Phase III CANTOS study shows that canakinumab cuts CV risk by 15% and lung cancer mortality

Novartis on Sunday (August 27) revealed primary data from CANTOS, a Phase III study evaluating quarterly injections of ACZ885 (canakinumab) in people with a prior heart attack and inflammatory atherosclerosis as measured by high-sensitivity C-reactive protein (hsCRP) levels of >=2mg/L, a known marker of inflammation.

The study findings in cardiovascular risk reduction were presented at the European Society of Cardiology (ESC) Congress and published simultaneously in The New England Journal of Medicine. The details of the additional CANTOS lung cancer findings were also presented at ESC and simultaneously published in The Lancet.

Trial participants received either placebo or one of three doses of ACZ885 in combination with current standard of care therapies, with 91% of them taking lipid-lowering statins. The study showed that ACZ885 led to a statistically significant 15% reduction in the risk of major adverse cardiovascular events (MACE), a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo (p-value 0.021). This benefit was sustained throughout the duration of the study (median follow up 3.7 years) and was largely consistent across key pre-specified baseline sub groups. The study met the primary endpoint in cardiovascular risk reduction with the 150mg dose of ACZ885; the 300mg dose showed similar benefits and the 50mg dose was less efficacious.