Adjuvant Canakinumab Misses DFS End Point in R0 Resected Stage II-IIIA NSCLC

In an update to the phase 3 CANOPY-A trial, investigators reported that canakinumab did not significantly improve disease-free survival over placebo in patients with completely resected non–small cell lung cancer.

Treatment with canakinumab (ACZ885) did not result in a disease-free survival (DFS) improvement over placebo in patients with fully resected stage II to IIIA non–small cell lung cancer, according to a press release on updated findings from the phase 3 CANOPY-A trial (NCT03447769).

In light of this update, investigators reported that the trial missed its primary end point of DFS, although no unforeseen safety signals were observed. Data from the trial are due to read out at an upcoming medical meeting.

“We made an investment in the CANOPY program based on signals of reduced lung cancer incidence and mortality observed in the CANTOS study. These positive signals supported the study of canakinumab as adjuvant treatment for early lung cancer,” Jeff Legos, executive vice president, Global Head of Oncology & Hematology Development at Novartis, said in the press release. “While we are disappointed CANOPY-A did not show the benefit we hoped for, every trial generates scientific evidence that supports future research and development, and we look forward to continuing to pursue new therapeutic options for people living with lung cancer, whose needs remain urgent and significant. We thank the patients and clinical investigators whose time and commitment made this research possible.”

Canakinumab is a human monoclonal antibody with high-affinity and selective binding to human IL-1β, in turn inhibiting its activity by blocking connection with its receptor. Initial study findings indicated that the agent could suppress protumor inflammation, thus resulting in a boosted antitumor immune response, a reduction in tumor cell proliferation, and impairment of angiogenesis.

The multicenter, randomized, double-blind trial examined the safety and efficacy of canakinumab in a population of patients with stage II to IIIA and IIIB disease who had undergone an R0 resection. A total of 1382 patients enrolled on the trial and received either 200 mg of subcutaneous canakinumab every 3 weeks or matching placebo up to a year. Prior to randomization, patients received standard of care adjuvant cisplatin-based chemotherapy and radiation therapy.

Secondary study end points included overall survival in the entire cohort and in those stratified by PD-L1 and CD8, DFS in subgroups stratified by PD-L1 and CD8, and lung cancer–specific survival.

To enroll on the study, patients were required to have been treated with cisplatin-based chemotherapy and recovered from all toxicities related to previous treatment with systemic therapies. Patients also needed to have a performance status of 0 or 1.

Those with unresectable or metastatic disease who were treated with neoadjuvant therapy or who had presence or a history of another malignant disease were not eligible for enrollment. Other exclusion criteria included a history of cardiac disease, uncontrolled diabetes, or active or recurrent hepatic disorder.


Novartis provides update on Phase III CANOPY-A study evaluating canakinumab as adjuvant treatment in non-small cell lung cancer. News release. Novartis. August 15, 2022. Accessed August 15, 2022.