Perioperative serplulimab with neoadjuvant chemotherapy versus perioperative chemotherapy in PD-L1-positive gastric cancer (ASTRUM-006): a randomised, double-blind, multicentre, phase 3 study
Randomized trial shows improved event-free survival in PD-L1-positive gastric cancer, suggesting a better treatment option.
Key Points
This study aims to evaluate the efficacy and safety of perioperative serplulimab combined with neoadjuvant chemotherapy in PD-L1-positive gastric cancer.
Randomized, double-blind, multicentre phase 3 trial conducted at 75 hospitals in China and Thailand, NCT04139135.
Included patients aged 18-70 with PD-L1 CPS ≥5 and resectable gastric adenocarcinoma assigned 1:1 to serplulimab or placebo plus SOX chemotherapy.
Primary endpoint was event-free survival assessed in PD-L1 CPS ≥10 and intention-to-treat populations.
Median event-free survival significantly longer with serplulimab than with placebo in PD-L1 CPS ≥10 (NR vs 42.0 months; HR 0.65, 95% CI 0.47-0.90; p=0.0082).
In intention-to-treat population, event-free survival was also significantly longer with serplulimab (NR vs 35.9 months; HR 0.73, 95% CI 0.56-0.94; p=0.015).
Grade 3 or worse treatment-related adverse events were fewer in the serplulimab group compared to the placebo group (47% vs 59%).