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Results of CANOPY-A trial of canakinumab in non-small cell lung cancer released

18th August 2022

Results show that adjuvant treatment with canakinumab in adults with non-small cell lung cancer failed to meet the primary endpoint of disease-free survival compared with placebo

According to a press release by Novartis, results from their CANOPY-A trial show that canakinumab failed to meet the primary endpoint of disease-free survival in adult patients with stages II-IIIA and IIIB (T>5cm N2) completely resected (R0) non-small cell lung cancer (NSCLC).

Lung cancer was responsible for approximately 2.21 million cases globally in 2020 and 1.80 million deaths. Moreover, between 80 and 85% of all lung cancers are due to NSCLC and while surgery remains the only potentially curative modality for early-stage NSCLC, 30% to 55% of patients develop recurrence and die of their disease despite curative resection.

CANOPY-A was a randomised, double blind, placebo-controlled study designed to evaluate the efficacy and safety of canakinumab compared with placebo as an adjuvant therapy in NSCLC. The rational for CANOPY-A arose after a finding from data obtained in the CANTOS trial, designed to examine the role of canakinumab in preventing further myocardial infarction, stroke, or cardiovascular death in patients with elevated C‐reactive protein. While CANTOS observed how anti-inflammatory therapy targeting the interleukin-1β innate immunity pathway, led to a significantly lower rate of recurrent cardiovascular events than placebo, the authors also noted a dramatic reduction in the number of incident cases of lung cancer.

Canakinumab is a human immunoglobulin monoclonal antibody with a high affinity and specificity for IL-1β, blocking its interaction with the IL-1 receptor. Furthermore, it has been suggested that IL-1β inhibition might represent an effective anti-tumour therapy. Therefore, Novartis considered that there was a potentially sound rational to examine the role of their monoclonal antibody as a cancer therapy.

In the CANOPY-A trial, 1382 patients were randomised 1:1 to either canakinumab, 200 mg subcutaneously every three weeks, or matching placebo for up to one year and all patients received cisplatin-based chemotherapy before randomisation. The primary outcome for the study was disease free survival (DFS) and although the press release does not contain any further details, canakinumab was not superior to placebo and the results will be presented at a future medical meeting.

Commenting on these findings in the press release, Jeff Legos, Executive Vice President, Global Head of Oncology & Haematology Development, Novartis, said ‘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.’