#Lyn us trial#
Professor Andrew Tutt, Global Chair of the OlympiA Phase III trial and Professor of Oncology at The Institute of Cancer Research, London and King’s College London, said: “Today’s approval of olaparib is great news for patients with a specific inherited form of breast cancer.
2 Almost 91% of all breast cancer patients in the US are diagnosed at an early stage of disease and BRCA mutations are found in approximately 5-10% of patients. The OS data will be presented at an upcoming European Society for Medical Oncology virtual plenary on 16 March 2022.īreast cancer is the most diagnosed cancer worldwide with an estimated 2.3 million patients diagnosed in 2020. The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials.
New updated results from the OlympiA trial also showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), reducing the risk of death by 32% versus placebo (based on a HR of 0.68 95% CI 0.50-0.91 p=0.0091). In the trial, Lynparza 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, by 42% versus placebo (based on a hazard ratio of 0.58 95% confidence interval 0.46-0.74 p<0.0001). The approval by the US Food and Drug Administration (FDA) was based on results from the OlympiA Phase III trial presented during the 2021 American Society of Clinical Oncology Annual Meeting and published in The New England Journal of Medicine. Partnerships, alliances and recognitionĪstraZeneca and MSD’s Lynparza (olaparib) has been approved in the US for the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
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