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Canakinumab trial data in non-small cell lung cancer released

Canakinumab adjuvant treatment in adults with non-small cell lung cancer failed to improve disease-free survival compared to placebo.

Results from the Novartis 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 cancer cases globally in 2020 and 1.80 million deaths. Moreover, between 80 and 85% of all lung cancers are due to NSCLC and though surgery is the only potentially curative treatment 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, which looked at the role of canakinumab in preventing further myocardial infarction, stroke, or cardiovascular death in patients with elevated C‐reactive protein.

While CANTOS found that 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. Moreover, it has been suggested that IL-1β inhibition might represent an effective anti-tumour therapy. Novartis therefore considered that their monoclonal antibody could have a role in 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, 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.‘

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