Canakinumab does not improve SSM in patients with NSCLC

The CANOPY-A phase study did not achieve its primary objective of improving disease-free survival in patients with completely resected stage II to IIIA and IIIB non-small cell lung cancer.

The Phase 3 CANOPY-A trial (NCT03447769) did not meet its primary endpoint of disease-free survival (DFS) versus placebo, according to Novartis. The CANOPY-A study evaluated the adjuvant treatment of patients with completely resected (R0) stages II to IIIA and IIIB (T > 5 cm N2) non-small cell lung cancer (NSCLC).1

The investigational drug was canakinumab (ACZ885), an interleukin-1beta (IL-1β) inhibitor. No new safety signals were observed, and further results from the trial will be presented at a future meeting.

“We invested in the CANOPY program based on the signals of reduced lung cancer incidence and mortality observed in the CANTOS study. These positive signals supported the study of canakinumab as an adjuvant therapy for early lung cancer,” said Jeff Legos, executive vice president, global head of oncology and hematology development at Novartis. “While we are disappointed that CANOPY-A did not show the benefits we hoped for, each trial generates scientific evidence that supports future research and development, and we look forward to continuing to seek new therapeutic options for patients. people with lung cancer, whose needs remain. urgent and important. We thank the patients and clinical researchers whose time and commitment made this research possible.

Investigators of this multicenter, double-blind, Phase 3 study randomized 1,382 patients with NSCLC 1:1 to receive either canakinumab 200 mg subcutaneously every 3 weeks or a matching placebo for up to 1 year . Prior to randomization, these patients received standard adjuvant cisplatin-based chemotherapy and radiation therapy, if available.

The primary endpoint of the study, which was not met, was SSM, and secondary endpoints included overall survival, SSM in PD-L1 subgroups, SSM in CD8 subgroups, lung cancer-specific survival, and observed maximum plasma concentration of canakinumab.2

Patients were eligible if they had (R0) stage II-IIIA and IIIB NSCLC or stage II-IIIA, IIIB NSCLC and were candidates for complete resection surgery. Other patient inclusion criteria include mandatory cisplatin-based chemotherapy, complete recovery from all toxicities related to prior systemic therapy, and an ECOG performance score of 0 or 1.

Exclusion criteria include patients who have unresectable or metastatic disease, positive microscopic margins on the pathology report and/or macroscopic disease remaining at the time of surgery, have received neoadjuvant therapy, have the presence or history of malignant disease, other than NSCLC resection, that has been diagnosed and/or required treatment within the last 3 years, have history of current diagnosis of heart disease, uncontrolled diabetes, active liver disorder or known recurring. Additionally, subjects must be evaluated for TB and those with active TB are not eligible.2

Canakinumab is a human monoclonal antibody that binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity.

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