Merck & Co Stock Price, News & Analysis

Moderna and Merck have reported three-year data from their Phase 2b study showing that the combination of mRNA-4157 (V940) and KEYTRUDA significantly improves recurrence-free survival (RFS) and distant metastasis-free survival (DMFS) in patients with high-risk stage III/IV melanoma. The combination therapy reduced the risk of recurrence or death by 49% and distant metastasis or death by 62% compared to KEYTRUDA alone. The 2.5-year RFS rate for the combination was 74.8% versus 55.6% for KEYTRUDA alone.

The companies have started Phase 3 trials for melanoma and non-small cell lung cancer, and Phase 2 trials for renal and urothelial carcinomas, and a Phase 2/3 trial for cutaneous squamous cell carcinoma. Safety profiles were consistent with previous findings, showing mostly mild to moderate side effects.

Merck (NYSE: MRK) has announced that the FDA has accepted their supplemental Biologics License Application (sBLA) for priority review. The application seeks approval for the use of KEYTRUDA® (pembrolizumab) combined with chemotherapy as a first-line treatment for patients with unresectable advanced or metastatic malignant pleural mesothelioma (MPM).

The acceptance is based on data from the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed a statistically significant improvement in overall survival (OS) when compared to chemotherapy alone. The target action date set by the FDA is September 25, 2024. In the trial, KEYTRUDA combined with chemotherapy reduced the risk of death by 21%, with a median OS of 17.3 months versus 16.1 months for chemotherapy alone. Additionally, the combination treatment showed improvements in progression-free survival (PFS) and objective response rate (ORR).

Merck (NYSE: MRK) has announced its acquisition of EyeBio for an upfront payment of $1.3 billion and up to $1.7 billion in milestone payments, bringing the total potential value to $3 billion. EyeBio's lead candidate, Restoret™, is a late-phase treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (NVAMD). Restoret is expected to enter pivotal studies in the second half of 2024. The acquisition expands Merck's presence in ophthalmology and aims to leverage EyeBio's expertise in retinal diseases. The transaction, subject to regulatory approval, is anticipated to close in Q3 2024, and Merck expects to record a charge of $1.3 billion upon closing.

Merck (NYSE: MRK), referred to as MSD outside of the US and Canada, has announced a quarterly dividend of $0.77 per share for the third quarter of 2024. The dividend will be paid on July 8, 2024, to shareholders who are registered by the close of business on June 17, 2024.

Merck (NYSE: MRK) announced that its Phase 3 KEYNOTE-522 trial met its overall survival (OS) endpoint for patients with high-risk early-stage triple-negative breast cancer (TNBC) using KEYTRUDA (pembrolizumab). The regimen, combining pre-operative chemotherapy with subsequent monotherapy, showed a statistically significant improvement in OS. The safety profile was consistent with previous studies, with no new safety signals. KEYTRUDA is now the first immunotherapy-based treatment to provide a survival benefit over chemotherapy alone in this patient group. These results, building on previous positive outcomes, will be presented at a medical meeting and shared with regulatory authorities.

Merck (NYSE: MRK) will present new data on its oncology treatments at the 2024 ASCO Annual Meeting from May 31-June 4. Highlights include Phase 3 results for sacituzumab tirumotecan in metastatic triple-negative breast cancer and three-year follow-up data for mRNA-4157 (V940) combined with KEYTRUDA in high-risk melanoma patients. Other key data involve updated findings for KEYTRUDA in various cancers, including advanced gastrointestinal cancers and metastatic bladder cancer. Merck's diverse oncology pipeline will also be showcased, featuring investigational treatments such as vibostolimab/pembrolizumab and sacituzumab tirumotecan. The company will hold an Oncology Investor Event on June 3, 2024, to discuss these developments.

Merck (MRK) announced the discontinuation of the vibostolimab and pembrolizumab coformulation arm of the Phase 3 KeyVibe-010 trial for adjuvant treatment of resected high-risk melanoma due to primary endpoint not met. Patients in the coformulation arm had higher discontinuation rates mainly due to immune-mediated adverse experiences. The study is being unblinded, and patients are recommended to switch to KEYTRUDA monotherapy. Merck remains committed to developing new melanoma treatments and is exploring other combinations. Vibostolimab is an investigational anti-TIGIT antibody under evaluation.

Merck provided an update on the Phase 3 KEYNOTE-B21 trial evaluating KEYTRUDA in combination with chemotherapy for patients with high-risk endometrial cancer. The trial did not meet its primary endpoint of disease-free survival. The safety profile of KEYTRUDA was consistent with previous studies. Merck will continue to expand the role of KEYTRUDA in endometrial cancer treatment.

Merck (NYSE:MRK) has exceeded its goal of reaching 25 million women by 2025 through its global maternal health initiative, Merck for Mothers, now reaching over 30 million women worldwide. The initiative supports the UN's Sustainable Development Goal 3 by focusing on reducing maternal mortality rates and improving access to health care. Through public-private collaborations in over 70 countries, Merck for Mothers has made significant impacts in countries like India, Brazil, Kenya, Nigeria, and the United States.