Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study - PubMed
3 hours ago
- #Clinical Trial
- #Gastric Cancer
- #Immunotherapy
- ASTRUM-006 was a phase 3 study comparing perioperative serplulimab (anti-PD-1) plus SOX chemotherapy vs. placebo plus SOX in PD-L1-positive resectable gastric/gastro-oesophageal junction adenocarcinoma.
- In patients with PD-L1 CPS ≥10, serplulimab significantly improved event-free survival (median not reached vs. 42.0 months; HR 0.65, p=0.0082).
- In the intention-to-treat population (CPS ≥5), serplulimab also significantly improved event-free survival (median not reached vs. 35.9 months; HR 0.73, p=0.015).
- Serplulimab had a better safety profile, with fewer grade 3+ treatment-related adverse events (47% vs. 59%) and fewer treatment discontinuations due to adverse events (7% vs. 11%).
- The study supports perioperative serplulimab plus SOX as an effective and safer option for this patient population, though overall survival data require further follow-up.