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Gregory J. Riely, MD, PhD


CANOPY-1: Adding Monoclonal Antibody to Immunotherapy Regimen in NSCLC

By: Kayci Reyer
Posted: Thursday, February 1, 2024

According to findings from the randomized phase III CANOPY-1 trial, presented in the Journal of Clinical Oncology, the addition of the monoclonal antileukin-1b (IL-1b) antibody canakinumab to standard first-line treatment did not appear to improve survival outcomes for patients with advanced non–small cell lung cancer (NSCLC). The study joined canakinumab with the immunotherapy regimen of the PD-1 inhibitor pembrolizumab and platinum-based chemotherapy.

“The CANOPY program was initiated on the basis of findings from the CANTOS study that showed a reduced incidence of NSCLC as early as 2 years after canakinumab intervention,” noted Bruce E. Johnson, MD, of Dana-Farber Cancer Institute, Boston, and colleagues.

The double-blind study included 643 patients with advanced or metastatic NSCLC without EGFR or ALK mutations. All patients received 200 mg of intravenous pembrolizumab once every 3 weeks plus platinum-based doublet chemotherapy. Additional treatment of 200 mg of subcutaneous canakinumab once every 3 weeks (n = 320) or placebo (n = 323) was randomly assigned.

At a median follow-up of 6.5 months, the median progression-free survival was 6.8 months for both groups. At a median follow-up of 21.2 months, the median overall survival was comparable between the arms, at 20.8 months with canakinumab vs 20.2 months without it. Shorter progression-free survival and overall survival seemed to be associated with higher baseline C-reactive protein and IL-6 levels.

No notable difference in infection rates was observed between the arms, according to the investigators. Neutropenia and alanine transaminase (ALT) increases of grade 2 or less were reported more frequently with the canakinumab combination therapy. Disease symptoms such as chest pain, coughing, and dyspnea were significantly delayed in the treatment arm.

“Biomarker data from the CANOPY studies may help identify patient populations that could benefit from IL-1β–targeted therapies,” the authors concluded.

Disclosures: For full disclosures of the study authors, visit

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