Durvalumab Plus Anlotinib Maintenance Improves PFS in Extensive-Stage Small Cell Lung Cancer

Clinical Summary:

• Design/Population: This phase 2 trial evaluated durvalumab plus anlotinib vs durvalumab alone as maintenance therapy after first-line durvalumab plus platinum-etoposide chemotherapy in patients with extensive-stage small cell lung cancer. 
• Key Outcomes: Maintenance therapy with durvalumab plus anlotinib significantly prolonged progression-free survival compared with durvalumab alone, with a manageable safety profile. 
• Clinical Relevance: These findings suggest that durvalumab plus anlotinib may represent a promising maintenance strategy following first-line chemoimmunotherapy in extensive-stage small cell lung cancer, supporting further evaluation in larger, confirmatory trials.

Maintenance therapy with durvalumab plus anlotinib improved progression-free survival (PFS) compared with durvalumab alone in patients with extensive-stage small cell lung cancer (ES-SCLC) following first-line chemoimmunotherapy, according to results from the phase 2 DURABLE trial.

“Although first-line immunotherapy plus chemotherapy has made substantial progress in ES-SCLC, the survival benefit remains limited.” stated Bo Zhang, MD, Shanghai Jiao Tong University School of Medicine, Shanghai, China, and coauthors. 

In this multicenter, open-label study, 66 patients were randomized to receive either durvalumab plus anlotinib (n = 34) or durvalumab alone (n = 32). The primary end point was PFS, assessed via blinded independent central review. A key secondary end point was safety. 

At analysis, median PFS was 5.4 months in the durvalumab plus anlotinib arm and 1.9 months in the durvalumab alone arm (hazard ratio [HR], 0.64; 80% confidence interval [CI], 0.44 to 0.94; P = .12). These results were confirmed by investigator-assessed median PFS (5.4 months vs 1.9 months; P = .13). 

Grade 3/4 treatment-related adverse events were reported in 24.2% of patients in the durvalumab plus anlotinib arm and 12.5% of patients in the durvalumab alone arm. 

Exploratory biomarker analyses suggested that patients with impaired antigen-presenting capacity or low blood tumor mutational burden (bTMB) tended to derive greater benefit from the combination maintenance strategy. In contrast, similar efficacy was observed between treatment groups among patients with high antigen-presenting capacity or high bTMB.

“These findings suggest that durvalumab plus anlotinib might be an effective and well-tolerated maintenance treatment option in ES-SCLC,” concluded Dr Zhang et al. 

Source:

Zhang B, Zhong R, Shi C, et al. Durvalumab plus anlotinib versus durvalumab alone as maintenance treatment in extensive-stage small-cell lung cancer (DURABLE): A multicenter, randomized, phase II trial and biomarker analysis. Nat Commun. Published online: May 25, 2026. doi: 10.1038/s41467-026-73562-7