Photo Credit: Svitlana Hulko

The following is a summary of “Canakinumab as Adjuvant Therapy in Patients With Completely Resected Non–Small-Cell Lung Cancer: Results From the CANOPY-A Double-Blind, Randomized Clinical Trial,” published in the October 2023 issue of Oncology by Garon, et al.

For a study, researchers sought to evaluate the efficacy of canakinumab, an inhibitor of the interleukin (IL)-1β pathway, in treating resectable non–small-cell lung cancer (NSCLC). Given the high relapse rates and limited effective treatments available for this type of cancer, understanding potential therapeutic avenues like the IL-1β pathway becomes crucial.

The CANOPY-A study was designed as a phase III, randomized, double-blind, multicenter trial. The study involved adult patients diagnosed with stage II-IIIA or IIIB (T >5 cm, N2-positives II-IIIB; as per the American Joint Committee on Cancer/Union for International Cancer Control version 8 criteria) NSCLC. These patients had previously undergone complete resection and had received adjuvant cisplatin-based chemotherapy. The primary objective was to determine disease-free survival (DFS), while overall survival (OS) served as a key secondary endpoint.

The study included 1,382 patients, with 693 in the canakinumab group and 689 in the placebo group. Throughout the 18 cycles administered every three weeks, adverse events (AEs) of grade ≥3 were observed in 20.8% of the canakinumab group and 19.6% of the placebo group. Similarly, AEs led to treatment discontinuation in 4.3% and 4.1% of patients in the respective groups. Disappointingly, the study did not achieve its primary objective of demonstrating a significant difference in DFS between the two groups. The median DFS was 35.0 months in the canakinumab group and 29.7 months in the placebo group, with a hazard ratio of 0.94 (95% CI, 0.78 to 1.14; one-sided P = .258). Subgroup analyses of DFS did not reveal any meaningful distinctions between the two arms. Although canakinumab effectively reduced C-reactive protein and IL-6 levels due to its IL-1β pathway inhibition, these biomarker reductions did not correlate with improved clinical outcomes. The OS was not formally analyzed, given the lack of statistical significance in DFS outcomes.

The CANOPY-A trial did not demonstrate any disease-free survival benefits of incorporating canakinumab post-surgery and following adjuvant cisplatin-based chemotherapy in patients with resected stage II-III NSCLC. Despite not meeting its primary endpoint, the study did not identify any new safety concerns associated with the use of canakinumab.

Source: ascopubs.org/doi/10.1200/JCO.23.00910