Preliminary results from two Phase 3 trials for a combination tablet containing Merck's (MRK.US) drug islatravir and Gilead Sciences' (GILD.US) drug lenacapavir have successfully met their primary endpoints, according to the companies.
The ISLEND-1 and ISLEND-2 studies are evaluating a once-weekly treatment regimen in virologically suppressed people with HIV who were previously on Biktarvy (bictegravir/emtricitabine/tenofovir) (ISLEND-1) or a standard oral antiretroviral therapy regimen (ISLEND-2).
The primary endpoint for both trials was the number of participants with HIV-1 RNA ≥ 50 copies/mL at week 48. The research also found that the islatravir/lenacapavir combination was non-inferior to Biktarvy and the standard oral antiretroviral therapy.
Islatravir is a nucleoside reverse transcriptase translocation inhibitor, which Merck sells in a fixed-dose combination with doravirine under the brand name Idvynso. Lenacapavir is marketed by Gilead Sciences under the brand name Sunlenca.
Separately, the two companies announced that, based on a recommendation from the Data Monitoring Committee, they are discontinuing the Phase 3 KEYNOTE-D46/EVOKE-03 study evaluating Gilead's Trodelvy in combination with Merck's Keytruda as a first-line treatment for metastatic non-small cell lung cancer.
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