Early data show Novartis' Ilaris fails to cut mortality in COVID-19 study

Novartis reported Friday that a Phase III study evaluating Ilaris (canakinumab) as a potential treatment of cytokine release syndrome (CRS) in patients with COVID-19-induced pneumonia missed its main goal, failing to show significantly improved odds of survival without the need for intubation. The interim analysis of the CAN-COVID trial also indicated that the monoclonal antibody targeted at IL-1 beta was not significantly better than standard care at reducing the rate of COVID-19 mortality, a key secondary endpoint.

The study included 454 hospitalised COVID-19 patients with pneumonia and CRS who were randomised to receive Ilaris or placebo, on top of standard of care. Patients were hypoxic, but did not require invasive mechanical ventilation. Participants ranged in age from 18 to 98 years old, with 58 being the average, and were recruited at various sites in the US, Europe and Russia. The primary endpoint was the number of patients demonstrating a clinical response, defined as survival without ever requiring invasive mechanical ventilation from days three to 29, while a key secondary goal was COVID-19-related death rate during the four-week period after study treatment.

According to Novartis, the data show that 88.8% of patients in the Ilaris group survived without having to undergo mechanical ventilation, compared to 85.7% for placebo. The COVID-19-related death rates between the two groups were 4.9% and 7.2%, respectively. Novartis noted that while both the primary and key secondary endpoints trended in favour of Ilaris, neither reached statistical significance. The safety profiles of both treatment groups were comparable.

Full data due early next year

The company plans to submit the interim analysis to a peer-reviewed journal in the coming weeks. Meanwhile, the study is ongoing and will continue to day 127, with full results expected in early 2021. Novartis' chief medical officer John Tsai remarked that while "the CAN-COVID trial did not show the patient benefit we were hoping for, it helps improve the scientific understanding of COVID-19 and the role of IL-1-beta inhibition."

Novartis noted that the CAN-COVID results do not affect any other ongoing trials for Ilaris, including investigations for the treatment of non-small-cell lung cancer. The drug is approved in approximately 60 countries, including the US, Europe and others, to treat multiple auto-inflammatory diseases such as periodic fever syndromes, adult-onset Still's disease (AOSD) and systemic juvenile idiopathic arthritis.

The drugmaker has another late-stage trial of its JAK inhibitor Jakavi (ruxolitinib) against COVID-19 under way, and recently teamed up with Molecular Partners to develop DARPin therapeutics for the coronavirus, with Phase I trials of the antiviral candidate MP0420 expected to begin this month.

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