Shanghai Henlius Biotech, Inc has announced positive results from ASTRIDE, a randomised, descriptive, open-label, US study of serplulimab (in Europe, Hetronifly), an anti-PD-1 monoclonal antibody (mAb), in combination with carboplatin and etoposide (chemotherapy) compared to atezolizumab plus chemotherapy for first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
The announcement was made at the European Society for Medical Oncology (ESMO) Congress 2026.
The study is led by David R. Gandara, professor emeritus at the University of California Davis Comprehensive Cancer Center in Sacramento, California.
As of data cutoff on February 18, 2026, the median follow-up duration was 14.1 months. Despite a higher proportion of patients with liver metastasis in the serplulimab group than in the atezolizumab group (49.5% vs 40.0%), median OS was numerically longer with serplulimab than with atezolizumab (12.4 vs 10.2 months; hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.56-1.20). One-year OS rates were 52.4% and 41.4%, and two-year OS rates were 32.2% and 17.6%, respectively.
Gandara said, “ES-SCLC is a rapidly progressive and life-threatening disease. Overall survival is the primary endpoint. The results are remarkably consistent with those of ASTRUM-005. In particular, the two-year survival rate of 32% is identical in both studies, ASTRIDE and the previous ASTRUM-005 phase 3 trial. These results provide an important clinical assessment of serplulimab in the US patient population and strongly support the benefit of serplulimab and applicability of the ASTRUM-005 findings to the US patients with ES-SCLC in the first-line setting.” Jason Zhu, executive director and CEO of Henlius, said: “Serplulimab is a current treatment option for patients in Europe and other global markets, and the results from our ASTRIDE study, combined with our ASTRUM-005 Phase 3 trial, reflect the potential benefit for US patients with ES-SCLC, a rare and aggressive disease. These encouraging results further validate our strategy and commitment to finding better treatment options for patients worldwide.”