Merck & Co., Inc. - MRK STOCK NEWS

Merck (MRK) announced positive topline results from two pivotal Phase 3 trials evaluating its investigational once-daily, oral, two-drug, single-tablet regimen of doravirine/islatravir (DOR/ISL) for treating adults with virologically suppressed HIV-1 infection. The trials met their primary efficacy endpoints, demonstrating non-inferiority to baseline antiretroviral therapy and bictegravir/emtricitabine/tenofovir alafenamide.

The DOR/ISL (100 mg/0.25 mg) combination showed comparable safety profiles to other therapies in both trials. While superiority criteria were not met in trial MK-8591A-052, the company plans to present detailed findings at a future scientific congress and submit data to regulatory authorities.

Merck (NYSE: MRK) has entered into an exclusive global license agreement with Hansoh Pharma for HS-10535, an investigational preclinical oral small molecule GLP-1 receptor agonist. Under the agreement, Merck will pay $112 million upfront and up to $1.9 billion in potential milestone payments, plus royalties on sales. Hansoh retains rights to co-promote or solely commercialize the drug in China under certain conditions.

The deal will result in a pre-tax charge of $112 million ($0.04 per share) in Merck's Q4 2024 GAAP and non-GAAP results. The partnership aims to leverage Merck's experience in incretin biology to evaluate HS-10535's potential for cardiometabolic benefits beyond weight reduction.

Merck (MRK) announced FDA acceptance of its Biologics License Application (BLA) for clesrovimab, a long-acting monoclonal antibody designed to protect infants from RSV disease. The FDA set a target action date of June 10, 2025.

The application is supported by results from the Phase 2b/3 CLEVER trial and interim results from the ongoing Phase 3 SMART trial, which evaluated clesrovimab's safety and efficacy in healthy preterm and full-term infants. If approved, clesrovimab would be the first and only single dose immunization for infants regardless of weight, protecting them throughout their first RSV season.

Merck anticipates making clesrovimab available for ordering by July 2025, in time for the 2025-26 RSV season.

Merck (MRK) announced the discontinuation of clinical development programs for two investigational drugs: vibostolimab (anti-TIGIT antibody) and favezelimab (anti-LAG-3 antibody), both being tested in combination with pembrolizumab. The decision follows the failure of Phase 3 KeyVibe-003 and KeyVibe-007 trials in non-small cell lung cancer patients, which met pre-specified futility criteria for overall survival.

The company is also terminating the Phase 3 KEYFORM-008 trial for favezelimab in classical Hodgkin lymphoma patients. While no new safety concerns were identified, the fixed-dose combinations showed more immune-related adverse events than pembrolizumab alone. Merck will prioritize other candidates in its oncology pipeline, with ongoing data analyses to be shared with the scientific community.

Merck's KEYTRUDA has received approval from China's NMPA for use in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by monotherapy after surgery for patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). This marks KEYTRUDA's fourth NSCLC indication in China and first for earlier stages.

The approval is based on the KEYNOTE-671 trial results, which showed significant improvements in overall survival, reducing death risk by 28% compared to placebo plus chemotherapy. The KEYTRUDA-based regimen also improved event-free survival, reducing the risk of disease recurrence, progression, or death by 42%. The treatment's adverse reactions were consistent with its known safety profile across tumor types.

Merck (MRK) received a positive CHMP opinion recommending conditional approval of WELIREG® (belzutifan) in the European Union for two indications: treatment of adult patients with von Hippel-Lindau (VHL) disease-associated tumors and advanced renal cell carcinoma (RCC). The recommendation is based on the LITESPARK-004 and LITESPARK-005 trials.

In LITESPARK-004, WELIREG showed significant efficacy with 49% objective response rate in VHL-associated RCC, 63% in CNS hemangioblastomas, and 83% in pancreatic neuroendocrine tumors. In LITESPARK-005, WELIREG reduced disease progression or death risk by 25% versus everolimus. A final EU decision is expected in Q1 2025.

LYNPARZA demonstrated significant long-term survival benefits in the OlympiA Phase 3 trial for early breast cancer patients. At 6.1 years median follow-up, the drug reduced death risk by 28% compared to placebo, with 87.5% of treated patients surviving versus 83.2% in the placebo group.

The trial showed LYNPARZA reduced the risk of invasive breast cancer recurrence, second cancers or death by 35%, and similarly reduced the risk of distant disease recurrence. The drug maintained its established safety profile with no new safety signals identified during the extended follow-up period.

LYNPARZA is currently approved in multiple countries for treating germline BRCA-mutated, HER2-negative high-risk early breast cancer, based on these OlympiA trial results.

Merck (MRK) announced positive results from its Phase 3 KEYLYNK-001 trial, evaluating KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for BRCA non-mutated advanced epithelial ovarian cancer. The trial met its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to chemotherapy alone.

However, the study did not reach its secondary endpoint of overall survival (OS), and the role of KEYTRUDA in the intention-to-treat population remains uncertain. The safety profiles were consistent with previously reported studies. Results will be presented at an upcoming medical meeting and discussed with regulatory authorities.

Merck (MRK) announced promising results from its Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin combined with R-CHP for treating previously untreated diffuse large B-cell lymphoma (DLBCL). The trial achieved a 100% complete response rate in patients treated with the 1.75 mg/kg dose, which has been established as the recommended Phase 3 dose.

The study enrolled 36 patients across three dosage groups (1.75, 2.0, and 2.25 mg/kg). The total complete response rate was 97.2%, with a median follow-up of 17.6 months. The 12-month duration of response was 93.5%. Serious treatment-related adverse events occurred in 11% of patients, with Grade 3-4 adverse events reported in 58% of patients, primarily including neutropenia, nausea, anemia, and diarrhea.