AstraZeneca (LON: AZN) and its global biologics research and development arm, MedImmune, have recorded positive results in the Phase III PACIFIC trial, the company announced on Friday.
The Phase III Pacific trial was a randomised, double-blind, placebo-controlled, multi-centre study involving Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT). The data revealed positive overall survival (OS) results.
An Independent Data Monitoring Committee conducted a planned interim analysis and concluded that the trial had met its second of two primary endpoints by showing statistically-significant OS benefit with clinically-meaningful improvement in patients receiving Imfinzi compared to placebo.
Safety and tolerability for Imfinzi was found to be consistent with the profile reported in the progression-free survival (PFS) analysis. AstraZeneca plans to present these results at an upcoming medical meeting.
Imfinzi is currently approved as a treatment for patients with unresectable Stage III NSCLC who had not progressed following platinum-based chemoradiation therapy in the US and Canada. It is currently under regulatory review in the EU, Japan and other jurisdictions for this indication, with decisions expected in the second half of 2018.
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