Merck's investigational once-daily Isentress meets Phase III goals
US pharma giant Merck & Co (NYSE: MRK) has released positive top-line results from the company’s Phase III pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of Isentress (raltegravir) for previously untreated HIV-1 infected adults.
The study met its primary efficacy endpoint: 1200mg raltegravir (given as 2 x 600mg once-daily) was statistically non-inferior to the marketed formulation approved dose of Isentress 400mg twice-daily, each in combination therapy with Truvada (emtricitabine and tenofovir disoproxil fumarate), as assessed by the proportion of patients achieving HIV-1 RNA <40 copies/mL at Week 48. In addition, the secondary endpoints of tolerability and immunologic efficacy (as measured by change from baseline in CD4 cell counts at Week 48) were comparable.
Plans to file with FDA and EMA
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