FDA Approves Durvalumab with Chemotherapy for Perioperative Treatment of Resectable NSCLC
AstraZeneca
Biopharmaceutical Manufacturer
Preface
On August 15 local time, the U.S. Food and Drug Administration (FDA) approved durvalumab in combination with platinum-based chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery, for adult patients with resectable (tumor ≥4 cm and/or lymph node-positive) non-small cell lung cancer (NSCLC) who have no known epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) rearrangement.
This approval is based on data from the Phase III AEGEAN trial (NCT03800134). The AEGEAN study is a randomized, controlled, double-blind, international multicenter Phase III clinical trial designed to evaluate the efficacy and safety of the "neoadjuvant immunotherapy + surgical resection + postoperative adjuvant immunotherapy" regimen using durvalumab in patients with resectable EGFR- and ALK-negative Stage IIA-IIIB (N2) NSCLC.
The study enrolled a total of 802 patients, who were randomly assigned in a 1:1 ratio to the experimental group (Group D: neoadjuvant therapy with durvalumab 1500mg + platinum-based doublet chemotherapy Q3W for 4 cycles, adjuvant therapy with durvalumab 1500mg Q4W for 12 cycles) and the control group (PBO group: neoadjuvant therapy with placebo + chemotherapy, adjuvant therapy with placebo). The primary endpoints of the study were pathological complete response (pCR) and event-free survival (EFS), with key secondary endpoints including major pathological response (MPR), overall survival (OS), disease-free survival (DFS), safety, and quality of life.
At the 2023 American Association for Cancer Research (AACR) Annual Meeting, the AEGEAN study announced for the first time that it had achieved positive results for both primary endpoints. The median follow-up time was 11.7 months. The median EFS for the D group and the PBO group were not reached (NR) and 25.9 months, respectively (HR=0.68; 95% CI: 0.53-0.88; P=0.0039); the pCR rate in the D group increased by 13% compared to the PBO group (17.2% vs 4.3%), and the MPR rate increased by 21% (33.3% vs 12.3%). In terms of safety, the incidence of all adverse events (AE) in the two groups (96.5% vs 94.7%) and the incidence of grade 3/4 AEs were similar (42.3% vs 43.4%), consistent with the known AE profiles of chemotherapy and immunotherapy.
For patients weighing ≥30kg, the recommended dose of durvalumab is 1500mg every 3 weeks (neoadjuvant therapy) and 1500mg every 4 weeks (adjuvant therapy). For patients weighing <30kg, the recommended dose of durvalumab is 20mg/kg. If durvalumab is administered on the same day, it should be given before chemotherapy.
References:
FDA approves neoadjuvant/adjuvant durvalumab for resectable non-small cell lung cancer. FDA. August 15, 2024. Accessed August 15, 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-neoadjuvantadjuvant-durvalumab-resectable-non-small-cell-lung-cancer
Editor: Faline
Reviewed by: Faline
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