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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.
Daiichi Sankyo and Merck's ifinatamab deruxtecan (I-DXd) shows promising results in treating extensive-stage small cell lung cancer (ES-SCLC) in the IDeate-Lung01 phase 2 trial. Key findings include:
- 54.8% objective response rate at 12 mg/kg dose
- Median overall survival of 11.8 months at 12 mg/kg dose
- 50% intracranial response rate in patients with brain lesions
- 12 mg/kg selected as optimal dose for further studies
The safety profile is consistent with previous trials, with no new safety signals identified. These results support the potential of B7-H3 as a target in SCLC treatment.
Merck (NYSE: MRK) will present new data for 10 investigational or approved medicines at the ESMO Congress 2024 in Barcelona. Key highlights include:
1. Overall survival (OS) data for KEYTRUDA in early-stage triple-negative breast cancer and locally advanced cervical cancer.
2. Ten-year OS data from KEYNOTE-006 and final OS data from KEYNOTE-811 for KEYTRUDA in advanced melanoma and HER2-positive gastric cancer.
3. Progress in Merck's pipeline of antibody-drug conjugates (ADCs), including patritumab deruxtecan, sacituzumab tirumotecan, and ifinatamab deruxtecan.
4. Data on WELIREG for advanced renal cell carcinoma and LENVIMA for hepatocellular carcinoma.
The presentations showcase Merck's continued progress in advancing clinical research across a broad portfolio and diverse pipeline of investigational candidates.
Merck (NYSE: MRK) and its subsidiary EyeBio have initiated the Phase 2b/3 BRUNELLO trial for Restoret™ (MK-3000) in treating diabetic macular edema (DME). MK-3000 is an investigational, potentially first-in-class tetravalent, tri-specific antibody acting as an agonist of the Wnt signaling pathway. The trial's initiation follows promising results from the Phase 1/2 AMARONE study of MK-3000 in patients with DME and neovascular age-related macular degeneration (NVAMD). Dr. David Guyer, CEO of EyeBio, emphasized the potential of MK-3000 for retinal disease patients and highlighted the significance of the BRUNELLO trial in developing new treatment options for DME.
Merck's KEYTRUDA (pembrolizumab) in combination with Padcev (enfortumab vedotin-ejfv) has received European Commission approval for first-line treatment of unresectable or metastatic urothelial carcinoma in adults. This approval follows positive results from the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.
Key findings include:
- 53% reduction in risk of death
- 55% reduction in risk of disease progression or death
This marks the first new first-line standard of care for this condition in decades, potentially extending patients' lives. KEYTRUDA is now approved for 28 indications in the EU, including three in bladder cancer.
Merck (NYSE: MRK) has announced that its top executives will participate in the Morgan Stanley 22nd Annual Global Healthcare Conference on September 5, 2024. Robert M. Davis, chairman and CEO, and Dr. Dean Y. Li, executive VP and president of Merck Research Laboratories, are scheduled for a fireside chat at 2:35 p.m. EDT.
This event presents an opportunity for investors, analysts, media, and the public to gain insights into Merck's strategies and developments. The company, known as MSD outside the US and Canada, will provide a live audio webcast of the presentation, making it accessible to a wide audience. This participation underscores Merck's commitment to transparency and engagement with stakeholders in the healthcare industry.
Merck (NYSE: MRK) has announced the discontinuation of two Phase 3 trials: KEYNOTE-867 and KEYNOTE-630. The KEYNOTE-867 trial, evaluating KEYTRUDA with stereotactic body radiotherapy (SBRT) for early-stage non-small cell lung cancer (NSCLC), was halted due to lack of improvement in event-free survival and overall survival compared to placebo plus SBRT. Additionally, higher rates of adverse events were observed in the KEYTRUDA combination.
The KEYNOTE-630 trial, assessing KEYTRUDA for adjuvant treatment of high-risk locally advanced cutaneous squamous cell carcinoma (cSCC), was stopped for futility. The study did not show statistical significance in recurrence-free survival, and overall survival results did not favor KEYTRUDA over placebo. Merck will share the ongoing data analyses with the scientific community and regulatory agencies.
Merck (NYSE: MRK) has initiated Shorespan-007, a pivotal Phase 3 clinical trial for bomedemstat, an investigational oral LSD1 inhibitor, for treating essential thrombocythemia (ET) patients who haven't received cytoreductive therapy. This trial, comparing bomedemstat to the standard chemotherapy hydroxyurea, will enroll about 300 patients globally. The primary endpoint is durable clinicohematologic response rate.
Bomedemstat is also being studied in Shorespan-006, another Phase 3 trial for ET patients intolerant to hydroxyurea. It has received FDA Orphan Drug and Fast Track Designations for ET and myelofibrosis treatment. Merck recently presented updated data from the Phase 2b Shorespan-003 trial at the ASH Annual Meeting in December 2023.
Merck (NYSE: MRK) has received European Commission approval for WINREVAIR™ (sotatercept) to treat adult patients with pulmonary arterial hypertension (PAH) in WHO Functional Class II-III. WINREVAIR is the first activin signaling inhibitor therapy for PAH approved in Europe, designed to improve exercise capacity when used with other PAH therapies.
The approval is based on the Phase 3 STELLAR trial, which showed significant improvements in six-minute walk distance and reduced risk of death or clinical worsening. WINREVAIR demonstrated an 82% reduction in the risk of death or clinical worsening compared to background therapy alone.
WINREVAIR is administered as a subcutaneous injection every 3 weeks and can be self-administered with proper training. This approval is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway.
Merck (NYSE: MRK) has announced a definitive agreement to acquire CN201, a novel investigational clinical-stage bispecific antibody, from Curon Biopharmaceutical for an upfront payment of $700 million in cash. The deal includes potential milestone payments of up to $600 million. CN201 is a next-generation CD3xCD19 bispecific antibody currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma and B-cell acute lymphocytic leukemia.
Preliminary data suggests CN201 has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well-tolerated. Merck plans to evaluate CN201 for B-cell malignancies and autoimmune diseases. The transaction is expected to close in Q3 2024, subject to regulatory approval. Merck anticipates recording a pre-tax charge of approximately $750 million, or $0.28 per share, in non-GAAP results upon closing.
Merck (NYSE: MRK) has announced the discontinuation of its Phase 3 KeyVibe-008 trial, which was evaluating a fixed-dose combination of vibostolimab and pembrolizumab (KEYTRUDA®) with chemotherapy for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). The decision was based on a recommendation from an independent Data Monitoring Committee after a pre-planned analysis showed the primary endpoint of overall survival met pre-specified futility criteria. Additionally, patients in the experimental arm experienced higher rates of adverse events compared to the control arm.
Despite this setback, Merck remains committed to advancing research in lung cancer treatment. The company is pursuing multiple registration-enabling studies, including the IDeate-Lung02 Phase 3 trial with Daiichi Sankyo, evaluating ifinatamab deruxtecan in relapsed SCLC. Merck is also exploring combinations with MK-6070, a DLL3-targeting T-cell engager, in SCLC patients.