AZ’s Imfinzi hits second major milestone at Phase 3 in unresectable lung cancer
pharmafile | May 25, 2018 | News story | Medical Communications, Research and Development | AstraZeneca, Imfinzi, NSCLC, lung cancer, pharma
AstraZeneca and its global biologics R&D MedImmune have lifted the curtain on new Phase 3 data for their immunotherapy Imfinzi (durvalumab) in the treatment of unresectable Stage III non-small cell lung cancer (NSCLC) in patients whose disease had not progressed following platinum-based chemotherapy concurrent with radiation therapy (CRT).
The data, as confirmed by an Independent Data Monitoring Committee, showed that AZ’s drug met its second primary endpoint, generating statistically-significant improvements to overall survival (OS) compared to placebo.
This second major milestone for the drug follows the reveal in May last year that it had met its first primary endpoint of progression-free survival, with median improvements of 11.2 months compared to placebo.
Imfinzi’s safety profile was found to be consistent with previous studies, and AZ plans to unveil the details of the latest data at an upcoming medical meeting. The drug is currently approved in the US and Canada in unresectable Stage 3 NSCLC that has not progressed following platinum-based chemoradiation therapy, and is awaiting approval in the EU and Japan.
“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,” commented Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca. “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.”
Matt Fellows
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