Novartis provides update on CAN - COVID trial of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome.

Novartis announced new data from an interim analysis for the randomized, double-blind, placebo-controlled CAN-COVID trial evaluating the efficacy and safety of canakinumab in hospitalized patients with COVID-19 pneumonia and cytokine release syndrome (CRS). The ongoing trial failed to meet its primary endpoint showing that treatment with canakinumab plus standard of care (SoC) did not demonstrate a significantly greater chance of survival for patients without the need for invasive mechanical ventilation, compared with placebo plus SoC up to Day 291 . The trial did not meet its key secondary endpoint of reducing the COVID-19-related death rate during the 4-week period after treatment1. The safety profiles of canakinumab plus SoC and placebo plus SoC were comparable. In the 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 (P=0.29). 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 (P=0.33). Both the primary and key secondary endpoints trended in favor of canakinumab but did not reach statistical significance. No new safety signals for canakinumab were identified. This interim analysis will be submitted to a peer-reviewed journal in the coming weeks.The CAN-COVID results do not affect any other ongoing trials for canakinumab, including investigations for the treatment of non-small cell lung cancer (NSCLC).