Chinese Phase 3 Trial Shows Serplulimab-Based Regimen Reduces Gastric Cancer Recurrence Risk by 33% While Sparing Postoperative Chemotherapy
核心洞察
The Phase 3 ASTRUM-006 trial demonstrated that a serplulimab-based perioperative regimen reduced the risk of disease progression, recurrence, or death by 33% compared with conventional perioperative chemotherapy in resectable gastric cancer (搜索).
The regimen combines the anti-PD-1 (搜索) monoclonal antibody serplulimab with neoadjuvant chemotherapy, followed by postoperative serplulimab monotherapy, eliminating the need for postoperative chemotherapy in selected patients.
China's National Medical Products Administration approved the serplulimab-based regimen for perioperative treatment of gastric cancer (搜索) in June.
A Chinese-developed immunotherapy regimen could offer patients with resectable gastric cancer (搜索) a new treatment option that improves clinical outcomes while reducing their exposure to chemotherapy, medical experts announced at a recent conference in Beijing.
The regimen, based on the Phase 3 ASTRUM-006 study, combines serplulimab, an anti-PD-1 (搜索) monoclonal antibody developed by Shanghai Henlius Biotech (搜索), with chemotherapy before surgery, followed by serplulimab alone after surgery. The approach eliminates the need for postoperative chemotherapy among selected patients, potentially reducing treatment-related toxicity and improving adherence and quality of life, experts said at the inaugural conference on innovation in perioperative immunotherapy for gastric cancer (搜索).
Disease Burden and Unmet Need
Gastric cancer (搜索) remains a major public health challenge in China. The country recorded about 342,000 new cases and 249,000 deaths from the disease in 2024, according to data from the National Cancer Center. Although surgery remains the cornerstone of treatment for resectable gastric cancer, microscopic cancer cells can remain after surgery and lead to recurrence, making treatment administered before and after an operation critical to improving long-term outcomes.
Trial Design and Key Findings
ASTRUM-006 was a randomized, double-blind, placebo-controlled, multicenter Phase 3 trial involving patients with previously untreated, resectable gastric or gastroesophageal junction adenocarcinoma (搜索) whose tumors had a PD-L1 (搜索) combined positive score of at least five.
Results showed that neoadjuvant serplulimab plus chemotherapy, followed by postoperative serplulimab monotherapy, reduced the risk of disease progression, recurrence, a new malignancy or death by 33 percent compared with conventional perioperative chemotherapy, based on an independent central review.
Shen Lin, a professor at Peking University Cancer Hospital and a leading investigator of the study, said the trial provided clinical evidence addressing the characteristics and treatment needs of Chinese patients.
"The results demonstrate that selected patients can avoid chemotherapy after surgery without compromising treatment efficacy, offering a potential path toward balancing longer survival with better quality of life," she said.
Regulatory Milestone and Industry Perspective
China's National Medical Products Administration approved the serplulimab-based regimen for perioperative treatment of gastric cancer (搜索) in June.
Jason Zhu, executive director and CEO of Shanghai Henlius Biotech (搜索), said the company would continue to develop treatment options that balance clinical efficacy with patients' quality of life.
"In the past, gastric cancer (搜索) patients had to bear a heavy chemotherapy burden," Zhu said. "Today, the new regimen offers a chemotherapy-sparing option and moves treatment toward longer, higher-quality survival."