Cankinumab (ACZ885) observed to reduce recurrent cardiovascular events.
Novartis recently announced positive results from the phase 3 CANTOS study, which explored the efficacy, safety, and tolerability of canakinumab (ACZ885) for the prevention of recurrent cardiovascular (CV) events.
Canakinumab is a selective, fully human monoclonal antibody that inhibits the inflammatory pathway, IL-1ß. The drug works by blocking the pathway and reducing inflammation resulting from overproduction, according to a press release.
Canakinumab is the first drug that has demonstrated the ability to selectively target inflammation and reduce the risk of recurrent CV events.
Included in the clinical trial were 10,061 patients who previously experienced a myocardial infarction (MI) and who have inflammatory atherosclerosis, according to a press release. Patients were treated with a quarterly injection of canakinumab or placebo in addition to standard care.
The primary endpoint of the trial was time to first major CV event, which included CV death, non-fatal MI, and non-fatal stroke.
Secondary endpoints included CV death, non-fatal MI, non-fatal stroke and hospitalization for unstable angina requiring unplanned revascularization; time to new onset of type 2 diabetes; time to occurrence of non-fatal MI, non-fatal stroke or all-cause mortality; and time to all-cause mortality, according to the release.
The investigators discovered that the study met the primary endpoint, suggesting that canakinumb plus standard care reduces the risk of recurrent heart attack among this population.
Even with current treatments, approximately 40% of patients who experience a heart attack remain at risk of experiencing a recurrent event due to inflammatory atherosclerosis, according to the release. With more than 750,000 patients in the United States experiencing a heart attack, it is clear that novel drug therapies are needed to reduce the risk of recurrent events.
Recurrent major adverse CV events among patients with inflammatory atherosclerosis increase the risk of morbidity, mortality, and reduced quality of life, Novartis reported. Additionally, this presents an economic burden to both patients and the healthcare system.
These results suggest that canakinumab may be used to reduce CV risks among these patients, according to the release.
Novartis plans to submit the full data to a future medical congress and for publication.
"Despite current treatment, about 25% of heart attack survivors will have another cardiovascular event within 5 years, making the outcome of the CANTOS study a promising new development for patients," said Vas Narasimhan, global head, Drug Development and Chief Medical Officer, Novartis. "ACZ885 is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk. Our priority now is to thoroughly analyze these important data and discuss them with regulatory agencies."