Merck Data at ACC.25 Highlight Innovative Advancements and Commitment to Improving Outcomes for People Living with Cardiovascular Disease
Merck (MRK) announced new clinical and outcomes research data presentations at the American College of Cardiology's Annual Scientific Session (ACC.25) in Chicago, March 29-31. The highlight is the Phase 3 ZENITH trial results for WINREVAIR™ (sotatercept-csrk) in treating pulmonary arterial hypertension (PAH) patients, which concluded early due to overwhelming efficacy.
The company will present four outcomes research presentations on cholesterol management, including real-world data on healthcare utilization costs for dyslipidemia treatment and LDL-C measurement patterns. Research focuses on barriers to achieving LDL-C goals, noting that nearly two-thirds of individuals don't reach their targets. The presentations include a systematic review of residual atherosclerotic cardiovascular disease risk in statin users and a model estimating the impact of lipid-lowering therapy treatment patterns.
Merck (MRK) ha annunciato nuove presentazioni di dati di ricerca clinica e sugli esiti durante la Sessione Scientifica Annuale del Collegio Americano di Cardiologia (ACC.25) a Chicago, dal 29 al 31 marzo. Il punto culminante sono i risultati della fase 3 dello studio ZENITH per WINREVAIR™ (sotatercept-csrk) nel trattamento dei pazienti affetti da ipertensione arteriosa polmonare (PAH), che è stato concluso anticipatamente a causa dell'efficacia straordinaria.
L'azienda presenterà quattro presentazioni di ricerca sugli esiti sulla gestione del colesterolo, inclusi dati reali sui costi di utilizzo dei servizi sanitari per il trattamento della dislipidemia e sui modelli di misurazione del LDL-C. La ricerca si concentra sulle barriere al raggiungimento degli obiettivi di LDL-C, notando che quasi due terzi degli individui non raggiungono i loro obiettivi. Le presentazioni includono una revisione sistematica del rischio residuo di malattia cardiovascolare aterosclerotica negli utenti di statine e un modello che stima l'impatto dei modelli di trattamento della terapia ipolipemizzante.
Merck (MRK) anunció nuevas presentaciones de datos de investigación clínica y de resultados en la Sesión Científica Anual del Colegio Americano de Cardiología (ACC.25) en Chicago, del 29 al 31 de marzo. El punto culminante son los resultados del ensayo de fase 3 ZENITH para WINREVAIR™ (sotatercept-csrk) en el tratamiento de pacientes con hipertensión arterial pulmonar (HAP), que concluyó anticipadamente debido a su eficacia abrumadora.
La compañía presentará cuatro presentaciones de investigación sobre resultados en la gestión del colesterol, incluidos datos del mundo real sobre los costos de utilización de la atención médica para el tratamiento de la dislipidemia y los patrones de medición de LDL-C. La investigación se centra en las barreras para alcanzar los objetivos de LDL-C, señalando que casi dos tercios de las personas no alcanzan sus metas. Las presentaciones incluyen una revisión sistemática del riesgo residual de enfermedad cardiovascular aterosclerótica en usuarios de estatinas y un modelo que estima el impacto de los patrones de tratamiento de la terapia para reducir lípidos.
머크 (MRK)는 3월 29일부터 31일까지 시카고에서 열리는 미국심장학회 연례 과학 세션 (ACC.25)에서 새로운 임상 및 결과 연구 데이터 발표를 발표했습니다. 주요 내용은 폐동맥 고혈압 (PAH) 환자 치료를 위한 WINREVAIR™ (sotatercept-csrk)의 3상 ZENITH 시험 결과로, 탁월한 효능으로 조기 종료되었습니다.
회사는 이상지질혈증 치료를 위한 의료 이용 비용에 대한 실제 데이터와 LDL-C 측정 패턴을 포함하여 콜레스테롤 관리에 대한 네 가지 결과 연구 발표를 진행할 예정입니다. 연구는 LDL-C 목표 달성에 대한 장벽에 초점을 맞추고 있으며, 거의 3분의 2의 개인이 목표에 도달하지 못한다는 점을 지적하고 있습니다. 발표 내용에는 스타틴 사용자에서의 잔여 동맥경화성 심혈관 질환 위험에 대한 체계적인 검토와 지질 저하 요법 치료 패턴의 영향을 추정하는 모델이 포함됩니다.
Merck (MRK) a annoncé de nouvelles présentations de données de recherche clinique et sur les résultats lors de la Session Scientifique Annuelle du Collège Américain de Cardiologie (ACC.25) à Chicago, du 29 au 31 mars. Le point fort est les résultats de l'essai de phase 3 ZENITH pour WINREVAIR™ (sotatercept-csrk) dans le traitement des patients atteints d'hypertension artérielle pulmonaire (HAP), qui a été conclu prématurément en raison d'une efficacité écrasante.
L'entreprise présentera quatre présentations de recherche sur les résultats concernant la gestion du cholestérol, y compris des données réelles sur les coûts d'utilisation des soins de santé pour le traitement de la dyslipidémie et les modèles de mesure du LDL-C. La recherche se concentre sur les obstacles à l'atteinte des objectifs de LDL-C, notant que près des deux tiers des individus n'atteignent pas leurs cibles. Les présentations incluent une revue systématique du risque résiduel de maladie cardiovasculaire athéroscléreuse chez les utilisateurs de statines et un modèle estimant l'impact des schémas de traitement de la thérapie hypolipémiante.
Merck (MRK) gab neue klinische und Ergebnissforschungsdaten während der Jahrestagung des American College of Cardiology (ACC.25) in Chicago vom 29. bis 31. März bekannt. Das Highlight sind die Ergebnisse der Phase-3-Studie ZENITH für WINREVAIR™ (sotatercept-csrk) bei der Behandlung von Patienten mit pulmonaler arterieller Hypertonie (PAH), die aufgrund überwältigender Wirksamkeit vorzeitig beendet wurde.
Das Unternehmen wird vier Präsentationen zur Ergebnissforschung im Bereich Cholesterinmanagement vorstellen, einschließlich realer Daten zu den Kosten der Gesundheitsnutzung für die Behandlung von Dyslipidämie und zu den Mustern der LDL-C-Messung. Die Forschung konzentriert sich auf Hindernisse beim Erreichen der LDL-C-Ziele und stellt fest, dass fast zwei Drittel der Personen ihre Ziele nicht erreichen. Die Präsentationen umfassen eine systematische Übersicht über das Residualrisiko für atherosklerotische Herz-Kreislauf-Erkrankungen bei Statin-Nutzern sowie ein Modell zur Schätzung der Auswirkungen von Therapie-Mustern zur Senkung von Lipiden.
- ZENITH Phase 3 trial concluded early due to overwhelming efficacy
- Expanding research portfolio in cardiovascular disease management
- Strong clinical trial results supporting WINREVAIR's effectiveness in PAH treatment
- Nearly two-thirds of patients fail to reach LDL-C goals in current treatment approaches
Insights
Merck's announcement about the Phase 3 ZENITH trial for WINREVAIR™ represents a significant clinical development with positive commercial implications. The trial, evaluating WINREVAIR in high-risk pulmonary arterial hypertension (PAH) patients with WHO functional class III or IV, was concluded early due to "overwhelming efficacy" - a rare occurrence in clinical trials that signals exceptionally positive results.
This development is particularly meaningful as WINREVAIR (sotatercept-csrk) received FDA approval just recently in March 2024. The ZENITH data could potentially expand the drug's label to include the most severe PAH patients, representing a critical commercial opportunity in a high-unmet-need population. While PAH affects relatively few patients, treatments command premium pricing due to orphan drug status, making this a potentially valuable addition to Merck's revenue stream.
The company's cardiovascular franchise may also benefit from the four presentations on cholesterol management, particularly as these highlight substantial treatment gaps - with nearly
While the press release doesn't provide the actual efficacy data (to be presented March 29-31), the early trial termination language suggests potentially practice-changing results that could strengthen Merck's position in the specialized PAH treatment landscape.
The early termination of Merck's ZENITH trial due to "overwhelming efficacy" represents a potential medical breakthrough for the most vulnerable PAH patients. WHO functional class III and IV patients face mortality rates as high as
WINREVAIR's mechanism as an activin signaling inhibitor represents a novel therapeutic approach in PAH. Unlike traditional vasodilators, it targets the underlying vascular remodeling process, potentially modifying disease progression rather than just managing symptoms. The fact that this approach showed such compelling results in the highest-risk patients suggests potential disease-modifying properties that existing PAH therapies lack.
The clinical significance extends beyond PAH, as this activin signaling pathway has implications across multiple cardiopulmonary conditions. Success here might validate this mechanism for exploration in related diseases, expanding the potential therapeutic applications.
The cholesterol management research also addresses a critical healthcare challenge - the persistent treatment gap in lipid management despite clear guidelines and available therapies. This research may highlight systemic barriers to effective cholesterol management that impact cardiovascular outcomes nationwide.
While we await the specific data at ACC.25, the language suggests potentially practice-changing results that could establish WINREVAIR as a cornerstone therapy for high-risk PAH patients who currently have effective options.
Data from Phase 3 ZENITH trial evaluating WINREVAIR™ (sotatercept-csrk) when added to background therapy in adults with pulmonary arterial hypertension (PAH, Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality to be featured as a late-breaking presentation
New research highlights gaps and barriers for patients to achieve low-density lipoprotein cholesterol (LDL-C) goals and the impact on patient outcomes and healthcare utilization, underscoring the urgency to treat to LDL-C goals
Merck will present results from the Phase 3 ZENITH trial evaluating WINREVAIR™ (sotatercept-csrk) when added to background therapy in adults with pulmonary arterial hypertension (PAH, Group 1 PH) WHO* functional class (FC) III or IV at high risk of mortality. These results will be shared as an oral presentation in a late-breaking session on Monday, March 31 during the Clinical and Investigative Horizons I session from 10:00-11:00 a.m. ET/9:00-10:00 a.m. CT (LBA402-16).
“Merck has a long legacy of making an impact in cardiovascular disease, and since we introduced our first therapy more than 60 years ago, we have remained committed to advancing innovative research to better understand and help improve the lives of patients with cardiovascular disease,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “We are particularly thrilled to share research from the Phase 3 ZENITH trial evaluating WINREVAIR in PAH as a late-breaking presentation. ZENITH is the first study in PAH in which the interim analysis led to an early conclusion due to overwhelming efficacy and adds to the growing body of data evaluating WINREVAIR in a broad spectrum of patients with PAH.”
Four outcomes research presentations focused on cholesterol management from Merck will also be shared during the meeting. These include two presentations evaluating real-world data: the first highlights healthcare utilization and costs among patients treated for dyslipidemia in a
“Our commitment to improving the lives of patients includes driving analyses of observational data to provide valuable insights into the barriers to achieving LDL-C goals in order to manage atherosclerotic cardiovascular disease,” said Dr. Bjorn Oddens, senior vice president and head of value and implementation, Merck Research Laboratories. “Low-density lipoprotein cholesterol is an established and modifiable risk factor for the development of atherosclerotic cardiovascular disease, a disease which accounts for 85 percent of cardiovascular deaths, but nearly two-thirds of individuals do not reach their LDL-C goals. Research presented at ACC aims to provide the cardiovascular community with insights into existing gaps in management, the impact on patient outcomes and healthcare systems and opportunities for improvement, with the ultimate goal of helping more patients better manage their LDL-C.”
Key data from Merck to be presented at ACC.25:
- First presentation of results from the Phase 3 ZENITH trial evaluating WINREVAIR when added to background therapy in patients with PAH FC III or IV at high risk of mortality (Abstract #LBA402-16; Clinical and Investigative Horizons I);
- A systematic review and meta-analysis evaluating the residual ASCVD risk in statin users in the real-world setting (Abstract #1062-36; Cardiovascular Disease Prevention 03);
-
Real-world data evaluating the frequency of LDL-C measurement and its association with patient characteristics among adults prescribed LLT in the
U.S. (Abstract #1062-19; Cardiovascular Disease Prevention 03); -
Presentation of a model to estimate the benefits of non-statin LLT use in terms of clinical (LDL-C and ASCVD event reduction) and economic (cost reduction) impact on the
U.S. health system (Abstract #977-03; Costs of Cardiovascular Preventive Care: Implications Across Stakeholders); -
Poster presentation estimating the association between healthcare resource use and treatment patterns among adults on LLT across various levels of risk in a large
U.S. health system (Abstract #977-15; Costs of Cardiovascular Preventive Care: Implications Across Stakeholders).
Details on key abstracts for Merck:
PAH |
|
Efficacy and safety of sotatercept in high-risk patients with pulmonary arterial hypertension: results from ZENITH Phase 3 trial. M. Humbert. |
Abstract #LBA402-16; Clinical and Investigative Horizons I on Monday, March 31, 10:00-11:00 a.m. ET/9:00-10:00 a.m. CT |
Burden of pulmonary arterial hypertension (PAH) on women across regions: multinational patient qualitative study. I. Preston. |
Abstract #66; Pulmonary Vascular Disease 07 on Sunday, March 30, 11:30 a.m.-12:30 p.m. ET/10:30-11:30 a.m. CT |
Atherosclerotic Cardiovascular Disease |
|
Clinical and economic burden of adding ezetimibe therapy in patients with atherosclerotic cardiovascular disease. T. Galvain. |
Abstract #977-03; Costs of Cardiovascular Preventive Care: Implications Across Stakeholders on Sunday, March 30, 3:00-5:00 p.m. ET/2:00-4:00 p.m. CT |
Healthcare resource use (HCRU) and costs among adults on lipid lowering therapy (LLT) with and at risk for atherosclerotic cardiovascular disease (ASCVD) events in a US integrated delivery system. A. Victores. |
Abstract #977-15; Costs of Cardiovascular Preventive Care: Implications Across Stakeholders on Sunday, March 30, 3:00-5:00 p.m. ET/2:00-4:00 p.m. CT |
Frequency of LDL-C measurement among patients prescribed lipid lowering therapy (LLT) in the US. A. Victores. |
Abstract #1062-19; Cardiovascular Disease Prevention 03 on Saturday, March 29, 1:30-2:30 p.m. ET/12:30-1:30 p.m. CT |
Residual atherosclerotic cardiovascular disease risk in statin users – a systematic review and meta-analysis. A.H. Watanabe. |
Abstract #1062-36; Cardiovascular Disease Prevention 03 on Saturday, March 29, 1:30-2:30 p.m. ET/12:30-1:30 p.m. CT |
Heart Failure |
|
Exploring barriers to optimization of medical therapy and the role of checklist-based decision support in heart failure. B. Montelaro. |
Abstract #1132-177; Heart Failure and Cardiomyopathies 06 on Sunday, March 30, 10:00-11:00 a.m. ET/9:00-10:00 a.m. CT |
Worsening heart failure events are associated with new initiation of guideline directed medical therapy among patients with heart failure with reduced ejection fraction. A. Ambrosy. |
Abstract #1215-146; Heart Failure and Cardiomyopathies 10 On Sunday, March 30, 4:00-5:00 p.m. ET/3:00-4:00 p.m. CT
|
*World Health Organization
About WINREVAIR™ (sotatercept-csrk) for injection, for subcutaneous use, 45 mg, 60 mg
WINREVAIR is FDA-approved for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 PH) to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events. WINREVAIR is the first activin signaling inhibitor therapy approved to treat PAH. WINREVAIR improves the balance between pro-proliferative and anti-proliferative signaling to modulate vascular proliferation. In preclinical models, WINREVAIR induced cellular changes that were associated with thinner vessel walls, partial reversal of right ventricular remodeling, and improved hemodynamics.
WINREVAIR is the subject of a licensing agreement with Bristol Myers Squibb.
Selected Safety Information for WINREVAIR in the
WINREVAIR may increase hemoglobin (Hgb). Severe erythrocytosis may increase the risk of thromboembolic events or hyperviscosity syndrome. Monitor Hgb before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter, to determine if dose adjustments are required.
WINREVAIR may decrease platelet count. Severe thrombocytopenia may increase the risk of bleeding. Thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Do not initiate treatment if platelet count is <50,000/mm3. Monitor platelets before each dose for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine whether dose adjustments are required.
In clinical studies, serious bleeding (e.g., gastrointestinal, intracranial hemorrhage) was reported in
WINREVAIR may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use an effective method of contraception during treatment with WINREVAIR and for at least 4 months after the final dose. Pregnancy testing is recommended for females of reproductive potential before starting WINREVAIR treatment.
Based on findings in animals, WINREVAIR may impair female and male fertility. Advise patients on the potential effects on fertility.
The most common adverse reactions occurring in the phase 3 clinical trial (≥
Because of the potential for serious adverse reactions in the breastfed child, advise patients that breastfeeding is not recommended during treatment with WINREVAIR, and for 4 months after the final dose.
Merck’s focus on cardiovascular disease
Merck has a long history of making an impact in cardiovascular disease. More than 60 years ago, we introduced our first cardiovascular therapy – and our scientific efforts to understand cardiovascular-related disorders have continued. Cardiovascular disease continues to be one of the most serious health challenges of the 21st century. Approximately 19 million people across the globe die every year, and in
Advancements in the treatment of cardiovascular disease can make a critical difference for patients around the world. At Merck, we strive for scientific excellence and innovation in all stages of research, from discovery through approval and life cycle management. We work with experts throughout the cardiovascular and pulmonary community to advance research that can help improve the lives of patients globally.
About Merck
At Merck, known as MSD outside of
Forward-Looking Statement of Merck & Co., Inc.,
This news release of Merck & Co., Inc.,
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in
The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2024 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).
Please see Prescribing Information for WINREVAIR (sotatercept-csrk) at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_pi.pdf , Patient Information for WINREVAIR at http://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ppi.pdf , and Instructions for Use for WINREVAIR (1-vial kit, 2-vial kit) at https://www.merck.com/product/usa/pi_circulars/w/winrevair/winrevair_ifu_1-vial_2-vial_kits.pdf.
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FAQ
What are the key findings from Merck's ZENITH trial for WINREVAIR presented at ACC.25?
How many research presentations is MRK delivering on cholesterol management at ACC.25?
What percentage of patients fail to reach their LDL-C goals according to Merck's research?
When and where is Merck presenting the ZENITH trial results at ACC.25?
