Novartis CANTOS Study Meets Primary Endpoint In Cardiovascular Risk Reduction

(RTTNews) - Novartis (NVS) 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 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 Study showed a significant 15% reduction of major adverse cardiovascularevents (MACE) in people with a prior heart attack and inflammatory atherosclerosis who were treated with 150mg of ACZ885, in addition tostandard of care including lipid-lowering therapy.

Novartis plans to discuss the CANTOS study findings with health authorities and to submit the cardiovascular data for regulatory approval.

The company noted that a Sub-group of study participants whose inflammation was reduced below the median hsCRP saw a 27% relative risk reduction on primary MACE end-point

Additionally, a review of blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300mg of ACZ885.

The study findings in cardiovascular risk reduction were presented today at the European Society of Cardiology (ESC) 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.