Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non–Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial
Edward B. Garon, Shun Lü, Yasushi Goto, Pedro De Marchi, Luis Paz‐Ares, David R. Spigel, Michael Thomas, James Chih‐Hsin Yang, Andrea Ardizzoni, Fabrice Barlési, С. В. Орлов, Hiroshige Yoshioka, Giannis Mountzios, Sadhvi Khanna, Claudia Bossen, Mariana Carbini, Sabine Turri, Andrea P. Myers, Byoung Chul Cho
Abstract
PURPOSE: Effective treatments for resectable non-small-cell lung cancer (NSCLC) are limited and relapse rates are high. The interleukin (IL)-1β pathway has been linked with tumor development and progression, including in the Canakinumab Anti-Inflammatory Thrombosis Outcomes cardiovascular study in which IL-1β pathway inhibition with canakinumab reduced lung cancer incidence and mortality in an exploratory analysis. METHODS: CANOPY-A (ClinicalTrials.gov identifier: NCT03447769) is a phase III, randomized, double-blind, multicenter study of canakinumab versus placebo for adult patients with stage II-IIIA or IIIB (T >5 cm, N2-positives II-IIIB; American Joint Committee on Cancer/Union for International Cancer Control version 8), completely resected NSCLC who had received adjuvant cisplatin-based chemotherapy. The primary end point was disease-free survival (DFS) and the key secondary end point was overall survival (OS). RESULTS: = .258). DFS subgroup analyses did not show any meaningful differences between arms. As expected, because of canakinumab-driven IL-1β pathway inhibition, C-reactive protein and IL-6 levels decreased in the canakinumab arm versus placebo arm, but had no correlation with differential clinical outcomes. OS was not formally tested as DFS was not statistically significant. CONCLUSION: CANOPY-A did not show a DFS benefit of adding canakinumab after surgery and adjuvant cisplatin-based chemotherapy in patients with resected, stage II-III NSCLC. No new safety signals were identified with canakinumab.