AstraZeneca and MedImmune, its global biologics research and development arm, on Friday reported positive overall survival (OS) results for the Phase III PACIFIC trial, a randomised, double-blinded, placebo-controlled, multi-centre trial of Imfinzi in patients with unresectable Stage III non-small cell lung cancer (NSCLC).
This test was specific for the patients whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT), AZ explained.
Sean Bohen, Chief Medical Officer at AstraZeneca, said that 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. We look forward to sharing these results with Health Authorities to support ongoing regulatory interactions and to update the Imfinzi label with these important data.”
To remind, 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.
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 chemoradiation therapy and under regulatory review in the EU, Japan and other jurisdictions with expected decisions in the second half of 2018.