Discover the Impact of CAMZYOS® Over Time Supported by ~3.5 Years of Data1,2

Explore this page:    |    Primary Endpoint    |    LVOT Gradient    |    NYHA Class    |   Cardiac Biomarker: NT-proBNP

Primary Endpoint (EXPLORER-HCM)

2x as Many Patients on CAMZYOS Increased Their Exercise Capacity (pVO2) and Saw Improvement or No Worsening in Symptoms (NYHA Classification) vs Placebo1

37% of patients saw improvement or no worsening symptoms on Camzyos

Patients achieving the primary composite endpoint at Week 301 | Difference (95% CI): 19% (9, 30); P=0.0005

Primary composite endpoint definition1,3

  • Exercise capacity was assessed with pVO2, an objective measure of peak oxygen consumption during CPET3,4*
  • Symptoms were assessed with NYHA class, a subjective measure of symptom burden1
  • The primary endpoint was defined as the proportion of patients who achieved either of the following changes from baseline to Week 303:
    • ≥1.5 mL/kg/min improvement in pVO2 AND ≥1 NYHA class improvement OR
    • ≥3.0 mL/kg/min improvement in pVO2 AND no worsening in NYHA class
* Type of exercise testing used in EXPLORER-HCM included either a treadmill or a bicycle.2

CI=confidence interval; CPET=cardiopulmonary exercise testing; NYHA=New York Heart Association; pVO2=peak oxygen consumption.

Exploratory Endpoint: CAMZYOS Reduced Valsalva LVOT Gradient at Week 30 With Results Sustained at ~3.5 Years2,4

Patients Achieved Reductions in Mean Provoked Valsalva LVOT Gradient by First Clinical Visit (Week 4)* That Were Sustained Through Week 304

Secondary endpoint: Mean change in postexercise LVOT peak gradient from baseline to Week 301
-47 mmHg mean change vs placebo (-10 mmHg) | Difference (95% Cl): -35 mmHg (-43, 28); P<0.0001

Exploratory endpoint: 57% of patients (n=64/113) on CAMZYOS had a postexercise LVOT gradient <30 mmHg 
vs 7% (n=8/114) on placebo at Week 304

The prespecified exploratory endpoints were not powered for significance, and statistical comparisons have not been made.

EXPLORER-HCM exploratory endpoint: Valsalva LVOT gradient from baseline to Week 301

  • The mean (SD) changes in Valsalva LVOT gradient were -49 (34) mmHg for the CAMZYOS group and -12 (31) mmHg for the placebo group

EXPLORER-LTE exploratory objective: Valsalva LVOT gradient from baseline to Week 1802

  • The mean (SD) change in Valsalva LVOT gradient was -55 (34) mmHg

Obstruction is defined as LVOT peak gradient ≥30 mmHg with or without provocation5

  • 91% of patients (n=81/89) who reached Week 180 no longer had obstruction2
  • Overall, 83% (n=191) achieved a reduced Valsalva LVOT gradient of 
≤30 mmHg, or below obstructive levels at the time of analysis (data cutoff)2
* Week 4 marks the first scheduled assessment of LVOT gradient following the initiation of CAMZYOS.1
† EXPLORER-LTE is a single-arm extension trial that does not include placebo.2

CI=confidence interval; HCM=hypertrophic cardiomyopathy; LVOT=left ventricular outflow tract; SD=standard deviation.

Impact to Cardiac Structure and Function at Week 30 Was Sustained at ~3.5 Years1,2,6,7

EXPLORER-HCM exploratory endpoint: Mean change in LVMI from baseline to Week 301,6

The mean (SD) change in LVMI was -7.4 (17.8) g/m2 for CAMZYOS and +8.9 (15.3) g/m2 in the placebo group.

EXPLORER-HCM exploratory endpoint: Mean change in LAVI from baseline to Week 301,6

The mean (SD) change in LAVI was -7.5 (7.8) mL/m2 for CAMZYOS and no change 
[-0.1 (8.7) mL/m2] in the placebo group.

EXPLORER-LTE exploratory endpoint: Mean change in LAVI from baseline to Week 1802,7

The mean (SD) change in LAVI was -5.5 (9.7) mL/m2 (n=62).

Prespecified exploratory endpoints were not powered for significance, and statistical comparisons have not been made.
The clinical significance of these findings is unknown.1
Echos provided by a US HCP.
HCP=healthcare provider; LAVI=left atrial volume index; LVOT=left ventricular outflow tract; LVMI=let ventricular mass index; SD=standard deviation.

CAMZYOS Improved NYHA Class at Week 30 With Results Sustained at ~3.5 Years1,2

These data were used to calculate the secondary endpoint related to NYHA class but were exploratory in nature and not evaluated for significance to compare between the treatment groups.4,8

At baseline, approximately 73% of patients were NYHA Class II and 27% were NYHA Class III.1

EXPLORER-HCM NYHA data4,9:

At Week 30, 42% (n=52) of patients taking CAMZYOS were Class II and 7% (n=8) were Class III vs 58% (n=74) and 20% (n=25) in the placebo arm, respectively.4,9

EXPLORER-LTE NYHA data2,10:

  • 37% (n=10/27) of patients who were NYHA Class III at baseline and reached Week 180 improved by 2 classes
  • 21% of patients experienced no change in NYHA class
  • One patient worsened from NYHA Class II to NYHA Class III at Week 180 and had ongoing atrial fibrillation unrelated to CAMZYOS during this time

Of the patients (n=95) at the Week 180 visit2:

63 (66%) were NYHA Class I
29 (31%) were NYHA Class II
3 (3%) were NYHA Class III

* Evaluation of symptoms via NYHA classification.4
† EXPLORER-LTE is a single-arm extension trial that does not include placebo.2
‡ Baseline is defined as last non-missing measurement before the first dose of CAMZYOS in MAVA-LTE.2

 BL=baseline; CI=confidence interval; NYHA=New York Heart Association.

Exploratory Endpoint: 80% Reduction in NT-proBNP at Week 30 With 
Results Sustained at ~3.5 Years1,2,4

NT-proBNP is a biomarker that can be used to measure cardiac stress. Elevated levels can be associated with negative outcomes in patients with symptomatic obstructive HCM2,4

Exploratory endpoint: Mean change in NT‑proBNP from baseline to 
Week 30 (EXPLORER‑HCM)1

Proportion of the geometric mean ratio between the groups was 0.20 (95% CI: 0.17, 0.24).

* EXPLORER-LTE is a single-arm extension trial that does not include placebo.2


Exploratory objective: Median change in NT‑proBNP from baseline to Week 180 (EXPLORER‑LTE)2

The median (IQR) change in NT-proBNP (n=88) was -562 (-1162.5, -209) ng/L.

Normalized NT-proBNP is defined as <124 ng/L2

At baseline in EXPLORER-LTE, 10% (n=22/230) of patients presented with an NT‑proBNP concentration of <124 ng/L, indicative of normal range. With continued CAMZYOS treatment, the proportion of patients with NT‑proBNP levels in the normal range increased to 28% at Week 4 (n=62/218) and 54% at Week 180 (n=50/93).

The prespecified exploratory endpoints were not powered for significance, and statistical comparisons have not been made.
The clinical significance of the NT-proBNP findings is unknown.1
HCM=hypertrophic cardiomyopathy; IQR=interquartile range; NT-proBNP=N-terminal pro–B-type natriuretic peptide; NYHA=New York Heart Association.

References:

  1. CAMZYOS [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2025.
  2. Garcia-Pavia P, Oreziak A, Masri A, et al. Long-term effect of mavacamten in obstructive hypertrophic cardiomyopathy. Eur Heart J. 2024;45(47):5071-5083.
  3. Ho CY, Olivotto I, Jacoby D, et al. Study design and rationale of EXPLORER-HCM: evaluation of mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy. Circ Heart Fail. 2020;13(6):e006853.
  4. Olivotto I, Oreziak A, Barriales-Villa R, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020;396(10253):759-769.
  5. Ommen SR, Ho CY, Asif IM, et al. 2024 AHA/ACC/AMSSM/HRS/PACES/SCMR Guideline for the Management of Hypertrophic Cardiomyopathy: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines. Circulation. 2024;149(23):e1239-e1311.
  6. Hegde SM, Lester SJ, Solomon SD, et al. Effect of mavacamten on echocardiographic features in symptomatic patients with obstructive hypertrophic cardiomyopathy. J Am Coll Cardiol. 2021;78(25):2518-2532.
  7. Garcia-Pavia P, Oręziak A, Masri A, et al. Long-term effect of mavacamten in obstructive hypertrophic cardiomyopathy. Eur Heart J. 2024;45(47):5071-5083 [supplementary appendix].
  8. Olivotto I, Oreziak A, Barriales-Villa R, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2020;396(10253):759-769 [supplementary appendix].
  9. Data on file. BMS-REF-MAVA-002. Princeton, NJ: Bristol-Myers Squibb Company; 2021.
  10. Data on file. BMS-REF-MAVA-0076. Princeton, NJ; Bristol-Myers Squibb Company; 2024.
References

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF HEART FAILURE

CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

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.

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:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

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.

CONTRAINDICATIONS

CAMZYOS is contraindicated with concomitant use of:

 
  • Strong CYP2C19 inhibitors
  • Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

WARNINGS AND PRECAUTIONS

Heart Failure
CAMZYOS reduces systolic contraction and can cause heart failure or significantly reduce ventricular function. Patients who experience a serious intercurrent illness (eg, serious infection) or arrhythmia (eg, atrial fibrillation or other uncontrolled tachyarrhythmia) are at greater risk of developing systolic dysfunction and heart failure.

Assess the patient’s 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.

Asymptomatic LVEF reduction, intercurrent illnesses, and arrhythmias require additional dosing considerations.

Initiation 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.

CYP450 Drug Interactions Leading to Heart Failure or Loss of Effectiveness

CAMZYOS 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.

Advise 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.

CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program

CAMZYOS 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:

 
  • Prescribers must be certified by enrolling in the REMS Program
  • Patients must enroll in the REMS Program and comply with ongoing monitoring requirements
  • Pharmacies must be certified by enrolling in the REMS Program and must only dispense to patients who are authorized to receive CAMZYOS
  • Wholesalers and distributors must only distribute to certified pharmacies

Further information is available at  www.CAMZYOSREMS.com  or by telephone at  1-833-628-7367.

Embryo-Fetal Toxicity

CAMZYOS 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. Combined hormonal contraceptives (CHCs) containing a combination of ethinyl estradiol and norethindrone may be used with CAMZYOS. However, CAMZYOS may reduce the effectiveness of certain other CHCs. 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.

ADVERSE REACTIONS

In 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.

Effects on Systolic Function

In 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.

DRUG INTERACTIONS

Potential for Other Drugs to Affect Plasma Concentrations of CAMZYOS

CAMZYOS 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.

Impact of Other Drugs on CAMZYOS:

 
  • Strong CYP2C19 Inhibitors: Concomitant use increases CAMZYOS exposure, which may increase the risk of heart failure due to systolic dysfunction. Concomitant use is contraindicated
  • Moderate to Strong CYP2C19 Inducers or Moderate to Strong CYP3A4 Inducers:  Concomitant use decreases CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. The risk of heart failure due to systolic dysfunction may increase with discontinuation of these inducers as the levels of induced enzyme normalizes. Concomitant use is contraindicated
  • Weak CYP2C19 Inhibitors or Moderate CYP3A4 Inhibitors: Concomitant use with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Initiate CAMZYOS at the recommended starting dose of 5 mg orally once daily in patients who are on stable therapy with a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS treatment and intend to initiate a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor. Schedule clinical and echocardiographic assessment 4 weeks after inhibitor initiation, and do not up-titrate CAMZYOS until 12 weeks after inhibitor initiation. Avoid initiation of concomitant weak CYP2C19 and moderate CYP3A4 inhibitors in patients who are on stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. For short-term use (eg, 1 week), interrupt CAMZYOS for the duration of treatment with a weak inhibitor of CYP2C19 or a moderate inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy
  • Moderate CYP2C19 Inhibitors or Strong CYP3A4 Inhibitors: Concomitant use with a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor increases CAMZYOS exposure, which may increase the risk of adverse drug reactions. Discontinuing use of a moderate CYP2C19 inhibitor or strong CYP3A4 inhibitor after long-term concomitant use may decrease CAMZYOS exposure, which may reduce CAMZYOS’ efficacy. Initiate CAMZYOS at a starting dosage of 2.5 mg orally once daily in patients who are on a stable therapy with a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Reduce dose of CAMZYOS by one level (ie, 15 to 10 mg, 10 to 5 mg, or 5 to 2.5 mg) in patients who are on CAMZYOS and intend to initiate a moderate CYP2C19 inhibitor or a strong CYP3A4 inhibitor. Avoid initiation of concomitant moderate CYP2C19 and strong CYP3A4 inhibitors in patients who are on a stable treatment with 2.5 mg of CAMZYOS because a lower dose is not available. An increase in dose of CAMZYOS may be needed if the moderate inhibitor of CYP2C19 or strong inhibitor of CYP3A4 is discontinued after long-term concomitant use. Monitor for new or worsening symptoms. For short-term use (ie, when CAMZYOS dose modification is not feasible), interrupt CAMZYOS for the duration of treatment with a moderate inhibitor of CYP2C19 or a strong inhibitor of CYP3A4. CAMZYOS may be reinitiated at the previous dose immediately on discontinuation of concomitant therapy

Potential for CAMZYOS to Affect Plasma Concentrations of Other Drugs

CAMZYOS is an inducer of CYP3A4, CYP2C9, and CYP2C19. Concomitant use with CYP3A4, CYP2C9, or CYP2C19 substrates may reduce plasma concentration of these drugs. Closely monitor when CAMZYOS is used with concomitant CYP3A4, CYP2C9, or CYP2C19 substrates unless otherwise recommended in the Prescribing Information.

Certain Combined Hormonal Contraceptives (CHCs): 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) or use an alternative contraceptive method that is not affected by CYP450 enzyme induction (eg, intrauterine system) during concomitant use and for 4 months after the last dose of CAMZYOS.

Drugs That Reduce Cardiac Contractility

Expect 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.

If 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.

SPECIFIC POPULATIONS

Pregnancy

CAMZYOS 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.

Lactation

The presence of CAMZYOS in human or animal milk, the drug’s 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’s clinical need for CAMZYOS and any potential adverse effects on the breastfed child from CAMZYOS or from the underlying maternal condition.

Females and Males of Reproductive Potential

Confirm 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 CHCs. If these CHCs are used, advise patients to add nonhormonal contraception (such as condoms) or use an alternative contraceptive method during concomitant use and for 4 months after the last dose of CAMZYOS.

INDICATION

CAMZYOS® (mavacamten) is 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.

Please see US  Full Prescribing Information, including  Boxed WARNING.

3500-US-2600154   05/26

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