Dr Patel on the FDA Approval of Durvalumab Plus Chemotherapy for NSCLC

Sandip P. Patel, MD, professor, medicine, Department of Medicine, medical oncologist, Precision Immunotherapy Clinic, Moores Cancer Center, University of San Diego (UCSD), UCSD Health, discusses the significance of the FDA approval of perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy for patients with non–small cell lung cancer (NSCLC).

In August 2024, durvalumab in combination with platinum-containing chemotherapy in the neoadjuvant settingfollowed by single-agent durvalumab in the adjuvant setting was approved by the FDA for the treatment of adult patients with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or ALKrearrangements.

This approval is significant because it introduces immune checkpoint blockade into earlier stages of NSCLC, Patel begins. This earlier use of immunotherapy could enhance its efficacy and potentially increase the number of patients cured of NSCLC, he explains.

This regulatory decision was based on data from the phase 3 AEGEAN trial (NCT03800134), which investigated the use of perioperative durvalumab plus neoadjuvant chemotherapy in patients with resectable NSCLC. The study included patients with localized, resectable NSCLC ranging from stage II to stage IIIB at diagnosis in whom surgery was feasible, Patel continues. The primary end point of the trial was pathologic complete response, defined as the number of patients who had complete tumor eradication in pathology reports at the time of surgery. Another key focus of the trial was survival, which remains the gold standard for assessing treatment efficacy, especially in the context of immunotherapy, where the goal is to increase the number of cured patients, he emphasizes.

A critical insight gained from AEGEAN, as with similar trials, was the need to test for EGFR and ALK mutations, Patel expands. Patients with these mutations do not benefit significantly from immunotherapy, including treatments like durvalumab, and respond better to chemotherapy or targeted therapies, he adds. Therefore, performing appropriate molecular testing is essential, according to Patel. Notably, patients in AEGEAN benefited from the durvalumab plus chemotherapy regimen regardless of their PD-L1 status, Patel concludes.