Novartis has reported 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 that involved 10,000 patients, 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, the company said. 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.
“The results of CANTOS are exciting because we now have clear evidence that in addition to lowering cholesterol, targeting inflammation reduces patients’ risk of cardiovascular disease, and perhaps even lung cancer,” said Dr. Paul Ridker, MD, CANTOS Study Chairman and Director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital.
Novartis said that CANTOS was one of the largest and longest-running clinical trials in Novartis’ history.