It showed a clinically-meaningful and statistically-significant improvement of PFS among patients treated with Lynparza compared to placebo.
AstraZeneca said 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.
Initial findings show safety profile with Lynparza tablets was consistent with earlier studies. The company will present full results of SOLO-2 at a forthcoming medical meeting.
AstraZeneca executive vice president for global medicines development and chief medical officer Sean Bohen said: “We will work with regulatory authorities to make Lynparza tablets available as quickly as possible to patients with ovarian cancer.
“We remain committed to investigating the full potential of Lynparza, both as monotherapy and in combinations, and to identifying all patients who may benefit from this important medicine.”
Earlier this year, the US Food and Drug Administration granted Lynparza fast track designation in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.
Lynparza is an oral poly ADP-ribose polymerase inhibitor that could exploit tumour DNA damage response pathway deficiencies to preferentially kill cancer cells.
Regulatory authorities in the European Union and US approved it to treat women with BRCAm ovarian cancer.
Image: Lynparza Phase III SOLO-2 trial shows significant progression-free survival benefit. Photo: courtesy of AstraZeneca.