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William J. Gradishar, MD, FACP, FASCO
William J. Gradishar, MD, FACP, FASCO
Posted: Monday, March 21, 2022
According to second interim analysis of overall survival from the phase III OlympiA trial, 1 year of adjuvant olaparib led to a statistically and clinically meaningful improvement in the hazard ratio for overall survival of 0.68; this corresponds to a 32% reduction in the risk for death with olaparib versus placebo. These findings were presented during a virtual plenary session of the European Society for Medical Oncology (VP1-2022). This PARP inhibitor improved the survival rates of patients with germline BRCA mutations and high-risk, early-stage breast cancer. Based on these results, the U.S. Food and Drug Administration recently approved this agent in this patient population.
“OlympiA’s latest results are great news for many patients with an inherited form of breast cancer,” stated presenting author Andrew Tutt, PhD, MBChB, of The Institute Cancer Research, London, and King’s College London, in a press release. “It’s an exciting demonstration of the benefits of targeting the specific biology of disease for women with this type of early-stage breast cancer and raises the prospect that more patients will now be cured of their disease.”
Adjuvant use of olaparib reduced the risk of death in patients by 32% compared with a placebo. The study also showed that 1 year of adjuvant olaparib relative to placebo led to improvement of the hazard ratio for overall survival of 0.68 (98.5% confidence interval (CI) = 0.47–0.97; P = .009). At 4 years, the overall survival rate was 89.8% with olaparib versus 86.4% with placebo.
The trial studied 1,836 women with HER2-negative BRCA-mutated breast cancer who had undergone surgery, chemotherapy, hormonal therapies, or radiotherapy where appropriate. Patients randomly received either 300 mg of olaparib twice daily or a placebo. Although the trial will follow participants for a total of 10 years, patients were followed up on after 1 year, and the study reported its first results after 2.5 years following a planned review by an independent monitoring committee.
Disclosure: Disclosures for the study authors can be found at oncologypro.esmo.
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