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More Support for Nivolumab plus Chemotherapy in Gastric Cancer
Nivolumab combined with FOLFOX is approved for first-line treatment of metastatic gastroesophageal adenocarcinoma. Prior trials have shown improvements in progression-free survival (PFS), overall survival (OS), and response rate in patients with PDL-1 combined positive scores (CPS) ≥5%, with no clear survival benefit in patients with CPS <5% to 10%.
Investigators now report findings from ATTRACTION-4, an industry-sponsored, double-blind, placebo-controlled trial conducted in Asia that evaluated the addition of nivolumab to first-line S-1 or capecitabine plus oxaliplatin chemotherapy in patients with HER2-negative metastatic gastric cancer. Of 724 patients, 29% had prior gastrectomy, 18% received perioperative chemotherapy, 51% had diffuse cancers, and 16% had PDL-1 positivity >1% by tumor positive score (TPS). The primary endpoints were PFS and OS in all patients.
At a median follow-up of 11.6 months, median PFS was improved with nivolumab compared with placebo (10.5 vs. 8.3 months; hazard ratio, 0.68; P=0.0007). At a median follow-up of 26.6 months there was no difference in median OS between the nivolumab and placebo groups (17.5 and 17.2 months; HR, 0.90; P=0.26). The response rate was higher with nivolumab than placebo (57% vs. 48%) and median response duration was longer (12.9 vs. 8.7 months). Treatment-related grade 3/4 serious adverse events were slightly higher with nivolumab (18% vs. 14%).
ATTRACTION-4 adds to positive results for first-line use of a checkpoint inhibitor combined with chemotherapy in esophagogastric adenocarcinoma. The median overall survival in both treatment arms (17 months) was substantial, and crossover to treatment with a checkpoint inhibitor in the placebo arm (25%) and the high rate of patients treated with second-line therapy (72% and 73%) likely blunted a potential survival difference. The high rate of negative TPS score, which measures only tumor PDL-1 expression and likely overstates the rate of PDL-1–negative status, makes interpretation of the impact of PDL-1 expression in this trial unclear.
Kang Y-K et al.
Title: Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): A randomised, multicentre, double-blind, placebo-controlled, phase 3 trial.
Source: Lancet Oncol 2022 Feb 1; [e-pub]. (Abstract/FREE Full Text)