For patients with curatively resectable non-small cell lung cancer (NSCLC), immune checkpoint inhibition prior to surgery with nivolumab and relatlimab is safe and feasible.

This data was presented on Friday, September 9, 2022, at the European Society for Medical Oncology Congress in Paris, France, by first author, Martin Schuler, MD, department of medical oncology, University Hospital Essen, Essen, Germany.

In this phase 2 study, 60 patients with NSCLC stage IB, II, or IIIA were enrolled between March 4, 2020, and Jul 15, 2020. Patients were randomized on a 1:1 basis to receive either 2 preoperative doses, once every 2 weeks, of 240 mg nivolumab (n = 30), or nivolumab plus 80 mg relatlimab (n = 30). The primary end point was feasibility of curatively intended surgery within 43 days of the part of the immune checkpoint inhibition treatment. Secondary end points included pathological and radiological response rates, disease-free and overall survival rates (DFS, OS), and safety.

All patients included in this evaluation met the primary end point. The R0 resection rate was 98%, excluding 2 patients who were found to have pleural carcinosis that had not been detected via preoperative imaging. Across both arms, the 12-month OS rate was 96% (95% confidence interval [CI], 83% to 99%) and the DFS rate was 91% (95% CI, 78% to 97%). According to RECIST criteria, radiological response rates were 11% for the nivolumab only arm and 27% in the nivolumab plus relatlimab arm. Complete or major histopathological response rates were 28% in the nivolumab only arm compared to 32% in the nivolumab plus relatlimab arm. Less than 50% of vital tumor cells were observed in 60% of patients treated with nivolumab only and 71% of patients treated with nivolumab plus relatlimab.

Adverse events related to the preoperative immune checkpoint inhibition were as expected, with grade ≥3 events seen in 4 patients treated with nivolumab only and 2 patients with nivolumab plus relatlimab. In the nivolumab arm, there were 2 patients who died within 90 days of surgery.

Dr Schuler and colleagues added that the “high histopathological response rates indicate clinical efficacy, which merits further study supplementing with biomarker analyses for future patients selection.

Source:

Schuler MHH, Cuppens K, Ploenes T, et al. “A randomized, multicentric phase II study of preoperative nivolumab plus relatlimab or nivolumab in patients with resectable non-small cell lung cancer (NEOpredict-Lung).” Presented at European Society for Medical Oncology Congress; September 9-13, 2022. Paris, France.