The trial had met its second of two primary endpoints by demonstrating statistically significant OS benefit with clinically meaningful improvement in patients, subjected to Imfinzi, in comparison to placebo.
AstraZeneca’s late-stage trial for Imfinzi is being conducted across 26 countries having enrolled 713 patients. The primary endpoints of the trial are progression-free survival (PFS) and OS while secondary endpoints include PFS and OS, overall response rate and duration of response.
In last May, the PACIFIC trial met its first primary endpoint of PFS by showing a median improvement of 11.2 months compared placebo, as evaluated by blinded independent central review.
Imfinzi has approvals in the US and Canada for treating unresectable Stage III NSCLC in patients whose condition has not progressed after platinum-based chemoradiation therapy. It is being assessed by regulators in the European Union, Japan and other regions with regulatory decisions expected to come in the second half of the year.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “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.”
Imfinzi is a human monoclonal antibody that targets the PD-1/PD-L1 pathway. It has been designed to prevent the interaction of PD-L1 with PD-1 and CD80 proteins to work against the immune-evading tactics of the tumor and releasing the inhibition of immune responses.
Image: AstraZeneca’s Imfinzi succeeds in phase 3 PACIFIC trial. Photo: courtesy of AstraZeneca.