An exploratory pre-specified analysis of the PIII CANTOS study (NCT01327846) suggests that canakinumab has a dose-dependent reduction in hospitalisation for HF (HHF) and composite of HHF/HF-related mortality, versus placebo in 10,061 patients with prior MI and elevations in CRP .
Two new analyses of data from more the CANTOS study were presented at the 2018 American College of Cardiology meeting. Investigators found that canakinumab substantially reduced cardiovascular event rates in high-risk atherosclerotic patients with chronic kidney disease (CKD) or those with pre-diabetes/diagnosed type 2 diabetes. In chronic kidney disease patients, the drug reduced the risk of MACE by 18% over placebo. For patients with diabetes, the reduction was 10%, while those with prediabetes experienced a 14% risk reduction. The drug didn´t prevent prediabetes patients from progressing to diabetes. Results from diabetes patients have been published in the Journal of the American College of Cardiology .
Novartis announced results of a pre-planned secondary analysis of results of an exploratory endpoint of the PIII CANTOS trial showing that a subgroup of post MI patients (about 55% of the trial subjects) who achieved hsCRP levels <2mg/L at three months after receiving the first dose of canakinumab had a 25% reduction in MACE vs. placebo (p<0.0001). These patients also had a significant reduction of 31% in the rate of CV death (p=0.0004) and all-cause death (p<0.0001). There was no significant reduction in these endpoints observed among those treated with canakinumab who achieved hsCRP levels 2mg/L or more, suggesting that on-treatment hsCRP testing may offer a way of indentifying the patients most likely to achieve the greatest benefits from canakinumab treatment. These results have been published in the Lancet .
Data from the CANTOS study presented at the European Society of Cardiology (ESC) Congress. The study showed a significant 15% reduction of major adverse cardiovascular events (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg canakizumab in addition to standard of care (p=0.021). Results have been published in the NEJM. Secondary results indicate that canakinumab may reduce the risk of lung cancer. This was added as a secondary outcome as a lead researcher was aware that the pathway that canakinumab acts on is also important in cancer. The study results showed a significant and dose-related reduction in lung cancer risk in patients receiving canakinumab vs placebo: as a result, Novartis plans to initiate a PIII trial specifically examining the drug´s potential in this indication [8,9].
Novartis announces topline results for CANTOS - when added to standard care, canakinumab met its primary outcome, reducing risk of major adverse cardiovascular events (MACE). Full results will be presented and published during 2017 .
The PIII CANTOS study (NCT01776424) is ongoing, but no longer recruiting participants, with an estimated final data collection date for the primary outcome measure of Feb 2017 .
NCT01327846 is a randomized, double-blind, placebo-controlled, event driven PIII trial of quarterly subcutaneous canakinumab in the prevention of recurrent cardiovascular events among 7302 stable post-myocardial infarction patients with elevated hsCRP. The primary outcome is time to first occurrence of a major adverse cardiovascular event (composite of CV death, non-fatal MI and stroke). The study started in Apr 11 and is due to complete Dec 16 .