Analysis of association between pathologic response and event-free survival after neoadjuvant therapy for non-small cell lung cancer

A prespecified analysis of results of the phase 3 CheckMate 816 trial (neoadjuvant nivolumab plus platinum-based chemotherapy versus platinum-based chemotherapy alone for resectable stage IB-IIIA non-small cell lung cancer) found that the percentage residual viable tumor (RVT) in primary tumor after neoadjuvant therapy predicted event-free survival (EFS) improved with 0% versus > 0% RVT in primary tumor (HR 0.18). In the nivolumab plus chemotherapy group, regardless of lymph node involvement, EFS Two-year EFS rates were 90%, 60%, 57%, and 39% for patients with RVT 0%-5%, >5%-30%, >30%-80%, and >80%, respectively. Each 1% RVT associated with a 0.017 HR increase for EFS. When compared to radiographic response and ctDNA clearance, %RVT best approximated EFS. The authors conclude that these findings support pathologic response as an emerging survival surrogate.