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.
BRCA1 and BRCA2 are genes that produce proteins responsible for repairing damaged DNA and play an important role in maintaining the genetic stability of cells. When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and certain cells accumulate genetic changes and become unstable. As a result, cells are more likely to develop additional genetic changes that can lead to cancer.
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For early breast cancer involving BRCA 1 and BRCA 2 mutations, treatment with the drug olaparib has been shown to be effective, thanks to a clinical trial run under the Breast International Group (BIG) umbrella
The OlympiA trial, which enrolled a total of 1,836 patients from over 600 hospitals and cancer centres in 23 countries worldwide (including from 21 BIG groups), was set up to test the efficacy and safety of olaparib (Lynparza®) tablets versus placebo as post-surgery treatment to prevent cancer recurrence in patients with BRCA1 and BRCA2, high-risk, HER2-negative early breast cancer who completed surgery and adjuvant (therapy delivered after primary treatment) chemotherapy with previous neoadjuvant (therapy delivered before main treatment) treatment or not.
In 2021, the first encouraging results were presented at ASCO and simultaneously published in the New England Journal of Medicine. Further analyses were performed, and in 2022, the updated results confirmed the benefits already reported the previous year. One year of post-surgery treatment with olaparib, compared to placebo, led to a statistically significant and clinically meaningful improvement in the overall survival of patients, reducing risk of death by 32%.
Following these encouraging results, olaparib was approved by both the European Medicines Agency (EMA) and the U.S Food and Drug Administration (FDA), changing how people with high-risk heredity early breast cancer are treated around the world.
OlympiA is a global collaborative Phase III trial coordinated by the Breast International Group (BIG), 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.