OlympiA Phase III Results titled “Adjuvant Olaparib for Patients with BRCA1- or BRCA2-Mutated Breast Cancer” were published in the June 3, 2021 edition of The New England Journal of Medicine.
Results of this analysis will also be presented during the plenary session of the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting (abstract LBA#1). The results were made available by ASCO on 3rd June and simultaneously published in The New England Journal of Medicine prior to their presentation in the plenary session. An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020, and BRCA1 and BRCA2 mutations are found in approximately 5% of breast cancer patients.
From the researchers’ press release dated June 3, 2021, “Results from the OlympiA Phase III trial showed olaparib (Lynparza) demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of patients with germline BRCAmutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Upon review of the planned interim analysis in February 2021, the IDMC concluded that the trial had crossed the superiority boundary for its primary endpoint and recommended for the OlympiA trial to move early to primary analysis and reporting.”
OlympiA is a global collaborative Phase III trial coordinated by the Breast International Group (BIG) worldwide, in partnership with NRG Oncology, the US National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and MSD. The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.
Four Frontier Science offices were involved in the OlympiA study: data management and database programming (Frontier Science Amherst, NY, and Frontier Science Scotland in Kincraig), Independent Statistical Center (Frontier Science Madison, WI), statistics and statistical programming (Frontier Science Scotland and Frontier Science Boston, MA).
Reference: A.N.J. Tutt, J.E. Garber, B. Kaufman, G. Viale, D. Fumagalli, P. Rastogi, R.D. Gelber, E. de Azambuja, A. Fielding, J. Balmaña, S.M. Domchek, K.A. Gelmon, S.J. Hollingsworth, L.A. Korde, B. Linderholm, H. Bandos, E. Senkus, J.M. Suga, Z. Shao, A.W. Pippas, Z. Nowecki, T. Huzarski, P.A. Ganz, P.C. Lucas, N. Baker, S. Loibl, R. McConnell, M. Piccart, R. Schmutzler, G.G. Steger, J.P. Costantino, A. Arahmani, N. Wolmark, E. McFadden, V. Karantza, S.R. Lakhani, G. Yothers, C. Campbell, and C.E. Geyer, Jr., for the OlympiA Clinical Trial Steering Committee and Investigators; June 3, 2021 DOI: 10.1056/NEJMoa2105215