AstraZeneca (UK) and MedImmune (MD, USA) have announced results of their Phase III PACIFIC trial. The findings demonstrate that Imfinzi® (durvalumab) improves overall survival (OS) 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), compared with placebo.
The company states that durvalumab met the second primary endpoint of OS, which was both statistically-significant and clinically-meaningful at a planned interim analysis.
The PACIFIC trial is a randomized, double-blinded, placebo-controlled, multi-center trial of durvalumab as treatment in patients with Stage III unresectable NSCLC whose disease has not progressed following platinum-based CRT.
The trial is being conducted in 235 centers across 26 countries, involving 713 patients. The primary endpoints of the trial are PFS and OS, and secondary endpoints include landmark progression-free survival (PFS) and OS, overall response rate and duration of response.
The safety and tolerability profile for durvalumabwas consistent with that reported at the time of the PFS analysis.
“The readout of positive overall survival data at the interim analysis of the PACIFIC trial provides additional compelling evidence of the clinical benefit that Imfinzi can offer patients in this earlier stage of lung cancer,” explained Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca.
In May 2017, AstraZeneca announced that the PACIFIC trial met its first primary endpoint of PFS by demonstrating a median improvement of 11.2 months vs. placebo, as assessed by blinded independent central review.
AstraZeneca plans to present results from the PACIFIC trial at a forthcoming medical meeting. Imfinzi is currently approved in the US and Canada for the treatment of patients with unresectable Stage III NSCLC who had not progressed following platinum-based CRT and under regulatory review in the EU, Japan and other jurisdictions with expected decisions in the second half of 2018.