Henlius Serplulimab First to Show Positive Post-Surgery Chemo-Free Result in Gastric Cancer at ASCO
At the 2026 ASCO annual meeting, Peking University Cancer Hospital's Professor Shen Lin presented the ASTRUM-006 phase III study, showing that Henlius' serplulimab achieved the first global positive result for a post-surgery chemotherapy-free regimen in perioperative gastric cancer. The trial involved 57 centers and 588 patients, with a design of three cycles of preoperative chemo-immunotherapy followed by up to 17 cycles of immunotherapy alone. The study met its primary endpoint of event-free survival at the interim analysis in October 2025. Nearly half of gastric cancer patients worldwide are in China, and the Western triple chemotherapy regimen is applicable to less than 10% of East Asian populations. Over the past 30 years, the five-year survival rate for gastric cancer has improved from about 20% to 40-50%.
On June 1, 2026, at the American Society of Clinical Oncology (ASCO) annual meeting, Professor Shen Lin 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 first drug globally to achieve a positive result in the perioperative treatment of gastric cancer with a "post-surgery chemotherapy-free" regimen.
The study was initiated at the end of 2018 and was designed to administer three cycles of chemotherapy combined with immunotherapy before surgery, followed by up to 17 cycles of immunotherapy alone as adjuvant therapy after surgery, with no further chemotherapy. Initially, patient recruitment was difficult, with only 16 patients enrolled. Through communication and case demonstrations, enrollment gradually improved, and all 588 patients were enrolled by 2024. In October 2025, the interim analysis met the primary endpoint of event-free survival (EFS).
Nearly half of the world's gastric cancer patients are in China. There are biological differences in treatment tolerance between Eastern and Western gastric cancer patients. The three-drug combination chemotherapy regimen commonly used in the United States and Europe is applicable to less than 10% of the East Asian population. From 2012 to 2022, China published 579 papers on gastric cancer immunotherapy, compared to 205 in the United States. Over the past 30 years, the five-year survival rate for gastric cancer has improved from approximately 20% to between 40% and 50%.
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