Interim analysis shows clinical benefit of Imfinzi for unresectable non-small cell lung cancer

AstraZeneca and its global biologics research and development arm, MedImmune, have announced positive overall survival (OS) results of the Phase III PACIFIC trial evaluating Imfinzi (durvalumab) for the treatment of unresectable stage III non-small cell lung cancer (NSCL).

“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,” said Sean Bohen, executive vice president, Global Medicines Development and chief medical officer at AstraZeneca. “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.”

In May last year (2017), AstraZeneca had announced that the primary endpoint of the PACIFIC trial had been met as a median improvement of progression-free survival (PFS) of 11.2 months versus that of placebo was found.

This latest announcement comes after a planned interim analysis, conducted by an Independent Data Monitoring Committee, demonstrated that the trial has now met its second of two primary endpoints — showing statistically significant OS benefit with clinically meaningful improvement in patients receiving Imfinzi compared with placebo. The safety and tolerability profile for Imfinzi was consistent with that reported at the time of the PFS analysis.

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.