Perioperative Durvalumab Shows Promise for Resectable NSCLC

Adjuvant therapy with the PD-L1 inhibitor durvalumab has dramatically improved outcomes for patients with locally advanced unresectable non–small-cell lung cancer (NSCLC) receiving chemoradiation (NEJM JW Onc Hem Oct 10 2018 and N Engl J Med 2018; 379:2342). The phase 3 AEGEAN trial evaluated durvalumab in patients with newly diagnosed stage II to IIIB resectable NSCLC receiving chemotherapy and surgery. In the multinational, industry-funded trial, 802 patients were randomized to platinum-based chemotherapy plus either durvalumab or placebo every 3 weeks for 4 cycles before surgery, followed by adjuvant durvalumab or placebo every 4 weeks for 12 cycles. The primary endpoints were event-free survival and pathological complete response (pCR) in the modified intention-to-treat population of 740 patients without EGFR or ALK alterations.

At 12 months, 17.2% of patients in the durvalumab group achieved pCR, compared to 4.3% of those in the control group. Event-free survival strongly favored durvalumab, with a hazard ratio for progression, recurrence, or death of 0.68 (95% CI, 0.53–0.88; P=0.004). Improvement in event-free survival was observed regardless of PD-L1 expression or disease stage. Adverse events led to discontinuation of durvalumab in 12% of patients and placebo in 6%. No new safety signals were seen.