AstraZeneca, along with its global biologics research and development arm MedImmune, has reported positive results from the PACIFIC trial, a Phase III study of Imfinzi (durvalumab) to treat patients with unresectable Stage III non-small cell lung cancer (NSCLC).
The results are based on a planned interim analysis carried out by an Independent Data Monitoring Committee.
The analysis has found that the randomised, double-blinded, placebo-controlled, multi-centre PACIFIC trial met its second primary endpoint of overall survival (OS) by showing clinically meaningful improvement in patients receiving Imfinzi compared to placebo.
The trial’s first primary endpoint includes progression-free survival (PFS), which was achieved in May last year.
It also features the overall response rate and duration of response as additional primary endpoints.
A total of 713 NSCLC patients whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT) have been enrolled in the trial.
The trial is currently being conducted in 235 centres across 26 countries worldwide.
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 binds to PD-L1 and thwarts the interaction of PD-L1 with PD-1 and CD80 to check the tumour's immune-evading tactics and release the inhibition of immune responses.
Earlier this month, the solution secured approval in Canada for the treatment of patients with unresectable Stage III NSCLC following CRT.
In February this year, the US Food and Drug Administration (FDA) approved Imfinzi for the treatment of unresectable Stage III NSCLC patients who had not progressed following concurrent platinum-based CRT.