AstraZeneca PLC said Wednesday that an independent committee has concluded the Phase 3 OlympiA trial of its early breast cancer treatment, Lynparza, will be analyzed and reported early.
The British pharmaceutical giant said the independent data monitoring committee has concluded that Lynparza has crossed the superiority boundary for it primary endpoint of invasive disease-free survival, outperforming placebos. The Phase 3 trial will now move to early primary analysis and reporting.
The drug targets mutations in the BRCA1 and BRCA2 genes, the most common cause of hereditary breast cancer–itself the most common cancer in the world for women. Around 2.3 million women were diagnosed with breast cancer world-wide in 2020, and up to 65% of women with a BRCA1 mutation and around 45% of women with a BRCA2 mutation will develop breast cancer before the age of 70.
The independent data monitoring committee didn’t raise any additional concerns and the trial will continue to assess key secondary endpoints of overall survival and distant disease-free survival, AstraZeneca said.
The OlympiA Phase 3 trial is a partnership between Breast International Group, NRG Oncology, the US National Cancer Institute, Frontier Science & Technology Research Foundation, AstraZeneca and Merck & Co., Inc.
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