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Attend this session at the
2019 ASCO Annual Meeting!

Session: Lung Cancer—Non-Small Cell Metastatic

Type: Poster Session

Time: Sunday June 2, 8:00 AM to 11:00 AM

Location: Hall A

The CANOPY program: Canakinumab in patients (pts) with non-small cell lung cancer (NSCLC).

Metastatic Non-Small Cell Lung Cancer

Lung Cancer—Non-Small Cell Metastatic

2019 ASCO Annual Meeting

Abstract No:

Poster Board Number:
Poster Session (Board #442a)

J Clin Oncol 37, 2019 (suppl; abstr TPS9124)

Author(s): Luis G. Paz-Ares, Edward B. Garon, Andrea Ardizzoni, Fabrice Barlesi, Byoung Chul Cho, Gilberto Castro, Pedro De Marchi, Enriqueta Felip, Yasushi Goto, Alastair Greystoke, Shun Lu, Darren Wan Teck Lim, Vassiliki Papadimitrakopoulou, Martin Reck, Benjamin J. Solomon, David R. Spigel, Daniel Shao-Weng Tan, Michael Thomas, James Chih-Hsin Yang, Bruce E. Johnson; University Hospital 12 de Octubre, Madrid, Spain; David Geffen School of Medicine, University of California/TRIO-US Network, Los Angeles, CA; St. Orsola-Malpighi University Polyclinic, Bologna, Italy; Aix-Marseille University, Marseille, France; Yonsei University College of Medicine, Seoul, South Korea; Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil; Hospital de Câncer de Barretos, São Paulo, Brazil; Vall d’Hebron Institute of Oncology, Barcelona, Spain; National Cancer Center Hospital, Department of Thoracic Oncology, Tokyo, Japan; Newcastle upon Tyne Hospitals, Newcastle, United Kingdom; Shanghai Chest Hospital, Jiao Tong University, Shanghai, China; National Cancer Center Singapore, Singapore, Singapore; University of Texas MD Anderson Cancer Center, Houston, TX; LungenClinic, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany; Peter MacCallum Cancer Centre, Melbourne, VIC, Australia; Sarah Cannon Research Institute and Tennessee Oncology, Nashville, TN; National Cancer Centre Singapore, Singapore, Singapore; Internistische Onkologie der Thoraxtumoren, Thoraxklinik im Universitätsklinikum Heidelberg, Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany; Graduate Institute of Oncology, National Taiwan University College of Medicine, Taipei, Taiwan; Dana-Farber Cancer Institute, Boston, MA

Abstract Disclosures


Background: Inflammatory pathways can be pro-tumorigenic or anti-tumorigenic. The cytokine interleukin-1β (IL-1β) can promote the infiltration of immunosuppressive cells into the tumor microenvironment leading to a pro-tumorigenic microenvironment that promotes carcinogenesis, tumor invasiveness, and immunosuppression. Canakinumab is a human monoclonal antibody that binds and neutralizes IL-1β. Previous clinical data (CANTOS study) has shown that canakinumab could significantly reduce lung cancer incidence and mortality. This data along with the preclinical results that IL-1β does support tumorigenic inflammation provide the rationale to investigate the therapeutic role of canakinumab in lung cancer. Methods: Three Phase 3 trials have been designed in parallel to evaluate canakinumab in NSCLC (Table). Clinical trial information: NCT03447769, NCT03631199, NCT03626545

Study designProspective, multicenter, randomized, double-blind, placebo controlled
Two parts: Part 1 (open-label, safety run-in) and Part 2 (randomized, placebo controlled)
Population*Stages IIA-IIIA and IIIB (T > 5cm N2) completely resectedPreviously untreated stage IIIB/IIIC-IV squamous and non-squamousPreviously treated with PD-(L)1 inhibitors and CTx, stage IIIB-IV
Treatment arms and randomization1:1 to canakinumab or placeboPart 2 - 1:1 to canakinumab or placebo + platinum-chemotherapy (CTx) + pembrolizumabPart 2 - 1:1 to canakinumab or placebo + docetaxel
Estimated enrollment1500 ptsPart 1: ≈27 pts (3 cohorts of ≈9 pts each, based on different CTx)
Part 2: 600 pts
Part 1: ≈9 pts
Part 2: 226 pts
StratificationStage, histology and geographic regionPD-L1 status, geographic region and histologyNumber of prior lines of therapy and histology
Treatment schemeCanakinumab 200 mg Q3W, s.c.
18 cycles of treatment4 cycles of induction (canakinumab or placebo + CTx + pembrolizumab), followed by maintenance (canakinumab or placebo + pembrolizumab ± pemetrexed) until progressive disease (PD)treated until PD
Primary endpointsDisease free survivalPart 1: incidence of dose limiting toxicity (DLT) in first 42 days of treatment
Part 2: PFS and OS
Part 1: incidence of DLT in first 42 days of treatment
Part 2 : OS

*stages as per AJCC/UICC v.8

Other Abstracts in this Sub-Category:


1. Association of STK11/LKB1 genomic alterations with lack of benefit from the addition of pembrolizumab to platinum doublet chemotherapy in non-squamous non-small cell lung cancer.

Meeting: 2019 ASCO Annual Meeting Abstract No: 102 First Author: Ferdinandos Skoulidis
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


2. Real-world outcomes of patients with advanced non-small cell lung cancer (aNSCLC) and autoimmune disease (AD) receiving immune checkpoint inhibitors (ICIs).

Meeting: 2019 ASCO Annual Meeting Abstract No: 110 First Author: Sean Khozin
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer


3. RELAY: A multinational, double-blind, randomized Phase 3 study of erlotinib (ERL) in combination with ramucirumab (RAM) or placebo (PL) in previously untreated patients with epidermal growth factor receptor mutation-positive (EGFRm) metastatic non-small cell lung cancer (NSCLC).

Meeting: 2019 ASCO Annual Meeting Abstract No: 9000 First Author: Kazuhiko Nakagawa
Category: Lung Cancer—Non-Small Cell Metastatic - Metastatic Non-Small Cell Lung Cancer