Multinational phase 2 trial of first-line nivolumab and relatlimab plus chemotherapy for gastric or gastroesophageal junction adenocarcinoma

The multinational phase 2 RELATIVITY-060 study randomized patients with previously untreated advanced adenocarcinoma of stomach or gastroesophageal junction (aGC/GEJC) 1:1 to nivolumab (anti-PD-1) plus relatlimab (anti-LAG-3) and chemotherapy (n=138) or nivolumab plus chemotherapy (n=136). Median follow-up was 11.9 months. Among patients with LAG-3 expression ≥ 1%, the ORR (primary endpoint) was 48% in the nivolumab plus relatlimab plus chemotherapy group versus 61% in the nivolumab plus chemotherapy group; median progression-free survival was 7.0 versus 8.3 months; and median overall survival was 13.5 versus 16.0 months. Grade 3 or 4 treatment-related adverse events occurred in 69% and 61%, and discontinuation because of TRAEs in 42% and 36% in the two arms, respectively. The authors conclude that addition of relatlimab to first-line nivolumab plus chemotherapy did not improve outcomes among aGC/GEJC patients with LAG-3 expression > 1%.