AstraZeneca releases new data on Imfinzi for the treatment of resectable non-small cell lung cancer based on AEGEAN Phase III trial results

The FDAs Oncologic Drugs Advisory Committee has acknowledged that AstraZeneca’s Imfinzi has met the primary endpoint of event-free survival in the treatment of resectable non-small cell lung cancer 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.

John V. Heymach, MD, PhD, Professor and Chair Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center in Houston, Texas, said: “The majority of patients with resectable lung cancer face recurrence of their disease even after surgery and neoadjuvant chemotherapy. The Committee acknowledged the potential to address this urgent unmet need with durvalumab both before and after surgery, which can significantly increase the time patients live without progression and recurrence events in this curative-intent setting.”

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.”

Results from their planned interim analysis of EFS from the AEGEAN trial showed a statistically significant and clinically meaningful 32% reduction in the risk of recurrence, progression events or death versus chemotherapy alone in patients treated with the Imfinzi-based regimen before and after surgery. In a final analysis of pathologic complete response, treatment with Imfinzi plus neoadjuvant chemotherapy before surgery resulted in a pCR rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone.

Imfinzi is now approved in Switzerland and the UK for treatment of adults with resectable NSCLC in Stages II and III without known EGFR mutations or ALK rearrangements, based on the AEGEAN results. Regulatory applications for Imfinzi in this setting are also under review in the EU, China and several other countries.

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Related Topics and Keywords

AEGEAN Phase III trial, FDA, non-small cell lung cancer, resectable non-small cell lung cancer