Janjigian YY, et al. - Researchers performed a study to test the safety as well as the efficacy of nivolumab and nivolumab plus ipilimumab in Western patients with chemotherapy-refractory esophagogastric cancers. According to the findings, clinically meaningful antitumor activity, durable responses, encouraging long-term overall survival (OS), and a manageable safety profile in patients with chemotherapy-refractory esophagogastric cancer was see with nivolumab and nivolumab plus ipilimumab.

Methods

• For this investigation, patients with locally advanced or metastatic chemotherapy–refractory gastric, esophageal, or gastroesophageal junction cancer from centers in the US and Europe received nivolumab or nivolumab plus ipilimumab.
• Objective response rate was the primary end point.
• The relationship of tumor programmed death-ligand 1 status with response and survival was also assessed.

Results

• As per data, of 160 treated subjects (59 with nivolumab 3 mg/kg, 49 with nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, 52 with nivolumab 3 mg/kg plus ipilimumab 1 mg/kg), 79% had received two or more prior therapies.
• At the data cutoff, investigator-assessed objective response rates were 12% (95% CI, 5% to 23%), 24% (95% CI, 13% to 39%), and 8% (95% CI, 2% to 19%) in the three groups, respectively.
• Regardless of tumor programmed death-ligand 1 status, responses were observed.
• It was noted that with a median follow-up of 28, 24, and 22 months across the 3 groups, 12-month progression-free survival rates were 8%, 17%, and 10%, respectively; 12-month OS rates were 39%, 35%, and 24%, respectively.
• Findings revealed that treatment-related grade 3/4 adverse events were reported in 17%, 47%, and 27% of patients in the three groups, respectively.