Hypothesis
The five-peptide cancer vaccine S-588410, given after curative resection of HLA-A*24:02-positive, node-positive esophageal squamous cell carcinoma, would prolong relapse-free survival.
What failed
Among 276 randomised patients, median relapse-free survival was 84.3 weeks with the vaccine vs 84.1 with placebo (P = 0.8156), and overall survival did not differ (P = 0.6533). The primary endpoint was not met.
Broken assumption
Inducing cytotoxic T-lymphocyte responses against cancer-testis antigens delays relapse after curative resection.
Why
The vaccine did engage its target — cytotoxic T-lymphocyte induction in 132 of 134 patients within 12 weeks — but that immune response did not translate into longer relapse-free survival. The authors note longer survival among subgroups with high CTL intensity, upper thoracic tumours or grade 3 injection-site reactions.
From the published paper: Makino et al. Esophagus, 2024. ↗CC BY