The phase CANOPY-A study has missed its primary end point of disease-free survival improvement in patients with stages II to IIIA and IIIB completely resected non-small cell lung cancer.
The phase 3 CANOPY-A trial (NCT03447769) did not meet its primary endpoint of disease-free survival (DFS) compared with placebo, according to Novartis. The CANOPY-A study evaluated adjuvant treatment for patients with stages II to IIIA and IIIB (T > 5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC).1
The experimental 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 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,” said Jeff Legos, executive vice president, global head of Oncology & Hematology Development at Novartis. “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.”
Investigators in this phase 3, multicenter, double-blind study randomized 1382 patients with NSCLC 1:1 to either 200 mg of subcutaneous canakinumab every 3 weeks or matching placebo for up to 1 year. Before randomization, these patients completed standard-of-care adjuvant cisplatin-based chemotherapy and radiation therapy, if applicable.
The primary end point of the study, which was not reached, was DFS, and the secondary end points included overall survival, DFS in PD-L1 subgroups, DFS in CD8 subgroups, lung-cancer-specific survival, and maximum observed plasma concentration of canakinumab.2
Patients were eligible if they have (R0) NSCLC stage II-IIIA and IIIB or have NSCLC stage II-IIIA, IIIB and are candidates for complete resection surgery. Further patient inclusion criteria include mandatory cisplatin-based chemotherapy, full 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 gross disease remaining at the time of surgery, have received any neoadjuvant therapy, have presence or history of a malignant disease, other than the resected NSCLC, that has been diagnosed and/or required therapy within the past 3 years, have a history of current diagnosis of cardiac disease, uncontrolled diabetes, known active or recurrent hepatic disorder. Further, subjects must be evaluated for tuberculosis, and those with active tuberculosis are not eligible.2
Canakinumab is a human monoclonal antibody which binds with high affinity and selectivity to human IL-1β and inhibits IL-1β activity.