Neoadjuvant nivolumab plus ipilimumab in resectable lung cancer

The international phase III Check-Mate 816 trial demonstrated statistically significant improvement with neoadjuvant nivolumab plus chemotherapyversus neoadjuvant chemotherapy in event-free survival and pathologic complete response for resectable non–small cell lung cancer (NSCLC); a new exploratory analysis of the data suggests potential long-term clinical benefit with neoadjuvant nivolumab plus ipilimumab, as reported recently on Thoracic Oncology.

Data come from 221 patients randomly assigned to nivolumab plus ipilimumab or chemotherapy; at a median follow-up of 49.2 months, the median event-free survival was 54.8 months with nivolumab plus ipilimumab and chemotherapy versus 20.9 months with chemotherapy only, and 3-year event-free survival rates were 56% versus 44%. 3-year overall survival rates were 73% versus 61% and pathologic complete response rates were 20.4% versus 4.6%, respectively. The safety profile of neoadjuvant nivolumab plus ipilimumab was consistent with previous reports in NSCLC, with low rates of high-grade toxicity. As authors point out, «Early detriment was seen with nivolumab plus ipilimumab for both event-free survival and overall survival during the first 9 months»; Thomas E. Stinchcombe, associate editor of the Journal of Clinical Oncology, thus wrote that «Despite the activity observed with nivolumab and ipilimumab in this exploratory analysis, the higher rate of early event-free survival events preclude its use in routine clinical care. Additional studies are needed to refine the patient population». Authors conclude that «Biomarkers that can identify patients who will benefit from neoadjuvant immunotherapy are of high clinical interest. On the basis of earlier reports from CheckMate 816, nivolumab plus chemotherapy remains the standard neoadjuvant treatment for eligible patients with resectable NSCLC».