SOLO-1 Phase III trial demonstrates Lynparza potential in ovarian cancer

AstraZeneca (LSE: AZN) and partner Merck & Co (NYSE: MRK) announced detailed results from the Phase III SOLO-1 trial testing Lynparza(olaparib) tablets as a maintenance treatment for patients with newly-diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response following first-line standard platinum-based chemotherapy at the European Society for Medical Oncology (ESMO) meeting now taking place in Munich, Germany.

Results of the trial confirm the statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for Lynparzacompared to placebo, reducing the risk of disease progression or death by 70% (HR 0.30 [95% CI 0.23-0.41], p<0.001). At 41 months of follow-up, the median PFS for patients treated with Lynparzawas 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.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said: “There is currently a significant unmet need in the treatment of advanced ovarian cancer because 70% of women relapse within the first three years after their initial treatment. The remarkable results of the SOLO-1 trial, which showed that 60% of women with newly-diagnosed, advanced BRCA-mutated ovarian cancer remained progression-free at three years, highlight the potential of Lynparzaas a maintenance therapy in the 1st-line setting.”