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Phase 3 ASTRUM-006 evaluates biomarker-driven perioperative serplulimab strategy in resectable gastric or GEJ adenocarcinoma

In PD-L1 CPS ≥5 disease, the phase 3 study reported improved event-free survival and pathological complete response with neoadjuvant serplulimab plus chemotherapy followed by adjuvant serplulimab monotherapy versus neoadjuvant and adjuvant chemotherapy.

  • Lin Shen, MD; Xiaotian Zhang, MD; Ke Ji, MD; Linzhi Lu, MD; Quan Wang, MD; Quanlin Guan, MD; et al.

  • June 1, 2025

  • The Lancet
  • The Lancet, Volume 407, Issue 10547, Pages 2542–2553
  • 10.1016/S0140-6736(26)00974-8

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Evidence before this study

We searched PubMed from database inception up to April 7, 2026, with the terms (resectable gastric cancer OR GEJ adenocarcinoma) AND (perioperative OR neoadjuvant AND adjuvant) AND (phase 3) AND (phase III). A total of 44 reports from prospective clinical trials were listed and we identified three phase 3 studies (CheckMate 577, KEYNOTE-585, and MATTERHORN) that investigated the use of PD-1 or PD-L1 inhibitors as perioperative treatment for resectable gastric cancer or gastroesophageal junction adenocarcinoma. CheckMate 577 demonstrated the clinical benefit of adjuvant nivolumab in oesophageal or gastro-oesophageal junction cancer. Results from the other two studies were mixed: KEYNOTE-585 failed to achieve its primary endpoint, whereas MATTERHORN demonstrated positive results in the perioperative setting, suggesting the need for more precise therapeutic approaches and better patient selection to optimise clinical outcomes. The ASTRUM-006 study targets a more defined patient population and investigates a chemotherapy-sparing adjuvant strategy: neoadjuvant serplulimab (a PD-1 inhibitor) combined with chemotherapy, followed by adjuvant serplulimab monotherapy, in patients with PD-L1-positive gastric or gastro-oesophageal junction adenocarcinoma.

Added value of this study

ASTRUM-006 is the first study to specifically enrol patients based on PD-L1 combined positive score ≥5 and investigate the use of mono-immunotherapy in the adjuvant setting for gastric cancer. The results show that, compared with neoadjuvant and adjuvant chemotherapy, the chemotherapy-sparing adjuvant strategy following neoadjuvant immunotherapy plus chemotherapy significantly improves event-free survival and pathological complete response rate along with improved tolerability. These findings suggest its potential for the perioperative treatment of this indication.

Implications of all the available evidence

Along with accumulating evidence to support the integration of immune checkpoint blockade into perioperative treatment for resectable gastric and gastro-oesophageal junction cancer, these findings represent some of the first evidence that a less intensive, biomarker-driven treatment strategy involving a PD-1 antibody can be effectively applied in this setting.

Source: The Lancet

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