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 70 th 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."
- 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.
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 LinkedIn , Twitter , YouTube , Facebook and Instagram .
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that future study results will be consistent with the results to date, that mavacamten may not receive regulatory approval for the indication(s) described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication(s) described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb's business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.
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