Lynparza meets primary endpoint in Phase III SOLO-3 trial
AstraZeneca and Merck & Co., Inc., Kenilworth, N.J., US (Merck: known as MSD outside the US and Canada) announced positive results from the randomised, open-label, controlled, Phase III SOLO-3 trial of Lynparza (olaparib) tablets in 266 patients with relapsed ovarian cancer after two or more lines of treatment. The trial was conducted as a post-approval commitment in agreement with the US Food and Drug Administration (FDA). This is the fourth Phase III trial to demonstrate a positive result for Lynparza. AstraZeneca and MSD now plan to discuss these results with the FDA.
Results from the trial showed BRCA-mutated (BRCAm) advanced ovarian cancer patients treated with Lynparza following two or more prior lines of chemotherapy demonstrated a statistically-significant and clinically-meaningful improvement in the primary endpoint of objective response rate (ORR) and the key secondary endpoint of progression-free survival (PFS) compared to chemotherapy. The safety and tolerability profile of Lynparza was consistent with previous trials.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: “We are very excited about SOLO-3, which is the first Phase III trial for a PARP inhibitor to demonstrate a positive result versus chemotherapy in advanced ovarian cancer where effective options are needed. We look forward to sharing the full results at a forthcoming medical meeting.”
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Following on the US approval of Lynparza as first-line maintenance therapy for certain patients with BRCAm advanced ovarian cancer, the results of SOLO-3 further reinforce the efficacy of Lynparza in relapsed patients with gBRCAm advanced ovarian cancer following multiple lines of chemotherapy.”