In an update of a Chinese phase II trial (NEOSUMMIT-01) reported in the Journal of Clinical Oncology, Nie et al found that the addition of the anti–PD-1 antibody toripalimab to perioperative chemotherapy improved 3-year event-free and overall survival in patients with locally advanced gastric or gastroesophageal junction cancer.
The prior report from the trial indicated that the addition of perioperative toripalimab improved pathologic responses in this setting.
Study Details
In the open-label multicenter trial, 108 patients received three cycles of preoperative chemotherapy followed by surgery and five postoperative cycles of investigator's choice of chemotherapy (n = 54) with SOX (S-1 and oxaliplatin) or CapOX (capecitabine and oxaliplatin), or toripalimab plus SOX or CapOX (n = 54) followed by toripalimab for up to 6 months.
Key Findings
At data cutoff, median follow-up was 43.2 months (interquartile range = 36.6–53.7 months). Event-free survival at 3 years was 74.7% (95% confidence interval [CI] = 63.6%–87.7%) in the toripalimab group vs 56.2% (95% CI = 43.3%–73.0%) in the control group (hazard ratio [HR] = 0.51, 95% CI = 0.27–0.98, P = .044).
Overall survival at 3 years was 81.3% (95% CI = 71.4%–92.4%) in the toripalimab group vs 72.2% (95% CI = 61.2%–85.2%) in the control group (HR = 0.45, 95% CI = 0.21–0.95, P = .036).
Benefits with the addition of toripalimab were consistent across most predefined subgroups and were maintained in an analysis excluding patients with mismatch repair–deficient disease.
The investigators concluded: “…[P]erioperative toripalimab plus chemotherapy significantly improved 3-year [event-free survival and overall survival] compared with chemotherapy alone, suggesting it as a promising treatment option for patients with locally advanced gastric or gastroesophageal junction cancer.”
Shu-Qiang Yuan, MD, PhD, of Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Guangzhou, China, is the corresponding author for the Journal of Clinical Oncology article.
DISCLOSURE: The study was supported by Shanghai Junshi Biosciences, National Natural Science Foundation of China, and others. For full disclosures of the study authors, visit ascopubs.org.
