Exploratory results from the global, phase 3 AEGAN study demonstrated that the addition of perioperative durvalumab to neoadjuvant chemotherapy improved efficacy with manageable safety among treatment-naive patients with resectable non-small cell lung cancer who had baseline N2 nodal status (N2 R-NSCLC). 

These data were presented by John Heymach, MD, PhD, University of Texas MD Anderson Cancer Center, Houston, Texas, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois.

As demonstrated in the overall intention-to-treat population, perioperative durvalumab plus neoadjuvant chemotherapy “was shown to significantly improve the primary end points of both event-free survival and pathologic complete response versus neoadjuvant chemotherapy alone,” stated Dr Heymach. 

In this trial, 740 patients with baseline N2 R-NSCLC, and this subgroup analysis included 366 patients with a baseline N2 nodal status, as determined by investigator. Patients were randomized on a 1-to-1 basis to receive 4 cycles of platinum-based chemotherapy plus either 1500 mg of durvalumab (N2 subgroup n = 181) or placebo (N2 subgroup n = 185) once every 3 weeks, followed by surgical resection and durvalumab or placebo once every 4 weeks for 12 cycles. Primary end points included event-free survival (EFS), pathologic complete response (pCR), and major pathological response. A key secondary end point was safety among patients who received ≥1 treatment dose (n = 394). 

At a median follow-up of 11.8 months, 83.4% of patients in the durvalumab arm completed 4 cycles of platinum-based chemotherapy compared to 84.9% of patients in the placebo arm. Surgical resection was completed by 73.5% of patients in the durvalumab arm and 71.9% of patients in the placebo arm. EFS rate was 26.5% in the durvalumab arm and 40.5% in the placebo arm. The pCR rate was 16.6% in the durvalumab arm and 4.9% in the placebo arm. Major pathological response was 32.6% and 15.1%, respectively. Max grade 3/4 any-cause adverse events occurred in 38.5% of patients in the durvalumab arm and 41.8% of patients in the placebo arm. 

“With clinically meaningful improvements in efficacy, no adverse impact on surgical outcomes, and a manageable safety profile, the addition of perioperative durvalumab to neoadjuvant chemotherapy remains a potential new treatment option for patients with N2 resectable non-small cell lung cancer,” concluded Dr Heymach. 

Source:

Heymach J, Reck M, Mitsudomi T, et al. Outcomes with perioperative durvalumab (D) in pts with resectable NSCLC and baseline N2 lymph node involvement (N2 R-NSCLC): An exploratory subgroup analysis of AEGEAN. Presented at the ASCO Annual Meeting. May 31-June 4, 2024; Chicago, IL. Abstract #8011