Immunotherapy plus Chemotherapy Before Surgery Improves Outcomes in Lung Cancer

In the phase 3 industry-supported CheckMate 816 trial, researchers randomized 358 patients with stage IB to IIIA resectable non–small-cell lung cancer (NSCLC) to three cycles of platinum-doublet chemotherapy plus either the anti–PD-1 antibody nivolumab or placebo, followed by surgery. Eligible patients had no known activating mutations in the EGFR or ALK genes. Coprimary endpoints were event-free survival and pathologic complete response.

Median event-free survival was 31.6 months in the nivolumab-chemotherapy arm versus 20.8 months in the chemotherapy-alone arm (hazard ratio for disease progression, disease recurrence, or death, 0.63; P=0.005). Pathologic complete response was achieved by 24.0% of patients receiving nivolumab plus chemotherapy versus 2.2% of those receiving chemotherapy alone (odds ratio, 13.94; P<0.001). Both outcomes favored nivolumab plus chemotherapy across most key subgroups (e.g., disease stage, NSCLC histologic subtype, PD-L1 status, gender). The magnitude of the event-free survival benefit was greater in patients with stage IIIA disease than in those with stage IB or II disease and in patients with tumor PD-L1 expression ≥1% than in those with no PD-L1 expression. Moreover, more patients in the nivolumab-chemotherapy arm went on to receive definitive surgery (83.2% vs. 75.4%).