Edward B. Garon, MD, MS, provides an overview of the phase 3 CANOPY-A study.
Edward B. Garon, MD, MS, professor of medicine, Geffen School of Medicine, Department of Medicine, Division of Hematology/Oncology, University of California, Los Angeles, provides an overview of the phase 3 CANOPY-A study (NCT03447769).
In the phase 3, multicenter, double-blind study, investigators examined adjuvant canakinumab (Ilaris) in patients with completely resected non-small cell lung cancer (NSCLC). The primary end point of the study was disease-free survival (DFS) and the secondary end points were overall survival, DFS in PD-L1 subgroups, DFS in CD8 subgroups, lung-cancer-specific survival, and maximum observed plasma concentration of canakinumab.
According to Garon, results from 1382 patients with NSCLC were overall negative as canakinumab failed to meet its primary end point of DFS.
0:08 | The CANOPY-A study was designed as a 1500 patient study to evaluate the potential for canakinumab in patients with completely resected non–small cell lung cancer. The design was a 1:1 randomization between canakinumab every 3 weeks, continuously, vs placebo. The primary end point of the study was disease-free survival, and key secondary end point was overall survival to be tested only if disease-free survival was positive.
0:43 | Unfortunately, the primary end point which was disease-free survival was not positive. Although numerically it did favor canakinumab, particularly at the median, the one-sided P value was 0.26, reflecting the similarity of the curves throughout the entirety of the curve, with a hazard ratio that was not particularly impressive. In addition, when looking for different subgroups, we were not able to find subgroups where the 95% confidence interval excluded 1. As a result, this is a study that was not able to show the value of canakinumab in the setting of completely resected non–small cell lung cancer.