Novartis developmental drug helps cut cardiovascular and cancer risks

BASEL, Switzerland — Novartis may have the next blockbuster drug in development, as recent research has found its anti-inflammatory prospect may lower the risk of both heart disease and cancer.



Novartis on Saturday 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.



“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,” stated Paul Ridker, CANTOS study chairman and director of the Center for Cardiovascular Disease Prevention at Brigham and Women’s Hospital.



“These data are a significant milestone because they show that selectively targeting inflammation with ACZ885 reduces cardiovascular risk and that ACZ885 may also be an important immuno-oncology therapy targeting IL-1β for lung cancer,” said Vas Narasimhan, global head, drug development and chief medical officer, Novartis. “We look forward to submitting the CANTOS data to regulatory authorities for approval in cardiovascular and initiating additional phase III studies in lung cancer.”



"We found that in high risk patients, a drug that lowers inflammation but has no effect on cholesterol reduced the risk of major adverse cardiovascular events," Ridker said. "In my lifetime, I've seen three broad eras of preventative cardiology. First we recognized the importance of diet, exercise and smoking cessation. Then we saw the tremendous value of lipid-lowering drugs such as statins. Now we're cracking the door open on the third era. This is very exciting."



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, a composite of non-fatal heart attack, non-fatal stroke and cardiovascular death, compared to placebo. 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 findings in cardiovascular risk reduction were presented Saturday at the European Society of Cardiology 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.



With more than 10,000 patients enrolled in the study over the last six years, CANTOS was one of the largest and longest-running clinical trials in Novartis' history. Additional positive benefit observed in the CANTOS study was a reduction in the number of patients requiring unplanned revascularization for worsening chest pains (unstable angina), a component of the four-point MACE key secondary endpoint.