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Merck & Co's anacetrapib data fails to generate much excitement

Treatment proves unable to reduce a composite outcome of major atherosclerotic events

Merck & CoMerck & Co's much anticipated REVEAL trial data has shown that anacetrapib cut major coronary events (MACE), but may not lead to regulatory filings for the CETP inhibitor.

Back in June, Merck announced that anacetrapib had achieved its primary endpoint in REVEAL, reducing MACE - a composite of coronary death, myocardial infarction and coronary revascularisation - compared with placebo in patients at risk for cardiac events already on statin therapy.

This week, Merck presented the results from the 30,000-patient trial in full at the European Society of Cardiology (ESC) meeting in Barcelona and simultaneously published its findings in the New England Journal of Medicine. However, anacetrapib's 9% reduction in MACE compared to placebo after four years, while statistically significant, may not be enough to persuade doctors to use the drug, according to analysts.

Moreover, Merck's drug also missed a key secondary objective, failing to reduce a composite outcome of major atherosclerotic events, which it said could have resulted from a lack of effect on ischaemic stroke. The company also said it had evidence that anacetrapib accumulates in fat tissue with prolonged dosing, which could raise safety issues.

Merck's chief medical officer Roy Baynes told the Goldman Sachs Healthcare Conference earlier this year that there will probably not be a market for the drug if the effect size is small, but a large effect could make the once-daily pill a viable proposition. What the threshold is for the latter remains uncertain for now, and the company said merely that it "is reviewing the results of the trial with external experts and will consider whether to file new drug applications".

While the company is debating whether to file for approval of anacetrapib, some analysts - including Bernstein's Tim Anderson - think that is now unlikely, not least because anacetrapib will have to contend in the statin add-on market with PCSK9 inhibitors such as Amgen's Repatha, which showed a larger (15%) risk reduction in the FOURIER trial but are still struggling to achieve take-up by physicians.

However, Umer Raffat of Evercore ISI thinks the company should press on as it has already invested heavily in the programme and has demonstrated a clinical benefit, and has had success selling Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin) in this therapeutic area despite a small effect on cardiovascular outcomes.

If Merck does choose to abandon anacetrapib the drug will follow several other failed CETP inhibitors, including Pfizer's torcetrapib, Roche's dalcetrapib and Eli Lilly's evacetrapib which all failed to show a benefit in reducing cardiovascular events when added to statins.

Article by
Phil Taylor

30th August 2017

From: Research

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