Henlius Serplulimab Achieves Global First Positive Result in Perioperative Gastric Cancer 'Post-Surgery
At the 2026 ASCO annual meeting, Professor Lin Shen from Peking University Cancer Hospital presented the ASTRUM-006 study, a seven-year phase III trial across 57 centers and 588 patients. The results show Henlius' serplulimab is the world's first drug to achieve a positive 'post-surgery chemo-free' endpoint in perioperative gastric cancer. The study, launched in late 2018, initially struggled with recruitment but completed all 588 patients by 2024, with an interim analysis in October 2025 meeting the primary endpoint of event-free survival. Nearly half of global gastric cancer patients are in China, where tolerance to standard triplet chemotherapy is limited to less than 10% of the East Asian population, compared with a rise in five-year survival from about 20% to 40%-50% over the past three decades.
On June 1, 2026, at the American Society of Clinical Oncology (ASCO) annual meeting, Professor Lin Shen from Peking University Cancer Hospital presented data from the ASTRUM-006 study. This seven-year phase III clinical trial involved 57 centers and 588 patients. The results showed that Henlius' serplulimab became the world's first drug to achieve a positive 'post-surgery chemo-free' endpoint in the perioperative treatment of gastric cancer.
The study, initiated in late 2018, was designed to give three cycles of chemotherapy combined with immunotherapy before surgery, followed by up to 17 cycles of single-agent immunotherapy after surgery, with no further chemotherapy. Initial patient recruitment was challenging, with only 16 participants enrolled. Through communication and case presentations, enrollment gradually improved, and all 588 patients were recruited by 2024. An interim analysis in October 2025 met the primary endpoint of event-free survival (EFS).
Nearly half of the world's gastric cancer patients are in China. Biological differences in treatment tolerance exist between Eastern and Western patients, and the standard triplet chemotherapy regimen used in Europe and the United States is applicable to less than 10% of the East Asian population. From 2012 to 2022, China and the United States published 579 and 205 papers, respectively, on gastric cancer immunotherapy. Over the past 30 years, the five-year survival rate for gastric cancer has improved from about 20% to 40%-50%.
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