Abstract LBA039: Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small Cell Lung Cancer: CANOPY-A Trial

Abstract

Abstract Background: In the CANTOS study, canakinumab (selective interleukin 1β inhibitor) treatment was associated with reduced incidence and mortality from non-small cell lung cancer (NSCLC) in stable post–myocardial infarction patients with elevated high-sensitivity C-reactive protein (hs-CRP) levels. The CANOPY-A study was designed to investigate the therapeutic role of canakinumab in NSCLC. Methods: The CANOPY-A study (NCT03447769) is evaluating the efficacy and safety of canakinumab as adjuvant therapy in adult patients with completely resected NSCLC. Patients with American Joint Committee on Cancer/Union for International Cancer Control version 8 stage IIA-IIIA and IIIB (T >5 cm, N2), any histology, completely resected (R0) NSCLC and completion of adjuvant cisplatin-based chemotherapy (≥2 cycles) and radiotherapy (if applicable) are eligible. Patients must not have had prior neoadjuvant chemotherapy or radiotherapy. Patients (~1500) are randomized 1:1 to receive canakinumab (200 mg) or placebo subcutaneously every 3 weeks for 18 cycles or until disease recurrence as determined by investigator, unacceptable toxicity, or treatment discontinuation at the discretion of the investigator. The primary objective is to compare disease-free survival (DFS) in the canakinumab versus placebo arm per local investigator assessment. Secondary objectives are overall survival (OS), lung cancer–specific survival, safety, pharmacokinetics, immunogenicity, and patient-reported outcomes. Adult patients with stage IIA-IIIA and IIIB (T>5 cm, N2 disease only) NSCLC who are candidates for complete resection surgery (and therefore prospective candidates for the main study) will be asked to participate in a biomarker substudy to understand how resection may impact biomarkers involved in the interleukin 1β inflammatory pathway and mutations present in blood. In the substudy, the levels of hs-CRP, other cytokines, and additional biomarkers in blood will be assessed before and after surgery (endpoint: summary statistics of hs-CRP and other pharmacodynamic biomarkers). For patients who will enroll in the main study, possible associations between pre- and post-surgery biomarker levels with canakinumab efficacy will be assessed (endpoint: DFS and OS by hs-CRP and other pharmacodynamic biomarkers). The CANOPY-A study is currently enrolling. As of August 6, 2021, there are 399 study locations. Citation Format: Edward B. Garon, Andrea Ardizzoni, Fabrice Barlesi, Byoung Chul Cho, Pedro De Marchi, Yasushi Goto, Dariusz Kowalski, Shun Lu, David R. Spigel, Michael Thomas, James Chih-Hsin Yang, Sabine Turri, Wen Zhou, Teri Kreisl, Luis Paz-Ares. Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non-Small Cell Lung Cancer: CANOPY-A Trial [abstract]. In: Proceedings of the AACR-NCI-EORTC Virtual International Conference on Molecular Targets and Cancer Therapeutics; 2021 Oct 7-10. Philadelphia (PA): AACR; Mol Cancer Ther 2021;20(12 Suppl):Abstract nr LBA039.