\n\u201cThe ODYSSEY-HCM trial, the largest and longest-duration study completed to date in patients with non-obstructive HCM, tested the hypothesis of whether a cardiac myosin inhibitor would improve measures of feel and function for these patients, showing clinical benefits similar to what we have seen in obstructive HCM,\u201d said Milind Desai, MD, MBA, Vice Chair in the Heart, Vascular & Thoracic Institute and Director of the HCM Center, Cleveland Clinic. \u201cThe findings of this trial help us understand that obstructive HCM and non-obstructive HCM are two unique diseases. Through long-term trials and real-world data from thousands of patients with symptomatic obstructive HCM, we have seen the meaningful impact that Camzyos<\/i> has on improving the quality of life for patients living with this condition. ODYSSEY-HCM indicates that we must consider new ways of thinking about potential treatment approaches for non-obstructive HCM. We want to thank the patients and investigators for their efforts in completing this important trial and their commitment to advancing the scientific understanding of this complex disease.\u201d\n<\/p>\n
\n\u201cWhile these results are disappointing, the ODYSSEY-HCM trial meaningfully contributes to the understanding of non-obstructive HCM, a disease where there remains a significant need for new treatment options,\u201d said Roland Chen, MD<\/a>, senior vice president, drug development, Immunology and Cardiovascular Medicines, Bristol Myers Squibb. \u201cThese findings represent the first Phase 3 clinical trial data for a cardiac myosin inhibitor in non-obstructive HCM. Importantly, these results do not change the favorable benefit-risk profile that has been consistently demonstrated across our Camzyos<\/i> clinical trials in obstructive HCM and the robust body of real-world effectiveness and safety evidence showing its benefit for people living with obstructive HCM around the world.\u201d\n<\/p>\n \nBristol Myers Squibb will work with key investigators to share detailed results with the scientific community in the future.\n<\/p>\n \nBristol Myers Squibb thanks the patients and investigators who participated in the ODYSSEY-HCM clinical trial.\n<\/p>\n About ODYSSEY-HCM \nThe dual-primary endpoints for the trial were to examine changes from baseline in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-23 CSS) and peak oxygen consumption (pVO2) at Week 48. Secondary endpoints included change from baseline in ventilatory efficiency (VE\/VCO2), NYHA functional class, N-terminal pro B-type natriuretic peptide (NT-proBNP) levels, and the Hypertrophic Cardiomyopathy Symptom Questionnaire-Shortness of Breath (HCMSQ-SoB) at Week 48.\n<\/p>\n About CAMZYOS\u00ae<\/sup> (mavacamten) CAMZYOS U.S. INDICATION IMPORTANT SAFETY INFORMATION<\/span><\/b><\/p>\n WARNING: RISK OF HEART FAILURE<\/b><\/p>\n CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.<\/b><\/p>\n Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.<\/b><\/p>\n Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with the following:<\/b><\/p>\n Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS PROGRAM.<\/b><\/p>\n CONTRAINDICATIONS<\/span><\/b><\/p>\n \nCAMZYOS is contraindicated with concomitant use of:\n<\/p>\n WARNINGS AND PRECAUTIONS<\/b><\/p>\n Heart Failure<\/b><\/p>\n \nCAMZYOS reduces systolic contraction and can cause heart failure or totally block ventricular function. Patients who experience a serious intercurrent illness (e.g., serious infection) or arrhythmia (e.g., atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.\n<\/p>\n \nAssess the patient\u2019s clinical status and LVEF prior to and regularly during treatment and adjust the CAMZYOS dose accordingly. New or worsening arrhythmia, dyspnea, chest pain, fatigue, palpitations, leg edema, or elevations in N-terminal pro-B-type natriuretic peptide (NT-proBNP) may be signs and symptoms of heart failure and should also prompt an evaluation of cardiac function.\n<\/p>\n \nAsymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.\n<\/p>\n \nInitiation of CAMZYOS in patients with LVEF <55% is not recommended. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.\n<\/p>\n CYP 450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness<\/b><\/p>\n \nCAMZYOS is primarily metabolized by CYP2C19 and CYP3A4 enzymes. Concomitant use of CAMZYOS and drugs that interact with these enzymes may lead to life-threatening drug interactions such as heart failure or loss of effectiveness.\n<\/p>\n \nAdvise patients of the potential for drug interactions, including with over-the-counter medications (such as omeprazole, esomeprazole, or cimetidine). Advise patients to inform their healthcare provider of all concomitant products prior to and during CAMZYOS treatment.\n<\/p>\n CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program<\/b><\/p>\n \nCAMZYOS is only available through a restricted program called the CAMZYOS REMS Program because of the risk of heart failure due to systolic dysfunction. Notable requirements of the CAMZYOS REMS Program include the following:\n<\/p>\n \nFurther information is available at www.CAMZYOSREMS.com<\/a> or by telephone at 1-833-628-7367.\n<\/p>\n Embryo-Fetal Toxicity<\/b><\/p>\n \nCAMZYOS may cause fetal toxicity when administered to a pregnant female, based on animal studies. Confirm absence of pregnancy in females of reproductive potential prior to treatment and advise patients to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of combined hormonal contraceptives (CHC). If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\n<\/p>\n ADVERSE REACTIONS<\/b><\/p>\n \nIn the EXPLORER-HCM trial, adverse reactions occurring in >5% of patients and more commonly in the CAMZYOS group than in the placebo group were dizziness (27% vs 18%) and syncope (6% vs 2%). There were no new adverse reactions identified in VALOR-HCM.\n<\/p>\n Effects on Systolic Function<\/span><\/p>\n \nIn the EXPLORER-HCM trial, mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups. Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period. At Week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups. In the EXPLORER-HCM trial, 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35-49%) while on treatment. In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS.\n<\/p>\n DRUG INTERACTIONS<\/b><\/p>\n Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS<\/b><\/p>\n \nCAMZYOS is primarily metabolized by CYP2C19 and to a lesser extent by CYP3A4 and CYP2C9. Inducers and inhibitors of CYP2C19 and moderate to strong inhibitors or inducers of CYP3A4 may affect the exposures of CAMZYOS.\n<\/p>\n Impact of Other Drugs on CAMZYOS:<\/span><\/b><\/p>\n Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs<\/b><\/p>\n \nCAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C19, or CYP2C9 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used in combination with CYP3A4, CYP2C19, or CYP2C9 substrates unless otherwise recommended in the Prescribing Information.\n<\/p>\n \nCertain Combined Hormonal Contraceptives (CHC): Progestin and ethinyl estradiol are CYP3A4 substrates. Concomitant use of CAMZYOS may decrease exposures of certain progestins, which may lead to contraceptive failure. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS, but if other CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\n<\/p>\n Drugs That Reduce Cardiac Contractility<\/b><\/p>\n \nExpect additive negative inotropic effects of CAMZYOS and other drugs that reduce cardiac contractility. Avoid concomitant use of CAMZYOS in patients on disopyramide, ranolazine, verapamil with a beta blocker, or diltiazem with a beta blocker as these medications and combinations increase the risk of left ventricular systolic dysfunction and heart failure symptoms and clinical experience is limited.\n<\/p>\n \nIf concomitant therapy with a negative inotrope is initiated, or if the dose of a negative inotrope is increased, monitor LVEF closely until stable doses and clinical response have been achieved.\n<\/p>\n SPECIFIC POPULATIONS<\/b><\/p>\n Pregnancy<\/b><\/p>\n \nCAMZYOS may cause fetal harm when administered to a pregnant female. Advise pregnant females about the potential risk to the fetus with maternal exposure to CAMZYOS during pregnancy. There is a pregnancy safety study for CAMZYOS. If CAMZYOS is administered during pregnancy, or if a patient becomes pregnant while receiving CAMZYOS or within 4 months after the last dose of CAMZYOS, healthcare providers should report CAMZYOS exposure by contacting Bristol Myers Squibb at 1-800-721-5072 or www.bms.com<\/a>.\n<\/p>\n Lactation<\/b><\/p>\n \nThe presence of CAMZYOS in human or animal milk, the drug\u2019s effects on the breastfed infant, or the effects on milk production are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother\u2019s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.\n<\/p>\n Females and Males of Reproductive Potential<\/b><\/p>\n \nConfirm absence of pregnancy in females of reproductive potential prior to initiation of CAMZYOS. Advise females of reproductive potential to use effective contraception during treatment with CAMZYOS and for 4 months after the last dose. CHCs containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other combined hormonal contraceptives (CHC). If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) during concomitant use and for 4 months after the last dose of CAMZYOS.\n<\/p>\n \nPlease see U.S. Full Prescribing Information<\/a>, including Boxed WARNING<\/b> and Medication Guide<\/a>.\n<\/p>\n About Bristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements \ncorporatefinancial-news\n<\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250414201642\/en\/<\/a><\/span><\/p>\n Bristol Myers Squibb<\/b><\/p>\n Media Inquiries:
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<\/span><\/b>ODYSSEY-HCM (NCT05582395<\/a>) is a Phase 3 randomized, double-blind, placebo-controlled trial that enrolled 580 adult patients with symptomatic (NYHA class II or III) non-obstructive hypertrophic cardiomyopathy (nHCM) worldwide.\n<\/p>\n
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<\/span><\/b>CAMZYOS\u00ae<\/sup> (mavacamten) is the first and only cardiac myosin inhibitor approved in the U.S., indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms, and in the European Union, indicated for the treatment of symptomatic (NYHA, class II-III) oHCM in adult patients. It has also received regulatory approvals in more than 50 countries and regions across five continents. CAMZYOS is a selective, reversible, allosteric inhibitor of cardiac myosin. CAMZYOS modulates the number of myosin heads that can enter \u201con actin\u201d (power-generating) states, thus reducing the probability of force-producing (systolic) and residual (diastolic) cross-bridge formation. Excess myosin actin cross-bridge formation and dysregulation of the super-relaxed state are mechanistic hallmarks of HCM. CAMZYOS shifts the overall myosin population towards an energy-sparing, recruitable, super-relaxed state. In oHCM patients, myosin inhibition with CAMZYOS reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures. These effects on the heart translate to improvement in symptoms and ability to be active in symptomatic patients with oHCM.\n<\/p>\n
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<\/span><\/b>CAMZYOS\u00ae<\/sup> (mavacamten) is a cardiac myosin inhibitor indicated for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms.\n<\/p>\n\n
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<\/span><\/b>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<\/a> or follow us on LinkedIn<\/a>, X<\/a>, YouTube<\/a>, Facebook<\/a> and Instagram<\/a>.\n<\/p>\n
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<\/span><\/b>This press release contains \u201cforward-looking statements\u201d 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, the possibility of unfavorable results from further clinical trials involving Camzyos <\/i>(mavacamten) and whether Camzyos<\/i> for the additional indication described in this release will be successfully developed and commercialized. 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\u2019s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb\u2019s Annual Report on Form 10-K for the year ended December 31, 2024, 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.\n<\/p>\n<\/p>\n
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