Multinational phase 3 trial of durvalumab versus placebo after chemoradiotherapy for limited-stage small cell lung cancer

The multinational phase 3 ADRIATIC trial randomized patients with limited-stage small cell lung cancer without disease progression after chemoradiotherapy to durvalumab, durvalumab plus tremelimumab, or placebo every four weeks for up to 24 months. First interim analysis of the durvalumab monotherapy and placebo groups has now been published. Median overall survival was 55.9 months with durvalumab versus 33.4 months with placebo (HR 0.73; p=0.01) whereas median progression-free survival was 16.6 months with durvalumab versus 9.2 months with placebo (HR 0.76; p=0.02). The incidence of grade 3 or 4 adverse events was 24.4% with durvalumab and 24.2% with placebo, the incidence of AEs resulting in discontinuation was 16.4% versus 10.6%, and the incidence of AEs resulting in death was 2.7% and 1.9%. The authors conclude that adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage small cell lung cancer.