AZ's Imfinzi meets PFS endpoint in Phase III NSCLC trial

AstraZeneca plc (LSE:AZN; NYSE:AZN) said IV Imfinzi durvalumab met the co-primary endpoint of improving progression-free survival (PFS) vs. placebo in an interim analysis of the Phase III PACIFIC trial to treat stage III unresectable non-small cell lung cancer (NSCLC) in “all-comer" patients. AZ said the co-primary endpoint of overall survival (OS) "will be assessed in due course." The pharma is discussing its submission plans with regulatory authorities.

The double-blind, international trial plans to enroll about 983 patients with locally advanced, unresectable NSCLC who have not progressed following standard platinum-based chemotherapy concurrent with radiation to receive placebo or Imfinzi for up to 12 months. Secondary endpoints include 24-month OS rate, duration of response, objective response rate (ORR), 12- and 18-month PFS rates and time to death or distant metastases...