Setback for Novartis drug in advanced lung cancer trial

By Jane Byrne contact

- Last updated on GMT

© GettyImages/Mohammed Haneefa Nizamudeen
© GettyImages/Mohammed Haneefa Nizamudeen

Related tags: Lung cancer, Novartis

Novartis reported today that a clinical trial of the drug, known as canakinumab, when combined with chemotherapy agent, docetaxel, failed to extend the lives of patients with advanced or metastatic non-small cell lung cancer compared to just chemotherapy alone.

Canakinumab, branded as Ilaris, blocks a molecule that stimulates inflammation - interleukin-beta.

The trial was conducted among 237 adults whose disease progressed while on or after previous platinum-based chemotherapy and PD-(L)1 inhibitor immunotherapy.

“While results from the Canopy-2 trial are not what we hoped for in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have been treated with other lines of therapy, these data give us valuable insights into IL-1β inhibition​,” said Dr John Tsai, head of global drug development and chief medical officer at Novartis.

Adults with NSCLC are challenging to treat. Tsai said Novartis is conducting studies in earlier stages of the disease, including a Phase III trial testing the interleukin-1β inhibitor in newly-diagnosed patients and a Phase III trial evaluating the drug as an adjuvant to prevent recurrence.

Lung cancer is the most common cancer worldwide, accounting for more than 2 million new cases diagnosed each year, as per WHO data. NSCLC accounts for approximately 85% of lung cancer diagnoses, resulting in nearly 1.7 million new cases each year, found a review​ on cancer statistics. 

Novartis claims that preliminary data suggested that canakinumab, enhances anti-tumor immune response and reduces tumor cell proliferation, survival, and invasiveness.

Eureka moment 

The Swiss multinational launched the Canopy study program after observing significantly lower than expected rates of lung cancer mortality among patients in the Phase III cardiovascular Cantos trial, which evaluated canakinumab as a secondary prevention measure for cardiovascular events in patients following a heart attack.

Patients in the Cantos trial were also at high risk for inflammatory cancers, like lung cancer, due to advanced age, smoking history, and other clinical risk factors. Based on these findings, Novartis launched three, large-scale, randomized, Phase III clinical trials and a Phase II clinical trial to investigate canakinumab as a potential treatment option in non-small cell lung cancer (NSCLC).

Rare disease work 

Canakinumab is also used in the treatment of rare inflammatory disorders, with sales of the drug in that domain last year showing a 31% increase on sales in 2019.

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