A twice-daily dose of AstraZeneca's Lynparza held off progression of ovarian cancer in certain patients when used as a maintenance treatment during a late-stage trial.
Data from the Phase III SOLO-2 trial demonstrate "a clinically-meaningful and statistically-significant improvement" of progression-free survival (PFS) among patients with platinum-sensitive relapsed, BRCA-mutated ovarian cancer taking the drug as monotherapy compared to placebo.
The median PFS in the Lynparza (olaparib) arm of SOLO-2 "substantially exceeded that observed in the Phase II maintenance study", the firm noted, lending further weight to its use in this patient population.
The drug also fared well on the safety side, with initial findings showing a safety profile consistent with that seen in previous studies.
Sean Bohen, AZ' chief medical officer, said the firm will now work regulatory authorities to make Lynparza tablets available as quickly as possible in this setting, and that it remains "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."
Full results of SOLO-2 are to be presented at a forthcoming medical meeting.
Ovarian cancer is a serious and life-threatening condition causing more than 4,000 deaths in the UK each year. Up to 21 percent with the most aggressive form of ovarian cancer have the genetic BRCA mutation.
Lynparza is already approved on both sides of the Atlantic to treat women with BRCAm ovarian cancer.