FDA Approves Use of Durvalumab With Chemotherapy Before and After Surgery in NSCLC

By: JNCCN 360 Staff
Posted: Friday, August 16, 2024

The U.S. Food and Drug Administration (FDA) recently approved the use of the monoclonal antibody durvalumab (Imfinzi) in combination with chemotherapy for treatment of adults with resectable, early-stage (IIA–IIIB) non–small cell lung cancer (NSCLC) and no known EGFR mutations or ALK rearrangements. With this regimen, patients are treated with the neoadjuvant combination neoadjuvant therapy before surgery and as adjuvant monotherapy after surgery. Durvalumab is the only approved immunotherapy 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.

This recent approval was based on the results of the AEGEAN trial. The findings from a planned interim analysis of event-free survival showed a statistically significant and clinically meaningful 32% reduction in the risk of cancer recurrence, disease progression events, or death vs chemotherapy alone in patients treated with the durvalumab-based regimen before and after surgery (32% data maturity; event-free survival hazard ratio = 0.68; 95% confidence interval [CI] = 0.53–0.88; P = .003902). In a final analysis of pathologic complete response, treatment with durvalumab plus neoadjuvant chemotherapy before surgery resulted in a pathologic complete response rate of 17.2% vs 4.3% with neoadjuvant chemotherapy alone.

No new safety signals were observed in the neoadjuvant and adjuvant settings. Furthermore, adding durvalumab to neoadjuvant chemotherapy appeared to be consistent with the known profile for this combination and did not seem to compromise patients’ ability to complete surgery vs chemotherapy alone.

U.S. Food and Drug Administration

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