Curative surgery for non-small cell lung cancer (NSCLC) following treatment with nivolumab plus relatlimab is as safe as surgery after nivolumab alone, according to study results presented at the ASCO Annual Meeting 2023.
The perioperative course, morbidity, and mortality rates with nivolumab plus relatlimab are comparable to those seen with other neoadjuvant regimens, said study presenter Clemens Aigner, MD, of the West German Cancer Center at University Medicine Essen in Germany.
In the phase 2 NEOpredict-Lung study (ClinicalTrials.gov Identifier: NCT04205552), Dr Aigner and colleagues evaluated 60 patients with resectable stage IB-IIIA NSCLC. The patients were randomly assigned to receive either nivolumab (240 mg; n=30) or the combination of nivolumab (240 mg) plus relatlimab (80 mg; n=30), followed by surgery and standard adjuvant therapy.
Response rates were similar between the arms. The pathologic complete response rate was 13.3% in the nivolumab monotherapy arm and 16.7% in the nivolumab-relatlimab arm. The major pathologic response rate was 27% with monotherapy and 30% with combination treatment.
In the overall cohort, the 12-month overall survival (OS) rate was 96%, and the 12-month disease-free survival (DFS) rate was 91%. There were no significant differences in OS or DFS between the arms. There were no deaths within 30 days in either arm.
The perioperative complication rate was 33.3% for the nivolumab monotherapy arm and 26.6% for the nivolumab-relatlimab arm. The rate of intraoperative complications was 3% for each arm.
The most common perioperative complications were atrial fibrillation in the nivolumab monotherapy arm (10%) and prolonged air leak in the nivolumab-relatlimab arm (10%). One patient in the monotherapy arm had a pulmonary embolism.
The median duration of postsurgical hospital stay was statistically comparable but numerically longer for the nivolumab monotherapy arm (7 days) than for the nivolumab-relatlimab arm (5.5 days).
The study protocol has since been amended to include a second relatlimab dose, and correlative studies and biomarker analyses are ongoing, Dr Aigner said.
Disclosures: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Aigner C, Du Pont B, Hartemink K, et al. Surgical outcomes of patients with resectable non-small-cell lung cancer receiving neoadjuvant immunotherapy with nivolumab plus relatlimab or nivolumab: Findings from the prospective, randomized, multicentric phase II study NEOpredict-Lung. ASCO 2023. June 2-6, 2023. Abstract 8500.