Phase III SOLO-2 trial of Lynparza (olaparib) shows PFS improvement in ovarian cancer- AstraZeneca

AstraZeneca announced positive results from the Phase III SOLO-2 trial designed to determine the efficacy of Lynparza (olaparib) tablets (300mg twice daily) as a monotherapy for the maintenance treatment of platinum-sensitive relapsed, BRCA-mutated ovarian cancer.

Results from the trial demonstrate a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo and provide additional evidence to support the potential use of Lynparza in this patient population. Importantly, the median PFS in the Lynparza arm of SOLO-2 substantially exceeded that observed in the Phase II maintenance study in patients with platinum-sensitive relapsed ovarian cancer (Study 19). Initial findings demonstrate that safety profile with Lynparza tablets was consistent with previous studies.

Full results of SOLO-2 will be presented at a forthcoming medical meeting. These positive results follow the Fast Track Designation for Lynparza by the US FDA earlier this year, in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.

Comment: The National Institute for Health and Care Excellence (NICE) now recommends Lynparza (olaparib) from AstraZeneca to treat patients with BRCA mutation positive ovarian cancer. This is a reversal of an earlier decision after AstraZeneca supplied further evidence. The recommendation applies to maintenance treatment for patients with relapsed platinum-sensitive ovarian, fallopian tube or peritoneal cancers who have BRCA1 or BRCA2 mutations and whose disease has responded to platinum-based chemotherapy.