Bristol Myers Squibb to Demonstrate the Strength of its Growing Cardiovascular Portfolio at the American College of Cardiology’s 71st Annual Scientific Session

By: Bristol Myers Squibb via Business Wire

March 21, 2022 at 08:00 AM EDT

New data, including two late-breaking clinical trial presentations on mavacamten and a new analysis of the GUARD-AF study, reinforce the company’s continued commitment to those living with cardiovascular disease

Bristol Myers Squibb (NYSE: BMY) today announced that data from its cardiovascular portfolio will be presented at the American College of Cardiology’s 71st Annual Scientific Session (ACC.22), taking place in Washington, DC, and virtually, from April 2-4, 2022. Data from clinical and real-world studies will be featured, including two late-breaking clinical trial presentations from the mavacamten development program, showcasing the company’s leading cardiovascular research and commitment to improving the lives of patients.

Key presentations include:

A late-breaking clinical trial presentation of data from the Phase 3 VALOR-HCM study evaluating mavacamten in patients with obstructive hypertrophic cardiomyopathy (obstructive HCM) with severe symptoms referred for septal reduction therapy (SRT).
A late-breaking clinical trial presentation of updated interim results from baseline up to Week 84 of the EXPLORER-LTE cohort of the MAVA-LTE study, the largest and longest report of mavacamten in patients with symptomatic obstructive HCM.
An analysis of the EXPLORER-HCM study exploring the impact of mavacamten on a range of cardiopulmonary exercise test (CPET) parameters to characterize exercise capacity and submaximal exertional tolerance in symptomatic obstructive HCM patients.
Analysis of two-week patch electrocardiogram recordings from over 5,700 older U.S. primary care patients with previously undiagnosed atrial fibrillation (AF) in the GUARD-AF (ReducinG stroke by screening for UndiAgnosed atRial fibrillation in elderly inDividuals) study. This randomized controlled trial helps address the critically important need for further research on the impact of earlier detection of AF by a screening intervention, compared to usual care, on net clinical benefit, including reduction of stroke risk.

“This is an exciting time for our cardiovascular franchise, and our presence at ACC this year underscores our continued progress in the treatment of cardiovascular conditions,” said Roland Chen, M.D., senior vice president, head of cardiovascular development and global drug development at Bristol Myers Squibb. “We look forward to sharing these new data that reinforce the value of mavacamten as a potential treatment option for symptomatic obstructive HCM. We are also proud to continue our longstanding commitment to patients with atrial fibrillation by raising awareness of the significant need for further research on the impact of earlier detection of AF by a screening intervention.”

Selected studies by Bristol Myers Squibb and the Bristol Myers Squibb-Pfizer Alliance at ACC.22 include:

Abstract Title	Primary Author	Type/#	Session Title	Time
*Saturday, April 2, 2022*
Medication adherence associated with area-level social risk exposure among patients with venous thromboembolism: a national retrospective cohort study*	Colavecchia, C	Poster – 1203-001	1203 - Vascular Medicine: Venous and Thromboembolic Disease Digital Presentations	8:30 AM
Mavacamten As An Alternative To Surgical Septal Myectomy Or Alcohol Ablation In Patients With Severely Symptomatic Obstructive Hypertrophic Cardiomyopathy	Desai, M Y	LBCT - 402-09	402 – Joint American College of Cardiology/Journal of the American College of Cardiology Late-Breaking Clinical Trials	9:30 AM - 9:42 AM
The Effect of Mavacamten on Cardiopulmonary Exercise Testing Performance of Patients with Obstructive Hypertrophic Cardiomyopathy in EXPLORER-HCM	Wheeler, MT	Poster – 1005-03	1005 - Progress in Diagnosis, Risk Stratification and Treatment of Hypertrophic Cardiomyopathies	9:45 AM - 9:55 AM
Outcomes by New York Heart Association Class Among Patients with Obstructive Hypertrophic Cardiomyopathy	Wang, Y	Poster – 1005-05	1005 - Progress in Diagnosis, Risk Stratification and Treatment of Hypertrophic Cardiomyopathies	10:00 AM - 10:10 AM
Failures to anticoagulate atrial fibrillation during index hospitalization: a single academic center retrospective observational study*	Patti, KG	Poster – 1358-091	1358 - Electrophysiology: Clinical Science 6	3:45 PM – 4:30 PM
*Sunday, April 3, 2022*
A Randomized Clinical Trial of Screening for Atrial Fibrillation with a 14-day patch monitor: Analysis of ECG recordings from the GUARD-AF Study*	Singer, D E	Poster – 1052-09	1052 - Electrophysiology Moderated Poster Contributions in Atrial Fibrillation II: Risk Factors and Stroke Prevention	10:30 AM - 10:40 AM
Updated Cumulative Results Of Treatment With Mavacamten From The EXPLORER-LTE Cohort Of The MAVA-LTE Study In Patients With Obstructive Hypertrophic Cardiomyopathy	Rader, F	LBCT - 406-16	406 - Joint American College of Cardiology/New England Journal of Medicine Late-Breaking Clinical Trials	10:45 AM - 10:55 AM
*Sponsored by the Bristol Myers Squibb-Pfizer Alliance

About Mavacamten

Mavacamten is a first-in-class, oral, allosteric modulator of cardiac myosin being investigated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) which is a progressive disease that thickens the heart walls and makes it harder for the heart to expand normally and fill with blood. It is a selective cardiac myosin inhibitor that targets the underlying pathophysiology of obstructive HCM.

Mavacamten has been shown to reduce cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. Based on data from the EXPLORER-HCM study, the company has a PDUFA date in the U.S. of April 28, 2022.

In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility, increased diastolic compliance and lessened left ventricular outflow tract (LVOT) gradients. Mavacamten is an investigational therapy and is not approved for use in any country.

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.

Cautionary Statement Regarding Forward-Looking Statements

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 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, that future study results will be consistent with the results to date, that mavacamten may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all, any marketing approvals, if granted, may have significant limitations on their use, and, if approved, whether such product candidate for such indication 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, 2021, 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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