Zinger Key Points
- Merck's DOR/ISL regimen demonstrated non-inferiority to bART and BIC/FTC/TAF in two pivotal Phase 3 trials for adults with HIV-1.
- Both trials achieved primary safety objectives, with detailed results to be presented at a future scientific congress.
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On Thursday, Merck & Co Inc MRK revealed topline results from two pivotal Phase 3 trials of a two-drug regimen of doravirine/islatravir (DOR/ISL) in adults with HIV-1 infection.
The trials included patients who were virologically suppressed on different antiretroviral therapy regimens, including antiretroviral therapy regimens [baseline antiretroviral therapy (bART) and Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF).
DOR/ISL was demonstrated to be non-inferior to bART in open-label trial MK-8591A-051 and non-inferior to BIC/FTC/TAF in double-blind trial MK-8591A-052.
Trial MK-8591A-052 did not meet the superiority criteria, but both trials also met the primary safety objectives.
The company plans to present detailed findings from these trials at a future scientific congress and file the data with regulatory authorities.
In the U.S., doravirine is approved for the treatment of adults with HIV-1 in combination with other antiretrovirals, as a single agent (PIFELTRO) and a component of a single-tablet regimen [DELSTRIGO; doravirine, lamivudine, and tenofovir disoproxil fumarate (DOR/3TC/TDF)].
Islatravir (MK-8591), Merck’s investigational drug, is being evaluated in multiple early and late-stage clinical trials in combination with other antiretroviral therapies for the treatment of HIV-1.
In addition to the MK-8591A-051 and MK-8591A-052 trials, ongoing Phase 3 trials of DOR/ISL include MK-8591A-053 in people with HIV who had not previously received treatment (treatment-naïve) and MK-8591A-054 evaluating open-label DOR/ISL in individuals who participated in earlier Phase 3 trials of DOR/ISL.
Price Action: MRK stock is up 1.18% at $99.50 at last check Thursday.
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