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

PRINCETON, NJ–(BUSINESS WIRE)–March 21, 2022–

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

Key presentations include:

  • Presenting a Late-Breaking Clinical Trial of Data from the Phase 3 VALOR-HCM Study Evaluating Mavacamten in Patients with Hypertrophic Obstructive Cardiomyopathy (Obstructive HCM) with Severe Symptoms Referred for Septal Reduction Therapy (SRT) ).
  • A late-breaking clinical trial presentation of updated interim results from baseline through week 84 of the EXPLORER-LTE cohort of the MAVA-LTE study, the largest and longest reporting on 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 exercise tolerance in symptomatic obstructive HCM patients.
  • Analysis of two-week patch electrocardiogram recordings of over 5,700 elderly U.S. primary care patients with previously undiagnosed atrial fibrillation (AF) in the GUARD-AF (Reducin g stroke by screening you no one A gnosed at R ial fibrillation in the elderly D individuals) study. This randomized controlled trial helps address the critically important need for further research into the impact of early detection of AF through a screening intervention, compared to usual care, on the net clinical benefit, including reduced risk of stroke.

“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 disease,” said Roland Chen, MD, senior vice president, head of cardiovascular development and global drug development at Bristol. Myers Squibb. “We look forward to sharing these new data which reinforce the value of mavacamten as a potential treatment option for symptomatic obstructive HCM. We are also proud to continue our long-standing commitment to patients with atrial fibrillation by raising awareness of the important need for further research into the impact of early detection of AF through screening intervention.

Studies selected 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 regional social risk exposure in patients with venous thromboembolism: a national retrospective cohort study*

Colavecchia, C.

Poster – 1203-001

1203 – Vascular medicine: digital presentations on venous and thromboembolic diseases

8:30 am

Mavacamten as an alternative to surgical septal myectomy or alcohol ablation in patients with severely symptomatic hypertrophic obstructive cardiomyopathy

Desai, MY

LBCT-402-09

402 – Joint American College of Cardiology/Journal of the American College of Cardiology Late-Breaking Clinical Trials

9:30 a.m. – 9:42 a.m.

The effect of Mavacamten on cardiopulmonary exercise test performance of patients with hypertrophic obstructive cardiomyopathy in EXPLORER-HCM

Wheeler, Montana

Poster – 1005-03

1005 – Advances in the diagnosis, risk stratification and treatment of hypertrophic cardiomyopathies

9:45 a.m. – 9:55 a.m.

Outcomes by New York Heart Association class among patients with hypertrophic obstructive cardiomyopathy

Wang, Y.

Poster – 1005-05

1005 – Advances in the diagnosis, risk stratification and treatment of hypertrophic cardiomyopathies

10:00 – 10:10

Atrial Fibrillation Anticoagulation Failures During Index Hospitalization: Retrospective Observational Study from a Single Academic Center*

Patti, KG

Poster – 1358-091

1358 – Electrophysiology: Clinical Sciences 6

3:45 p.m. – 4:30 p.m.

Sunday, April 3, 2022

A Randomized Clinical Trial of Atrial Fibrillation Screening with a 14-Day Patch Monitor: Analysis of ECG Recordings from the GUARD-AF Study*

Singer, DE

Poster – 1052-09

1052 – Contributions of electrophysiology-mediated posters in atrial fibrillation II: risk factors and stroke prevention

10:30 a.m. – 10:40 a.m.

Update of Cumulative Results of Mavacamten Treatment of the EXPLORER-LTE Cohort of the MAVA-LTE Study in Patients with Hypertrophic Obstructive Cardiomyopathy

Rader, F

LBCT-406-16

406 – Joint American College of Cardiology/New England Journal of Medicine Last Minute Clinical Trials

10:45 a.m. – 10:55 a.m.

*Sponsored by the Bristol Myers Squibb-Pfizer Alliance

About Mavacamten

Mavacamten is a first-in-class oral allosteric modulator of cardiac myosin being studied for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) which is a progressive disease that thickens the walls of the heart and makes it more difficult 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 the excessive formation of myosin-actin cross-bridging which leads to hypercontractility, left ventricular hypertrophy and reduced compliance. Based on data from the EXPLORER-HCM study, the company has a U.S. PDUFA date of April 28, 2022.

In clinical and preclinical studies, mavacamten consistently reduced biomarkers of cardiac wall stress, decreased excessive cardiac contractility, increased diastolic compliance, and decreased left ventricular outflow tract (LVOT) gradients. Mavacamten is an experimental 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 defeat serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, TwitterYoutube, Facebook and Instagram.

Caution Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 relating to, among other things, the research, development and marketing of pharmaceuticals. All statements that are not statements of historical fact are, or may be deemed to be, forward-looking statements. These 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, deflect or modify any of them in the next few years. years, which 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 or implied by the statements. These risks, assumptions, uncertainties and other factors include, among others, that the results of future studies will be consistent with results to date, that mavacamten may not receive regulatory approval for the indication described in this release in the currently anticipated time frame or at all, any marketing authorization, if granted, may have significant limitations as to its use and, if approved, whether the product candidate for the indication described in this release will a commercial success. No forward-looking statement can be guaranteed. The forward-looking statements contained in this press release must be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the Cautionary Note and Discussion of Risk Factors in the report. Annual Report of Bristol Myers Squibb on Form 10-K for the year ended December 31, 2021, as updated by our subsequent quarterly reports on Form 10-Q, our 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 required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether whether as a result of new information, future events, changed circumstances or otherwise.

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CONTACT: Bristol Myers SquibbMedia Inquiries:

[email protected] Francis

[email protected]

609-529-0676Investors:

[email protected]

KEYWORD: UNITED STATES NORTH AMERICA DISTRICT OF COLUMBIA NEW JERSEY

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS RESEARCH PHARMACEUTICAL SCIENCE CARDIOLOGY BIOTECHNOLOGY

Source: Bristol Myers Squibb

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PUBLISHED: 03/21/2022 08:00 AM / DISK: 03/21/2022 08:02 AM

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