Randomized phase 2 trial of addition of anlotinib to durvalumab maintenance in extensive-stage small cell lung cancer

The survival benefit with first-line immunotherapy plus chemotherapy in extensive-stage small cell lung cancer (ES-SCLC) remains limited. The multicenter, randomized phase 2 DURABLE trial evaluated efficacy and safety of durvalumab plus anlotinib (n=34) versus durvalumab alone (n=32) as maintenance therapy following first-line durvalumab plus platinum-etoposide chemotherapy in ES-SCLC. The primary endpoint was blinded independent central review-assessed progression-free survival (PFS). Durvalumab plus anlotinib significantly improved PFS compared with durvalumab alone, with median PFS from randomization 5.4 months versus 1.9 months (HR 0.64; 80% CI 0.44-0.94; p=0.12). The incidence of grade 3-4 treatment-related adverse events was 24.2% in the combination maintenance therapy group and 12.5% in the monotherapy group. Patients with impaired antigen presenting capacity or low bTMB tended to show improved outcomes with combination maintenance therapy, whereas similar efficacy between the two groups was observed in patients with high antigen presenting capacity or high bTMB. The authors conclude that durvalumab plus anlotinib might be an effective and well-tolerated maintenance treatment option in ES-SCLC.