AstraZeneca and Merck’s Phase III SOLO-1 trial of Lynparza (olaparib) tablets, for women with BRCA-mutated (BRCAm) advanced ovarian cancer treated 1st-line with Lynparza maintenance therapy, brought good results.
According to the press release the drugmakers issued Wednesday, these women had a statistically-significant and clinically-meaningful improvement in progression-free survival compared to placebo. The safety and tolerability profile of Lynparza was consistent with previous trials. Based upon these data, AstraZeneca and MSD plan to initiate discussions with health authorities regarding regulatory submissions, the companies said.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said that there was seen a significant and clinically-impactful improvement in progression-free survival in the 1st-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor for the first time. He said that the SOLO-1 data reinforce the importance of knowing BRCA status at diagnosis, as this may enable women with BRCA-mutated ovarian cancer to receive Lynparza earlier.
Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Building on the strong data we’ve seen with Lynparza to date, the data from SOLO-1 reinforces Lynparza’s ability to provide meaningful disease control with a well-characterised safety and tolerability profile. We look forward to presenting the full data set for SOLO-1 at a future medical meeting and working with regulatory authorities to bring Lynparza to women with ovarian cancer in the 1st-line maintenance setting as quickly as possible.”