Results from the global phase III CANTOS study investigating the efficacy, safety and tolerability of Canakinumab ( ACZ885 ) in combination with standard of care in people with a prior myocardial infarction and inflammatory atherosclerosis, were announced .
With more than 10,000 patients enrolled in the study over the last six years.
The CANTOS study met the primary endpoint, demonstrating that when used in combination with standard of care, Canakinumab has reduced the risk of major adverse cardiovascular events ( MACE ), a composite of cardiovascular death, non-fatal myocardial infarction and non-fatal stroke, in patients with a prior myocardial infarction and inflammatory atherosclerosis.
Despite current treatment, about 25% of myocardial infarction survivors will have another cardiovascular event within five years, making the outcome of the CANTOS study a promising new development for patients.
Canakinumab is the first and only investigational agent which has shown that selectively targeting inflammation reduces cardiovascular risk.
Myocardial infarction occurs in about 580,000 people every year in European Union and 750,000 people in the United States alone.
In 2015 there were an estimated 7.29 million myocardial infarction globally.
Despite standard treatment, people with a prior heart attack live with a higher ongoing risk of having another event or dying, and it has been shown that in about four in 10 people, this risk is directly related to increased inflammation associated with atherosclerosis.
The recurrent MACE in patients with inflammatory atherosclerosis are associated with increased morbidity, mortality and reduced quality of life and currently represent a major economic burden on patients and healthcare systems around the world.
The Canakinumab Anti-inflammatory Thrombosis Outcomes Study ( CANTOS ) was a randomized, double-blind, placebo-controlled, event-driven phase III study designed to evaluate the efficacy, safety and tolerability of quarterly subcutaneous injections of Canakinumab in combination with standard of care in the prevention of recurrent cardiovascular events among 10,061 people with a prior myocardial infarction and with a high-sensitivity C-reactive protein ( hsCRP ) level of greater than or equal to 2mg/L.
The study has evaluated three different doses of Canakinumab vs placebo.
The primary endpoint of the study was time to first occurrence of major adverse cardiovascular event ( MACE ), a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke.
Secondary endpoints included time to first occurrence of the composite cardiovascular endpoint consisting of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina requiring unplanned revascularization; time to new onset type 2 diabetes among people with pre-diabetes at randomization; time to occurrence of non-fatal myocardial infarction, non-fatal stroke or all-cause mortality; and time to all-cause mortality.
The median follow-up time was 3.8 years. The study ran for approximately six years.
Canakinumab is a selective, high-affinity, fully human monoclonal antibody that inhibits IL-1beta, a key cytokine in the inflammatory pathway known to drive the continued progression of inflammatory atherosclerosis].
Canakinumab works by blocking the action of IL-1 beta for a sustained period of time, therefore inhibiting inflammation that is caused by its over-production.
Canakinumab is the first and only agent which has shown that selectively targeting inflammation significantly reduces cardiovascular risk in patients who have had a prior myocardial infarction and have an increased cardiovascular inflammatory burden. ( Xagena )
Source: Novartis, 2017