Multicenter phase 2 trial of neoadjuvant nivolumab with or without relatlimab in resectable non-small cell lung cancer

The phase 2 NEOpredict-Lung trial in Germany and Belgium evaluated two two-week cycles neoadjuvant nivolumab (anti-PD-1) with or without relatlimab (anti-LAG-3) followed by surgery and standard of care adjuvant therapy for stage IB to IIIA NSCLC. The primary study endpoint was feasibility of surgery within 43 days, which was met by all patients. Curative resection was achieve in 95% of patients. Major pathological (≤10% viable cells) and objective radiographic responses were achieved in 27% and 10% (nivolumab) and in 30% and 27% (nivolumab plus relatlimab) of patients, respectively. Disease-free survival and overall survival rates at 12 months were 89% and 93% (nivolumab) and 93% and 100% (nivolumab plus relatlimab). Both treatments were safe with grade ≥3 treatment-emergent adverse events observed in 10% (nivolumab) and 13% (nivolumab plus relatlimab) of patients. The authors conclude that the study showed feasibility and safety of dual targeting of PD-1 and LAG-3 before lung cancer surgery.