Dr Spicer on Surgical Considerations After Approval of Perioperative Nivolumab in Resectable NSCLC

Jonathan D. Spicer, MD, PhD, FRCS, thoracic surgical oncologist, Division of Adult Thoracic Surgery, associate professor, Department of Surgery, Faculty of Medicine and Health Sciences, McGill University, director, McGill University Health Center (MUHC) Thoracic Oncology Network, discusses surgical implications for patients with resectable non–small cell lung cancer (NSCLC) following the recent FDA approval of perioperative nivolumab (Opdivo).

On October 3, 2024, the regulatory agency approved nivolumab in combination with platinum-doublet chemotherapy as a neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant therapy, for adult patients with resectable NSCLC with tumors of at least 4 cm and/or node-positive disease who do not harbor EGFR mutations or ALK rearrangements.

The approval was supported by data from the phase 3 CheckMate 77T trial (NCT04025879), which showed that the median event-free survival (EFS) was not reached (95% CI, 28.9-not estimable) in the nivolumab arm vs 18.4 months (95% CI, 13.6-28.1) in the chemotherapy arm (HR, 0.58; 95% CI, 0.43-0.78; P = .00025).

Spicer begins by noting that CheckMate 77T study authors adequately defined the populations treated in the trial, which included patients who may not have been traditionally considered for surgical resection. Specifically, the study featured patients with N2 involvement, including those with multi-station N2 involvement, Spicer explains.

In an exploratory analysis of CheckMate 77T presented at the 2024 ASCO Annual Meeting, findings showed that perioperative nivolumab demonstrated a clinical benefit vs chemotherapy alone in both patients with clinical stage III N2 disease (HR, 0.46) and those with stage III non-N2 disease (HR, 0.60).

Patients with N2 disease, particularly those with multi-station N2 involvement, have traditionally been treated with definitive chemoradiation followed by durvalumab (Imfinzi), Spicer explains, noting that surgery has been a less common option in these cases. The data from CheckMate 77T show the potential benefit of a surgical approach for patients with N2 disease, particularly when it is combined with perioperative nivolumab, Spicer concludes.