Results presented at ESMO
Shanghai Henlius Biotech announced on October 26, 2026, at the European Society for Medical Oncology Congress 2026, positive results from ASTRIDE, a randomized, descriptive, open-label study conducted in the United States. The trial compared serplulimab plus carboplatin and etoposide with atezolizumab plus chemotherapy in patients receiving first-line treatment for extensive-stage small cell lung cancer. The study was led by David R. Gandara, professor emeritus at the University of California Davis Comprehensive Cancer Center in Sacramento, the company said. Henlius is based in Shanghai.
Overall survival of 12.4 versus 10.2 months
At a data cutoff of February 18, 2026, median follow-up was 14.1 months. Median overall survival was 12.4 months with serplulimab and 10.2 months with atezolizumab, a hazard ratio of 0.82 with a 95% confidence interval of 0.56 to 1.20. One-year survival rates were 52.4% and 41.4%, and two-year rates were 32.2% and 17.6%. The serplulimab group had a higher share of patients with liver metastasis, at 49.5% against 40.0%. The trial randomized 201 patients at 63 sites between 2022 and 2025 in a 1:1 ratio. Analyses were descriptive and no formal testing for superiority or noninferiority was planned, the company said.
Secondary endpoints and safety
Median progression-free survival assessed by blinded independent central review was 5.4 months with serplulimab and 4.9 months with atezolizumab. Objective response rates were 65.7% and 67.0%, and median duration of response was 4.2 and 4.0 months. Among the 158 patients with no prior chemotherapy for newly diagnosed disease, median overall survival was 13.4 and 10.8 months, with a hazard ratio of 0.77. Grade 3 or higher treatment-emergent adverse events occurred in 73.7% of serplulimab patients and 73.0% of atezolizumab patients. The release said 5% of participants were Black or African American and 4.5% were Hispanic or Latino.
What the company says the data support
Gandara said the results were consistent with ASTRUM-005, a global, randomized, double-blind Phase 3 trial, and that the two-year survival rate of 32% was identical in both studies. Henlius chief executive Jason Zhu said serplulimab is a current treatment option in Europe and other markets and that the two studies reflect potential benefit for U.S. patients. Serplulimab has been approved in more than 50 countries and regions for several indications, and the U.S. Food and Drug Administration granted it orphan-drug designation for small cell lung cancer in March 2022.