OlympiA is a randomized, double-blind, parallel group, placebo-controlled multi-center phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. This international study is sponsored by AstraZeneca and NRG oncology and is coordinated by the Breast International Group (BIG). Frontier Science provides project management; statistical leadership, design and analysis; randomization; data management; and programming. A separate firewalled Frontier Science statistical unit provided independent statistical analysis for the Data Monitoring until the data was unblinded at the first Interim Analysis.
The results of the first interim analysis of IDFS were presented at the ASCO plenary in 2021 and published in the New England Journal of Medicine.. The results showed olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death.
The results of the second interim analysis of overall survival also showed olaparib demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), leading to FDA approval for the adjuvant treatment of patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer. This data was presented at ESMO plenary in March 2022. The manuscript preparation is ongoing. Blinded follow-up continues.
PUBLICATIONS ABOUT OlympiA
The consistency of results between the subset of patients from Japan and the global OlympiA population supports the clinical benefit of adjuvant olaparib for patients with gBRCA1/2pv and HER2-negative, high-risk eBC in Japan after completion of local treatment and neoadjuvant or adjuvant CT.
OlympiA demonstrates statistically significant improvement in overall survival with adjuvant olaparib compared with placebo
Pre-specified event driven analysis of Overall Survival (OS) in the OlympiA phase III trial of adjuvant olaparib (OL) in germline BRCA1/2 mutation (gBRCAm) associated breast cancer