LYNPARZA (olaparib) Significantly Delays Disease Progression in Phase 3 First-Line SOLO-1 Trial for Ovarian Cancer

AstraZeneca and Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced positive results from the randomized, double-blinded, placebo-controlled, Phase 3 SOLO-1 trial of LYNPARZA (olaparib) tablets.

As quoted in the press release:

Women with BRCA-mutated (BRCAm) advanced ovarian cancer treated first-line with LYNPARZA maintenance therapy had a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo. The safety and tolerability profile of LYNPARZA was consistent with previous trials. Based upon these data, AstraZeneca and Merck plan to initiate discussions with health authorities regarding regulatory submissions.

Sean Bohen, executive vice president, global medicines development and chief medical officer at AstraZeneca, said, “For the first time, we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor. 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. We would like to thank the investigators, hospitals and most of all the patients who took part in this trial, without whom medical advancements would not be possible.”

Click here to read the full press release.