AstraZeneca and MSD have announced that the European Commission (EC) has approved Lynparza (olaparib) as a 1st-line maintenance treatment for women with BRCA-mutated advanced ovarian cancer.
The approval was based on data from the pivotal Phase III SOLO-1 trial which tested Lynparza as maintenance monotherapy compared with placebo in patients with BRCAm advanced ovarian cancer following 1st-line platinum-based chemotherapy. In SOLO-1, Lynparza demonstrated clinically-meaningful results with a 70% reduction in the risk of disease progression or death.
At 40.7 months of follow-up, the results showed the median time of progression for patients treated with Lynparza had not yet been reached vs. 13.8 months for those on placebo.
The licensed indication is specifically as a maintenance treatment of adult patients with FIGO stages III and IV BRCA1/2-mutated high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response, following completion of 1st-line platinum-based chemotherapy.
This is the third indication for Lynparza in the EU. AstraZeneca and MSD are exploring additional trials in ovarian cancer, including the ongoing Phase III PAOLA-1 trial, which is testing Lynparza in combination with bevacizumab as a 1st-line maintenance treatment for women with newly-diagnosed, advanced, stage IIIB-IV high grade serous or endometrioid ovarian cancer, regardless of BRCA status.
Dave Fredrickson, executive vice president, AZ Oncology Business Unit, said: “This approval sets the stage for a new standard of care in the EU for women with ovarian cancer and a BRCA mutation. The goals of front-line therapy have always been long-term remission and even cure, yet currently 70% of patients relapse within three years of initial treatment. The progression-free survival benefit of Lynparza observed in SOLO-1 represents a major step forward in our ambition to help transform patient outcomes.”
The data were presented on 21 October 2018, at the Presidential Symposium of the ESMO (European Society for Medical Oncology) 2018 Congress in Munich, Germany and published simultaneously online in The New England Journal of Medicine.