The second planned interim analysis of the global phase III AEGEAN trial—reported by John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues at the International Association for the Study of Lung Cancer (IASLC) 2024 World Conference on Lung Cancer (WCLC)—confirmed the safety and efficacy of perioperative use of the monoclonal antibody durvalumab plus neoadjuvant chemotherapy in patients with resectable non–small cell lung cancer (NSCLC; Abstract OA13.03).
Study Details
A total of 802 treatment-naive patients with stage II to IIIB resectable NSCLC were randomly assigned 1:1 to receive neoadjuvant platinum-based chemotherapy plus either intravenous durvalumab or a placebo every 3 weeks for four cycles. Following surgery, they continued the same treatment every 4 weeks for 12 cycles.
Of the randomly assigned population, 799 were treated (durvalumab: n = 400; placebo: n = 399). Follow-up data were provided for a median of 25.9 months.
Updated Results
Consistent with previous findings, median event-free survival was found to favor durvalumab vs the placebo in the EGFR/ALK wild-type modified intention-to-treat population (not reached [NR] vs 30.0 months; hazard ratio [HR] = 0.69), including within the subgroups treated with cisplatin-based chemotherapy (NR vs 45.0 months; HR = 0.58) and carboplatin-based chemotherapy (NR vs 26.2 months; HR = 0.75). The investigators reported a clinically meaningful disease-free survival benefit (in modified resected subpopulation: NR vs NR; HR = 0.66) and a trend toward improved overall survival (in modified intention-to-treat population: NR vs 53.2 months; HR = 0.89) with durvalumab.
KEY POINTS
- In patients with resectable NSCLC undergoing neoadjuvant chemotherapy, the updated data continued to show an event-free survival benefit with the addition of perioperative durvalumab.
- The investigators reported a clinically meaningful disease-free survival benefit and a trend toward improved overall survival with durvalumab.
- The regimen was found to be associated with a manageable adverse event profile, with no new safety signals emerging.
The event-free survival benefit with durvalumab was more pronounced in patients who did vs did not undergo adjuvant therapy (HR = 0.62 vs 0.83) and was observed regardless of pathologic complete response status (with: HR = 0.73; without: HR = 0.81), based on exploratory analyses. Furthermore, an improvement in lung cancer–specific survival was documented (NR vs NR; HR = 0.70).
The maximum rates of grade 3 and 4 adverse events were not found to differ between the durvalumab (43.6%) and placebo (43.2%) arms during the overall period. During the adjuvant period, the rates were 15.4% and 10.6%, respectively.
Dr. Heymach concluded: “We previously reported a significant improvement in event-free survival and pathologic complete response [with neoadjuvant chemotherapy plus perioperative durvalumab], with a safety profile consistent with the individual agents. The updated data further support the recently U.S. Food and Drug Administration (FDA)-approved perioperative durvalumab regimen as a new treatment option.”
DISCLOSURE: For full disclosures of the study authors, visit https://wclc2024.iaslc.org/cme-information.
