Positive results from SOLO-3 trial of Lynparza for BRCA-mutated advanced ovarian cancer patients.-AstraZeneca

AstraZeneca and Merck & Co., Inc., 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 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.

About SOLO-3: SOLO-3 is a Phase III randomised, open-label, controlled, multicentre trial to evaluate the efficacy and safety of Lynparza tablets following two or more prior lines of chemotherapy. The trial randomised 266 patients with a deleterious or suspected deleterious BRCA1 or BRCA2 mutation. Eligible patients were randomised (2:1) to receive Lynparza 300mg tablets twice daily or physician�s choice single-agent chemotherapy (paclitaxel, topotecan, pegylated liposomal doxorubicin or gemcitabine). The primary endpoint was ORR by blinded independent central review and key secondary endpoints included progression-free survival, time to second disease progression or death and overall survival.