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05-May-2021

Bristol Myers Squibb Presents New Clinical and Real-World Data on Mavacamten and Obstructive Hypertrophic Cardiomyopathy at Upcoming American College of Cardiology’s 70th Annual Scientific Session

  • New analysis of EXPLORER-HCM trial assessing impact of mavacamten on patient’s health status to be presented as late-breaking oral presentation
  • Interim results of EXPLORER long-term extension study of mavacamten safety and efficacy data in patients with obstructive hypertrophic cardiomyopathy (oHCM) also to be presented

Bristol Myers Squibb (NYSE: BMY) today announced that data from multiple studies across the company’s clinical program investigating mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM) will be presented at the upcoming American College of Cardiology’s 70th Annual Scientific Session (ACC.21), being held virtually May 15 to May 17, 2021.

Key presentations include:

  • A late-breaking oral presentation reporting results from a new analysis of data from the EXPLORER-HCM Phase 3 trial of mavacamten in patients with oHCM, which tested the impact of mavacamten on patients’ health status (symptoms, function and quality of life) as measured by the Kansas City Cardiomyopathy Questionnaire. These data will be presented as part of the Featured Clinical Research I Session in the Hot Topics Channel on Saturday, May 15 from 12:15 – 1:30 p.m. EDT.
  • A moderated poster session highlighting interim results from MAVA-LTE, an ongoing, dose-blinded 5-year extension study of the EXPLORER-HCM Phase 3 trial. Findings from the interim analysis demonstrated that in patients with oHCM, mavacamten was well tolerated and showed durable improvement in left ventricular outflow tract (LVOT) gradients, diastolic function, N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and symptoms.
  • A poster presentation of results from a real-world data analysis measuring the clinical and economic burden of oHCM in the United States, which found the condition is associated with substantial healthcare resource utilization and costs.

“These data add to the growing body of evidence that further supports the goal of addressing a high unmet medical need in patients with oHCM with mavacamten as a first-in-class medicine,” said Jay Edelberg, M.D., Ph.D., head, Heart Failure and Cardiomyopathy Development at Bristol Myers Squibb. “We look forward to potentially bringing this therapy to oHCM patients early next year.”

Mavacamten Presentations

  • Health Status Benefits of Mavacamten in Patients with Symptomatic Obstructive Cardiomyopathy: Results From the EXPLORER-HCM Randomized Clinical Trial
    • Author: John A. Spertus
    • Session 403-09 – Featured Clinical Research I
    • Session Type: Late-Breaking Clinical Trials, Hot Topics Channel
    • Saturday, May 15: 12:15 – 12:25 p.m. EDT
  • Long-Term Safety of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy: Interim Results of the MAVA-Long Term Extension (LTE) Story
    • Author: Florian Rader
    • Session 1033-03 – Advances in Hypertrophic Cardiomyopathy
    • Session Type: Moderated Poster Contributions, eAbstract Site
    • Saturday, May 15: 12:30 – 12:40 p.m. EDT
  • Clinical and Economic Burden of Obstructive Hypertrophic Cardiomyopathy in the United States
    • Author: Sneha S. Jain
    • Session 2192 – Heart Failure and Cardiomyopathies: Population Science 1
    • Session Type: Poster Contributions, eAbstract Site
    • Saturday, May 15: 2:45 – 3:30 p.m. EDT

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy, or HCM, is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of debilitating symptoms and cardiac dysfunction. HCM is estimated to affect one in every 500 people.

The most frequent cause of HCM is mutations in the heart muscle proteins of the sarcomere. In either obstructive or non-obstructive HCM patients, exertion can result in fatigue or shortness of breath, interfering with a patient’s ability to participate in activities of daily living. HCM has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death, with mortality among HCM patients shown to be approximately three-fold higher than the U.S. general population at similar ages.

There are currently approximately 160,000 to 200,000 people diagnosed with symptomatic obstructive HCM across the U.S. and EU, with no existing effective drug treatment options beyond limited symptomatic relief.

About Mavacamten

Mavacamten is a potential first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility and increased diastolic compliance.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedInTwitterYouTubeFacebook and Instagram.

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Last Updated: 05-May-2021