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AACR 2023: Phase III AEGEAN Trial of Durvalumab-Based Therapy Meets Primary Endpoints in Resectable NSCLC

By: Amy MacDonald, MS
Posted: Monday, May 1, 2023

The randomized, double-blind, placebo-controlled, international AEGEAN trial assessed the activity of neoadjuvant durvalumab (anti–PD-L1 monoclonal antibody) plus chemotherapy compared with neoadjuvant placebo plus chemotherapy (in combination with postsurgical durvalumab or placebo) in patients with resectable non–small cell lung cancer (NSCLC). At the American Association for Cancer Research (AACR) Annual Meeting 2023 (Abstract CT005), John V. Heymach, MD, PhD, of The University of Texas MD Anderson Cancer Center, Houston, and colleagues reported that this phase III trial met both of its primary endpoints—improved pathologic complete response and event-free survival—in treatment-naive patients who received neoadjuvant durvalumab plus chemotherapy followed by durvalumab in the postsurgical setting. Although previous NSCLC trials have demonstrated the clinical benefit of either neoadjuvant or adjuvant immunotherapy, AEGEAN is the first to assess the use of durvalumab both before and after surgery.

“This study shows that a combination of neoadjuvant and adjuvant durvalumab offers benefit for patients and may have the potential to change [the] standard of care for patients with resectable [NSCLC] ,” stated Dr. Heymach in an MD Anderson press release.

The AEGEAN trial enrolled 799 patients (durvalumab arm, n = 400; placebo arm, n = 399) with stage II to IIIB resectable NSCLC. Overall, 84.7% of the durvalumab arm and 87.2% of the placebo arm completed four cycles of platinum-doublet chemotherapy, and 77.6% and 76.7%, respectively, completed surgery. Pathologic complete response rates were significantly higher in the arm receiving durvalumab (17.2%) compared with placebo (4.3%; P = .000036), as was event-free survival. As for the safety profile, grade 3 or 4 adverse events occurred in 42.3% and 43.4% of patients in the durvalumab and placebo arms, respectively.

Disclosure: Disclosures for the study authors can be found at

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