AstraZeneca announced Friday results from a Phase III trial showing that Imfinzi (durvalumab) significantly improved overall survival (OS) compared to placebo in patients with unresectable Stage III non-small-cell lung cancer (NSCLC) whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy.
Last year, the company reported that the PACIFIC trial met its first primary endpoint of progression-free survival (PFS) by demonstrating a median improvement of 11.2 months versus placebo, as assessed by blinded independent central review. AstraZeneca said Friday that following a planned interim analysis conducted by an Independent Data Monitoring Committee, the study also met the second main goal of OS.
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." The company noted that Imfinzi's safety and tolerability profile was consistent with that reported at the time of the PFS analysis.
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The trial randomised 713 patients with Stage III unresectable NSCLC whose disease has not progressed following platinum-based chemoradiation therapy to receive Imfinzi or placebo. Along with the primary endpoints of PFS and OS, secondary goals include overall response rate and duration of response. AstraZeneca indicated that it plans to present results from the study at an upcoming medical meeting.
"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," remarked Bohen. The PD-L1 inhibitor 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. Imfinzi is also under review in the EU and Japan in this indication, with decisions expected in the second half.
Commenting on the news, Berenberg analysts said "consensus has peak Imfinzi sales at $2.8 billion by 2023 and the achievement of an OS benefit may not result in much of a change in sales expectations." However, the analysts noted that "the OS data will help Astra in its physician education and ensure the peak sales can be achieved."
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