Multinational phase 3 trial of perioperative durvalumab for resectable NSCLC: updated outcomes from AEGEAN

The first planned interim analysis (median follow-up 11.7 months) of the multinational phase 3 AEGEAN trial found that perioperative durvalumab plus neoadjuvant chemotherapy, compared with neoadjuvant chemotherapy alone, significantly improved event-free survival (EFS) and pathologic complete response (pCR) among patients with resectable non-small cell lung cancer (R-NSCLC), with a safety profile consistent with the known profiles of the individual agents. Results from the second interim analysis (median follow-up 25.9 months) have now been published. Patients with treatment-naïve R-NSCLC (stage II-IIIB) were randomized 1:1 to neoadjuvant platinum-based chemotherapy plus durvalumab (n=400) or placebo (n=402) once every 3 weeks for four cycles, followed by surgery and adjuvant durvalumab or placebo once every 4 weeks, 12 cycles). EFS benefit favoring the durvalumab arm remained consistent (HR 0.69; 95% CI 0.55-0.88). Numerical improvements in disease-free survival (HR 0.66; 95% CI 0.47-0.92) and overall survival (0.89; 0.70-1.14) favored the durvalumab arm. Maximum grade 3-4 adverse events occurred in 15.4% and 10.6% of the durvalumab and placebo arms, respectively, during adjuvant treatment. The authors conclude that these results further support perioperative durvalumab plus neoadjuvant chemotherapy as a treatment option for R-NSCLC.