AZ reports detailed stage III NSCLC data from Phase III PACIFIC trial of Imfinzi

AstraZeneca plc (LSE:AZN; NYSE:AZN) reported additional data from a planned interim analysis of the Phase III PACIFIC trial to treat stage III unresectable non-small cell lung cancer (NSCLC) in “all-comer" patients showing that IV Imfinzi durvalumab led to a median progression-free survival (PFS), a co-primary endpoint, of 16.8 months, vs. 5.6 months for placebo (HR=0.52, 95% CI: 0.42, 0.65, p<0.001). Imfinzi led to 12- and 18-month PFS rates of 55.9% and 44.2%, respectively, vs. 35.3% and 27% for placebo. Median duration of response has not yet been reached for Imfinzi vs. 13.8 months for placebo. Additionally, Imfinzi led to an overall response rate (ORR) of 28.4% vs. 16% for placebo (p<0.001). Median time to to death or distant metastases was 23.2 months for Imfinzi vs. 14.6 months for placebo (p<0.001). AZ said the trial continues to evaluate the co-primary endpoint of overall survival (OS).

The double-blind, international trial enrolled 713 patients with locally advanced, unresectable NSCLC who have not progressed following platinum-based chemotherapy concurrent with radiation to receive placebo or Imfinzi for up to 12 months. Data were presented at the European Society for Medical Oncology meeting in Madrid and published in the New England Journal of Medicine...