AstraZeneca’s Lynparza tablets against BRCA-mutatedovarian cancer have shown positive results from the Phase III SOLO-2 trial, the company said on Wednesday.
According to AstraZeneca, the results from the trial have demonstrated a clinically-meaningful and statistically-significant improvement of progression-free survival (PFS) among patients treated with Lynparza compared to placebo and provided additional evidence to support the potential use of Lynparza in this patient population.
Furthermore, 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 (Study 19), the company has revealed.
Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: “We are pleased with the robust improvement in progression-free survival demonstrated by Lynparza in the SOLO-2 trial. 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.”
Initial findings have shown that safety profile with Lynparza tablets was consistent with previous studies. The company will present full results of SOLO-2 at next medical meeting.
In conclusion, the company has added that these positive results follow the Fast Track Designation for Lynparza by the US FDA earlier this year, in patients with a BRCA mutation who have platinum-sensitive, relapsed ovarian cancer.