Abstract CT255: Canakinumab as adjuvant therapy in patients with completely resected non-small cell lung cancer: CANOPY-A trial
Authors: Alexander Spira, Andrea Ardizzoni, Fabrice Barlesi, Byoung Chul Cho, Pedro De Marchi, Yasushi Goto, Dariusz Kowalski, Shun Lu, Luis Paz-Ares, David R. Spigel, Michael Thomas, Sabine Turri, Vanessa Rodrik-Outmezguine, Wen Zhou, Terri Kreisl, James Chih-Hsin Yang, Edward B. Garon
Journal: Cancer Research (2021)

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 (hsCRP) 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 &amp;gt;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 disease-free survival (DFS) 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&amp;gt;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 postsurgery 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 October 19, 2020, there are 356 study locations. Citation Format: Alexander Spira, Andrea Ardizzoni, Fabrice Barlesi, Byoung Chul Cho, Pedro De Marchi, Yasushi Goto, Dariusz Kowalski, Shun Lu, Luis Paz-Ares, David R. Spigel, Michael Thomas, Sabine Turri, Vanessa Rodrik-Outmezguine, Wen Zhou, Terri Kreisl, James Chih-Hsin Yang, Edward B. Garon. Canakinumab as adjuvant therapy in patients with completely resected non-small cell lung cancer: CANOPY-A trial [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT255.