Neoadjuvant Nivolumab Plus Ipilimumab Versus Chemotherapy in Resectable Lung Cancer

Area of Science:

• Medical Oncology
• Immunotherapy
• Thoracic Surgery

Background:

• Neoadjuvant immune checkpoint blockade is a promising strategy for non-small cell lung cancer (NSCLC).
• Limited randomized data exist for neoadjuvant nivolumab plus ipilimumab in resectable NSCLC.

Purpose of the Study:

• To report results from the exploratory, concurrently randomized arms of the CheckMate 816 trial.
• To compare neoadjuvant nivolumab plus ipilimumab with chemotherapy in resectable NSCLC.

Main Methods:

• Adults with stage IB-IIIA resectable NSCLC received neoadjuvant nivolumab plus ipilimumab or chemotherapy followed by surgery.
• Analyses included event-free survival (EFS), overall survival (OS), pathologic response, surgical outcomes, and safety.

Main Results:

• At median follow-up of 49.2 months, median EFS was 54.8 months with nivolumab plus ipilimumab vs. 20.9 months with chemotherapy.
• 3-year OS rates were 73% vs. 61%, and pathologic complete response rates were 20.4% vs. 4.6% favoring nivolumab plus ipilimumab.
• Grade 3-4 treatment-related adverse events were lower with nivolumab plus ipilimumab (14%) vs. chemotherapy (36%).

Conclusions:

• Neoadjuvant nivolumab plus ipilimumab demonstrated potential long-term clinical benefit in resectable NSCLC.
• The immunotherapy combination showed improved survival outcomes and pathologic response versus chemotherapy.
• Lower rates of high-grade toxicity were observed with neoadjuvant nivolumab plus ipilimumab.