LAG-3 expression was significantly higher in responders to anti-PD-1 + anti-LAG-3 combination immunotherapy compared to non-responders (P = .0210; median = 1.0% in responders vs 0.25% in non-responders). The response rate was 84% (n = 27/32) in patients with LAG-3-positive tumors compared to 48% (n = 10/21) in patients with LAG-3-negative tumors....Next, we evaluated the association between LAG-3 expression, PFS and OS. Patients with LAG-3-positive tumors had a significantly longer PFS compared to patients with LAG-3-negative tumors (P = .0037)....In the current study, we demonstrated a significant association between LAG-3 expression and response to combination anti-LAG-3 + anti-PD-1 immunotherapy.