Merck’s anacetrapib trial design could become standard for future CETP inhibitor trials in hypercholesterolemia; PCSK9 data potential success bar– experts

14 Jul 2017

Merck’s (NYSE:MRK) Phase III anacetrapib REVEAL results have triggered expert discussion about potential optimal future CETP inhibitor hypercholesterolemia trial design options in order to be competitive with PCSK9 inhibitors. They noted CETP inhibitors needed to match the 14% benefit seen for PCSK9 inhibitors, whilst noting that similar patient numbers and trial length to REVEAL would likely be required and ideal LDL levels should fall between 61 and 100 in the inclusion criteria. 

Analysts have noted that if approved the CETP inhibitor anacetrapib could be a cheaper alternative to PCSK9 inhibitors such as Amgen’s (NASDAQ:AMGN) Repatha (evolocumab) and Sanofi (EPA:SAN)/Regeneron Pharmaceuticals’ (NASDAQ:REGN) Praluent (alirocumab). Amgen's CETP inhibitor AMG899 has yet to enter Phase III as it is awaiting the results of competitor trials, according to one analyst report.

Although anacetrapib monotherapy could be considered if statin therapy is not enough to bring LDL levels under control, it is unlikely to be a blockbuster market strategy considering cheap statins is the standard in LDL-lowering regimens, some experts said. Four-year trials with large patient populations similar to that of the REVEAL (NCT01252953) trial would be optimal, experts noted. Perhaps anacetrapib and other CETP inhibitors could find a niche subpopulation via genetic analysis where it could display clinically relevant benefit, two experts added.

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