about the OlympiA trial: Adjuvant olaparib extends disease-free survival in BRCA carriers.

Downloadable 1-Page Editor Selected Trial PowerPoint Slide for personal use 

 

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Posted on 12 August, 202115 February, 2024