Novartis targets specific patient population with strong Ilaris Phase 3 data

Novartis has presented new Phase 3 data on its cardiovascular drug Ilaris (canakinumab) which demonstrate particular efficacy in a specific subgroup of the trial’s patient population – a subgroup which the Swiss drugmaker is now looking to target with the drug.

Analysis of the Phase 3 data generated by the CANTOS trial showed that participants with a prior myocardial infarction who achieved high-sensitivity C-reactive protein (hsCRP) levels below 2mg/L at three months after the first dose of canakinumab saw a 25% reduction in major adverse cardiovascular events (MACE) compared to placebo. The group also saw a 31% reduction in cardiovascular death and all-cause death.

"This CANTOS analysis suggests that the initial biologic response to canakinumab may provide a simple method to identify which patients are most likely to obtain long-term benefits," explained Dr Paul Ridker, CANTOS Study Chairman and Director of the Center for Cardiovascular Disease Prevention at Brigham and Women's Hospital. "Importantly, these data also support the value of targeting inflammation when treating patients who have had a heart attack in the past, reinforcing that 'lower is better' when it comes to levels of inflammation."

According to Novartis, the subgroup in question accounted for 55% of the total patient pool for the six-year trial which comprised more than 100,000 heart attack survivors. The overall risk reduction offered by the drug for the total patient pool stands much lower at 15% - a figure which many consider inadequate to expand its existing approvals.

Perhaps as a result of these doubts, Novartis is now extolling the benefits of Ilaris as a targeted therapy. Vasant Narasimhan, Novartis’s Drug Development Chief who will take over as CEO in February, commented: "We are absolutely of the mind that we want this be a targeted medicine. If ... we would not have the opportunity to target this medicine, we would ultimately reconsider whether we would bring this medicine to market."

"This outcome is an exciting new development in the field of personalised cardiovascular medicine," he added. "In addition to offering targeted cardiovascular benefits for patients, personalised treatment approaches can also be more cost-efficient for the overall healthcare system. We hope we can bring this innovative treatment to patients in the near future."