Multicenter phase 2 trial of first-line nivolumab plus low-dose ipilimumab for MSI-H advanced gastric or esophagogastric junction cancer

The multicenter phase 2 NO LIMIT trial in JAPAN evaluated the combination of nivolumab plus low-dose ipilimumab as first-line treatment for MSI-H advanced gastric or esophagogastric junction cancer (AGC). The overall response rate was 62.1% (95% CI 42-79.3) with complete response in 10.3%, whereas the disease control rate was 79.3% (60.3-92.0). The median progression-free survival was 13.8 months (95% CI 13.7-NR) and the median overall survival was NR, with a 12-month OS rate of 79.5%. Treatment-related adverse events occurred in 93.1% of patients, with grade ≥ 3 TRAEs in 37.9%. Discontinuation due to TRAEs occurred in 12 of 29 patients; however, in 11 of these 12 patients long-term antitumor efficacy was seen, with range of response duration 0.9+ to 15.6+ months.The authors conclude that nivolumab plus low-dose ipilimumab showed robust and durable antitumor efficacy as firs-line treatment for MSI-H AGC.