Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (MRK) announced new clinical and real-world data presentations for GARDASIL®9, their 9-valent HPV vaccine, at the International Papillomavirus Conference (IPVC) 2024 in Edinburgh. The presentations include results from the BROADEN and PROGRESS studies focusing on oral HPV infection prevalence and HPV-related cancers.
The data reinforces the importance of HPV vaccination for both males and females aged 9-45, highlighting that disease-causal HPV infection can occur later in life. Globally, approximately 666,000 new diagnoses of certain HPV-related cancers occur annually in men and women. The studies emphasize the growing incidence of HPV-related oropharyngeal and head and neck cancers, particularly in men.
Merck (NYSE: MRK) has announced its participation in the upcoming UBS Global Healthcare Conference. The company will be represented by Jannie Oosthuizen, president of Human Health U.S., and Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development at Merck Research Laboratories. The fireside chat is scheduled for Wednesday, Nov. 13, 2024, at 12:30 p.m. EST / 9:30 a.m. PST. A live audio webcast will be available for investors, analysts, media, and the general public.
Merck reported strong Q3 2024 financial results with total worldwide sales of $16.7 billion, up 4% from Q3 2023. KEYTRUDA sales grew 17% to $7.4 billion, while new launch WINREVAIR achieved sales of $149 million. Animal Health sales increased 6% to $1.5 billion. GAAP EPS was $1.24 and Non-GAAP EPS was $1.57, both including a $0.79 per share net charge from business development transactions. The company narrowed its full-year 2024 outlook, expecting worldwide sales between $63.6-64.1 billion and Non-GAAP EPS between $7.72-7.77.
Merck (MRK) and Moderna have initiated INTerpath-009, a Phase 3 clinical trial evaluating V940 (mRNA-4157) combined with KEYTRUDA for patients with resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC). The trial targets patients who didn't achieve complete response after neoadjuvant KEYTRUDA plus platinum-based chemotherapy. This marks the third Phase 3 trial for V940, focusing on earlier cancer stages. Patient enrollment has begun in Canada, expanding the companies' collaborative INTerpath clinical program which includes trials for melanoma, lung cancer, cutaneous squamous cell carcinoma, renal cell carcinoma, and urothelial carcinoma.
Merck (MRK) has received two new European Commission approvals for KEYTRUDA in gynecologic cancers, marking its 30th EU approval. The first approval is for KEYTRUDA with carboplatin and paclitaxel for first-line treatment of primary advanced or recurrent endometrial carcinoma. The second is for KEYTRUDA with chemoradiotherapy for FIGO Stage III-IVA locally advanced cervical cancer.
Clinical trials showed significant improvements: In NRG-GY018/KEYNOTE-868, the KEYTRUDA combination reduced disease progression risk by 70% in dMMR patients and 40% in pMMR patients. In KEYNOTE-A18, the treatment demonstrated meaningful improvements in overall survival and progression-free survival compared to chemoradiotherapy alone.
Merck's CAPVAXIVE receives CDC's ACIP recommendation for pneumococcal vaccination in adults aged 50 and older, lowering the previous age-based recommendation from 65. Based on CDC surveillance data, CAPVAXIVE covers serotypes responsible for approximately 84% of invasive pneumococcal disease cases, compared to 52% covered by PCV20. The vaccine is indicated for active immunization against invasive disease and pneumonia caused by 21 Streptococcus pneumoniae serotypes in adults 18 years and older. The recommendation includes a single dose for adults 50+ and those 19-49 with certain medical conditions who haven't received previous pneumococcal conjugate vaccines.
Gilead Sciences (GILD) and Merck (MRK) announced positive Phase 2 data for their investigational oral once-weekly combination regimen of islatravir and lenacapavir for HIV treatment. The study showed that 94.2% of participants maintained viral suppression at Week 48 after switching from daily Biktarvy to the weekly regimen. Key findings include:
- Zero participants had a viral load ≥50 copies/mL at Week 48
- Treatment-related adverse events were experienced by 19.2% of participants in the islatravir + lenacapavir group
- No grade 3 or 4 treatment-related adverse events were reported
- The combination is advancing to Phase 3 trials
This investigational regimen has the potential to become the first weekly oral HIV treatment, offering a novel option for people living with HIV.
Merck (NYSE: MRK) announced positive results from the Phase 2b/3 clinical trial of clesrovimab, an investigational monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease. The trial met all prespecified endpoints, showing:
- 60.4% reduction in RSV-associated medically attended lower respiratory infections (MALRI)
- 84.2% reduction in RSV-associated hospitalizations
- 90.9% reduction in RSV-associated lower respiratory infection hospitalizations
- 91.7% reduction in severe MALRI
Clesrovimab demonstrated a comparable safety profile to palivizumab in a separate Phase 3 trial for at-risk infants. Merck aims to make clesrovimab available as early as the 2025-26 RSV season, potentially becoming the first immunization to protect both healthy and at-risk infants with a single dose regardless of weight.
Exelixis (EXEL) and Merck (MRK) have announced a clinical development collaboration to evaluate combinations of Exelixis' investigational tyrosine kinase inhibitor zanzalintinib with Merck's therapies in head and neck cancer and renal cell carcinoma (RCC). The collaboration includes:
1. A phase 3 trial combining zanzalintinib with KEYTRUDA (pembrolizumab) for head and neck squamous cell carcinoma (HNSCC).
2. A phase 1/2 trial and two phase 3 trials combining zanzalintinib with WELIREG (belzutifan) for RCC.
Merck will supply KEYTRUDA for the ongoing STELLAR-305 trial in HNSCC and sponsor the RCC trials. Exelixis will co-fund some studies and supply zanzalintinib and cabozantinib. Exelixis retains global commercial rights to zanzalintinib.
Merck (NYSE: MRK) announced plans to present new research findings at IDWeek 2024 in Los Angeles, showcasing its diverse vaccines and infectious disease portfolio. Key presentations include:
1. Detailed results from the Phase 2b/3 trial of clesrovimab (MK-1654), an investigational monoclonal antibody for RSV prevention in infants.
2. Data from the Phase 3 STRIDE-8 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) in adults 18-64 years at increased risk of pneumococcal disease.
3. Week 48 data from a Phase 2 study on a once-weekly oral combination of islatravir and lenacapavir for HIV-1 treatment.
The company will present over 40 data presentations across vaccines, antibacterials, and antivirals, demonstrating its commitment to addressing global health needs in infectious diseases.