Multinational phase 3 trial of perioperative durvalumab for resectable non-small cell lung cancer

The multinational phase 3 AEGEAN trial randomized patients with resectable non-small cell lung cancer (NSCLC, stage II to IIIB) to receive platinum-based chemotherapy plus durvalumab or platinum-based chemotherapy plus placebo for 4 cycles before surgery, followed by adjuvant durvalumab or placebo every 4 weeks for 12 cycles. Primary end points were event-free survival (defined as time to earliest occurrence of progressive disease that precluded surgery or prevented completion of surgery, disease recurrence, or death from any cause) and pathological complete response. At the first interim analysis, the duration of event-free survival was significantly longer with durvalumab than with placebo (HR 0.68; p=0.004). At 12 monts, event-free survival was observed in 73.4% of patients receiving durvalumab, as compared with 64.5% of patients receiving placebo. The incidence of pathologic complete response was 17.2% in the durvalumab group as compared with 4.3% of the placebo group (p<0.001). Adverse events of grade 3 or 4 occurred in 42.4% of patients receiving durvalumab and in 43.2% of patients receiving placebo. The authors conclude that in patients with resectable NSCLC, perioperative durvalumab plus neoadjuvant chemotherapy was associated with significantly greater event-free survival and pathological complete response than neoadjuvant chemotherapy alone.