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After a median follow-up of 6.1 years, olaparib continued to demonstrate improved invasive disease-free survival (IDFS), distant disease-free survival (DDFS), and overall survival (OS) in patients with high-risk BRCA1/2-mutated, HER2-negative breast cancer (BC) compared with placebo, according to the results of the OlympiA trial.
Data from the third pre-specified interim analysis of the OlympiA trial (NCT02032823) were presented by Judy Garber, MD, MPH, from the Dana-Farber Cancer Institute, Massachusetts1. “The rationale for the OlympiA trial is based on the observation that inhibiting and trapping PARP1 on DNA—in this trial with the PARP inhibitor olaparib—leads to synthetic lethality due to the loss of function of BRCA1/2 proteins and loss of homologous recombination DNA repair,” said Dr. Garber. The trial included oestrogen (ER)-positive and triple-negative breast cancer (TNBC) patients with pathogenic germline BRCA1/2 (n=1,836), evaluating 1 year of adjuvant olaparib after standard treatment. The first pre-specified interim analysis of the OlympiA trial showed significant improvements in IDFS and DDFS with Olaparib. In contrast the second pre-specified interim analysis demonstrated significant improvement in OS.
The latest results of the third pre-specified analysis at a median follow-up of 6.1 years confirm the long-term benefit of olaparib across all key subgroups. Olaparib continued to improve IDFS (stratified HR 0.65; 95% CI 0.53–0.78), DDFS (stratified HR 0.65; 95% CI 0.53–0.81), and OS (stratified HR 0.72; 95% CI 0.56–0.93). Fewer AEs were observed in the olaparib arm compared with the placebo arm, and the incidence of myelodysplastic syndrome and acute myeloid leukemia remained low.
In conclusion, the ongoing data continue to support the use of adjuvant olaparib as the standard of care for patients with germline BRCA pathogenic variants and high-risk HER2-negative breast cancer. Moreover, the data highlight the need to identify patients who could benefit from olaparib early in treatment, allowing it to be introduced at the most optimal time in their treatment plan. There will be a blinded follow-up for the final planned analysis in June 2029.
Medical writing support was provided by Kulsoom Abdul.
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