Type: Monoclonal antibody designed to bind to and neutralize interleukin-1 beta (IL-1β)
Status: Novartis acknowledged on November 6 that canakinumab failed the Phase III CAN-COVID trial (NCT04362813) designed to assess the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS). Canakinumab plus standard of care (SoC) failed to meet the trial’s primary endpoint of significantly greater chance of survival for patients without the need for invasive mechanical ventilation up to Day 29, compared with placebo plus SoC. CAN-COVID also failed to meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment, Novartis said.
In the randomized, double-blind, placebo-controlled trial, the primary endpoint of survival without the need for mechanical ventilation was 88.8% for canakinumab plus SoC vs 85.7% for placebo plus SoC. The key secondary endpoint of COVID-19-related mortality up to 4 weeks was 4.9% for canakinumab plus SoC vs 7.2% for placebo plus SoC. While both the primary and key secondary endpoints trended in favor of canakinumab, they did not reach statistical significance, Novartis said. The trial enrolled 454 patients at multiple centers across the U.S., Russia, and Europe.
Data from CAN-COVID will be submitted to a peer-reviewed journal “in the coming weeks,” Novartis added. Results from CAN-COVID will not affect other ongoing trials for canakinumab, including studies for the treatment of non-small cell lung cancer (NSCLC). Canakinumab is now marketed under the name Ilaris® for two forms of arthritis: Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older, for which the drug won FDA approval in 2013; and Active Still’s disease, including Adult-Onset Still’s Disease (AOSD), the latter following FDA approval in June 2020.
Canakinumab is one of three COVID-19 candidates under study by Novartis. The others are ruxolitinib, marketed as Jakavi® by Novartis and Jakafi® by Incyte; and MP0420 and MP0423, two DARPin® therapies being developed by Novartis in collaboration with Switzerland-based Molecular Partners.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data.
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: