First-Line Nivolumab plus Ipilimumab for Advanced Non–Small-Cell Lung Cancer

In a prior phase I trial involving chemotherapy-naive patients with advanced non–small-cell lung cancer (NSCLC), first-line immunotherapy with nivolumab plus ipilimumab demonstrated clinical activity and tolerable toxicity (CheckMate 012; Lancet Oncol 2017; 18:31). Also, in a retrospective study involving NSCLC patients receiving immunotherapy, higher tumor mutation burden (TMB) was associated with improved response (NEJM JW Oncol Hematol Mar 2018 and J Clin Oncol 2018; 36:633).

Now, investigators have conducted an industry-funded, multipart, randomized, open-label, phase III trial (CheckMate 227) in which 1739 metastatic, mutation-negative, chemotherapy-naive NSCLC patients with high TMB (>10 mutations/Mb) received nivolumab plus ipilimumab…