RAHWAY, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from three pivotal Phase 3 trials evaluating the investigational, once-daily, oral, two-drug regimen of doravirine/islatravir [DOR/ISL (100 mg/0.25 mg), (MK- 8591A)] in adults with HIV-1. The findings were shared in late-breaking presentations at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI) being held in Denver. "We are proud to contin ...

Core Insights - Merck announced positive top-line results from a pivotal late-stage study for its investigational HIV treatment DOR/ISL, demonstrating non-inferiority to Gilead's Biktarvy [1][4][6] Group 1: Study Results - The phase III MK-8591A-053 study evaluated DOR/ISL in treatment-naïve adults with HIV-1, showing comparable efficacy and safety to Gilead's Biktarvy [3][4] - The study met its primary endpoint, with a significant percentage of patients achieving HIV-1 RNA levels below 50 copies/mL at week 48 [4][8] - DOR/ISL's safety profile was found to be similar to that of Biktarvy, supporting its potential as a treatment option [4][8] Group 2: Regulatory and Market Implications - A regulatory filing for DOR/ISL to treat virologically suppressed adults on antiretroviral therapy is under FDA review, with a decision expected on April 28, 2026 [2] - Merck plans to present detailed results from the MK-8591A-053 study at a future medical conference and is preparing applications for approval to treat treatment-naïve HIV patients [5][6] - Year-to-date, Merck's shares have decreased by 4.4%, contrasting with the industry's growth of 14.5% [5] Group 3: Additional Developments - The European Commission approved the subcutaneous formulation of Keytruda, enhancing patient convenience and potentially increasing adoption rates [10][12] - The SC version of Keytruda can be administered in as little as one minute, compared to at least 30 minutes for the IV formulation, easing the burden on healthcare facilities [12][13]

Core Insights - Merck & Co. Inc. has reported positive topline results from a Phase 3 trial of the investigational drug regimen doravirine/islatravir (DOR/ISL) for treatment-naïve adults with HIV-1 infection [1][2] - The trial demonstrated that DOR/ISL met the primary efficacy criterion, showing non-inferiority to the existing treatment Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide) [2][5] - The safety profile of DOR/ISL was comparable to that of Biktarvy, fulfilling the primary safety objective of the trial [3][5] - The FDA has accepted the New Drug Application (NDA) for DOR/ISL, with a target action date set for April 28, 2026 [3] Efficacy and Safety - The primary efficacy success criterion was based on the percentage of participants achieving HIV-1 RNA levels below 50 copies/mL at Week 48 [2] - Both Phase 3 trials conducted in March showed that DOR/ISL met the primary efficacy and safety objectives at Week 48 [5] Regulatory Status - The FDA's acceptance of the NDA for DOR/ISL indicates a significant step towards potential market entry, aiming to replace current antiretroviral regimens for virologically-suppressed patients [3] Market Performance - Following the announcement, Merck's stock experienced a decline of 1.48%, trading at $95 [5]

Core Insights - The pharmaceutical industry is advancing innovative treatments for chronic disease management, with Merck & Co. Inc. announcing new data from Phase 3 studies on the two-drug regimen of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed HIV-1 infection [1] Group 1: Study Findings - The MK-8591A-052 trial showed that DOR/ISL maintained viral suppression and was non-inferior to the three-drug regimen BIC/FTC/TAF, with no treatment-emergent resistance observed [3] - In the MK-8591A-052 trial, participants switching to DOR/ISL experienced minimal weight changes at Week 48, with a mean weight change of -0.03 kg compared to +0.28 kg for BIC/FTC/TAF [4] - The percentage of participants experiencing significant weight gain (≥5% and ≥10%) was lower in the DOR/ISL group compared to the BIC/FTC/TAF group [4] Group 2: Body Composition and Lipid Changes - Changes in lean body mass, peripheral fat, trunk fat, body mass index, and waist-to-hip ratio were small and comparable between DOR/ISL and BIC/FTC/TAF treatment groups [5] - Minimal changes in fasting lipids were observed across both trials, with no substantial differences between DOR/ISL and comparator groups [6] - Less than 5% of participants with type 2 diabetes modified their medication across treatment groups, indicating stability in diabetic management [6] Group 3: Regulatory and Market Impact - The FDA has accepted the New Drug Application for DOR/ISL, with a target action date set for April 28, 2026 [7] - At the time of publication, Merck & Co shares were down 0.96% at $83.89 [7]

Core Insights - Merck announced new data from Phase 3 trials evaluating the investigational two-drug regimen of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed HIV-1 infection, showing minimal changes in weight and body composition, and no clinically meaningful effects on fasting lipids and insulin resistance [1][3][4] Group 1: Trial Results - In trial MK-8591A-052, adults switching to DOR/ISL from BIC/FTC/TAF exhibited minimal changes in weight at Week 48, with a mean weight change of -0.03 kg for DOR/ISL compared to +0.28 kg for BIC/FTC/TAF [5] - The percentage of participants experiencing a 5% weight gain was 14.6% for DOR/ISL and 16.0% for BIC/FTC/TAF, indicating comparable outcomes [5] - Both trials showed no clinically meaningful changes in fasting lipids or insulin resistance, with similar results across treatment groups [3][6] Group 2: Safety and Efficacy - Drug-related adverse events were similar between DOR/ISL and BIC/FTC/TAF, with 10.2% for DOR/ISL and 9.4% for BIC/FTC/TAF [10] - Rates of serious adverse events were also comparable, with 7.3% for DOR/ISL and 7.6% for BIC/FTC/TAF [10] - The trials reported no treatment-emergent resistance to DOR or ISL, reinforcing the safety profile of the investigational regimen [1][4] Group 3: Regulatory Status - The FDA accepted the New Drug Application (NDA) for DOR/ISL, with a target action date set for April 28, 2026 [7] Group 4: Demographics and Study Design - The MK-8591A-052 trial included 513 adults with a median age of 47 years, with 21.4% assigned female sex at birth and 30.8% identifying as Black or African American [8] - The MK-8591A-051 trial involved 551 adults, with a median age of 51 years, and a similar demographic distribution [11][12]

Core Insights - Merck (MRK) has received FDA acceptance for the new drug application (NDA) for its investigational two-drug regimen doravirine/islatravir (DOR/ISL) aimed at treating virologically suppressed adults with HIV-1 infection, with a decision expected by April 28, 2026 [1][7] Drug Efficacy and Studies - If approved, DOR/ISL would be the first non-integrase inhibitor-based two-drug regimen demonstrating comparable efficacy and safety to the current three-drug standard, BIC/FTC/TAF, in phase III studies [2] - The NDA is supported by data from two pivotal phase III studies (MK-8591A-051 and MK-8591A-052), which showed that DOR/ISL (100 mg/0.25 mg) was non-inferior to comparator antiretroviral therapies in adults with virologically suppressed HIV-1 [3] Ongoing Research and Collaborations - Merck is continuing its HIV research with additional trials, including MK-8591A-053 and MK-8591A-054, which evaluate DOR/ISL in treatment-naïve individuals and those from earlier studies, respectively [9][10] - The company is collaborating with Gilead Sciences (GILD) to evaluate islatravir in combination with GILD's lenacapavir in a phase II study for HIV treatment [10] Stock Performance - Year to date, Merck's shares have decreased by 15.5%, contrasting with a 0.2% rise in the industry [4]