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
PRINCETON, N.J.–(BUSINESS WIRE)– 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||PrimaryAuthor||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|
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.