Sintilimab Plus Anlotinib Demonstrates Promise in Relapsed/Refractory Small Cell Lung Cancer
Results from a phase 2 trial suggest that sintilimab plus anlotinib demonstrates encouraging efficacy with manageable safety among patients with relapsed/refractory small cell lung cancer (SCLC) who have a short chemotherapy-free interval.
These results were presented at the 2026 European Lung Cancer Congress in Copenhagen, Denmark, by Lan Shao, MD, Zhejiang Cancer Hospital, Hangzhou, China.
In this prospective study, 18 patients with a chemotherapy free interval of ≤6 months, including those initially diagnosed with either limited- (n = 9) or extensive-stage disease (n = 9), received 200 mg of sintilimab every 3 weeks plus 12 mg of anlotinib on days 1 to 14 of each 3-week cycle. The primary end point was objective response rate (ORR). Secondary endpoints including disease control rate, progression-free survival (PFS), overall survival (OS), and safety.
At analysis, the ORR was 38.9%. In patients initially diagnosed with limited-stage disease ORR was 44.4% and in patients initially diagnosed with extensive-stage disease ORR was 33.3%. The disease control rate was 61.1%. Median PFS was 4.6 months, and median OS was 11.5 months. Grade ≥3 treatment-related adverse events were reported in 22.2% of patients. No unexpected immune-related adverse events were reported.
“The combination of sintilimab with anlotinib showed encouraging efficacy and manageable toxicity in relapsed and refractory SCLC patients with ≤6-month [chemotherapy-free interval],” concluded Dr Shao et al. “Further evaluation is ongoing.”
Source:
Shao L, Wang W, Wang Y, et al. Efficacy and safety of sintilimab combined with anlotinib in relapsed and refractory small cell lung cancer: A phase 2 clinical trial. Presented at European Lung Cancer Congress. March 25 - 28, 2026. Copenhagen, Denmark. 428P.
