AstraZeneca reports on FDA ODAC review of Imfinzi in NSCLC

AstraZeneca stated: “The Food and Drug Administration’s Oncologic Drugs Advisory Committee – ODAC – acknowledged that AstraZeneca’s Imfinzi met the primary endpoint of event-free survival – EFS – in the treatment of resectable non-small cell lung cancer – NSCLC – based on the AEGEAN Phase III trial results with an overall tolerable safety profile. In the trial, adult patients with resectable early-stage NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements were treated with Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery. The discussion noted that while the contribution by phase of neoadjuvant and adjuvant components of the perioperative regimen could not be clearly assigned based on the trial design, this is an important potential regimen for patients.” Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “The Committee’s discussion of the AEGEAN data highlighted the significant benefit delivered by this Imfinzi-based regimen for patients with resectable lung cancer. We are committed to working closely with the FDA to bring this novel immunotherapy option to patients that offers a flexible chemotherapy backbone.” The company added: “The ODAC provides the FDA with independent, expert advice and recommendations on marketed and investigational medicines for use in the treatment of cancer. The FDA will consider the feedback as it reviews the submission and is not bound by the Committee’s recommendation. Imfinzi is approved in Switzerland and the UK for the treatment of adults with resectable NSCLC in Stage II and III without known EGFR mutations or ALK rearrangements, based on the AEGEAN results. Regulatory applications for Imfinzi in this setting are also currently under review in the EU, China and several other countries. Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy based on the PACIFIC Phase III trial.”