Phase III SOLO-1 trial of Lynparza in ovarian cancer published in NEJM.- AstraZeneca + Merck Inc.
AstraZeneca and Merck Inc announced detailed results from the Phase III SOLO-1 trial testing Lynparza (olaparib) 300 mg tablets twice-daily as a maintenance treatment for patients with newly diagnosed advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response following 1st-line standard platinum-based chemotherapy. Results of the trial confirm the statistically significant and clinically meaningful improvement in progression-free survival (PFS) for Lynparza compared to placebo, reducing the risk of disease progression or death by 70%.
With median 41 months of follow-up, the median PFS for patients treated with Lynparza was not reached compared to 13.8 months for patients treated with placebo. Of those receiving Lynparza, 60% remained progression-free at 36 months, compared to 27% of women in the placebo arm. The data were presented at the Presidential Symposium of the ESMO 2018 Congress (European Society for Medical Oncology) in Munich, Germany, and published simultaneously online in the New England Journal of Medicine (NEJM).
See: "Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer" Kathleen Moore et al. NEJM October 21, 2018 DOI: 10.1056/NEJMoa1810858
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