CAMZYOS® Gets Results
Mike, a patient living with symptomatic obstructive HCM, and his wife, Carla, were compensated for their time.
Individual results may vary.
First-in-Class* Treatment. Proven in Clinical Studies.
Helps improve symptoms† and the ability to be active‡
In a 30-week study, more people who took CAMZYOS were able to be more active compared with those who did not take it, and they saw their symptoms get better§ or stop getting worse.‖
Twice as many people taking CAMZYOS achieved this outcome (37%) compared with those taking placebo (17%).
*CAMZYOS is a cardiac myosin inhibitor.
†Symptoms were measured using the New York Heart Association, or NYHA, classification.
‡The ability to be active was determined by measuring peak oxygen consumption, or pVO2, which is the maximum amount of oxygen the body uses during exercise. This was measured during exercise testing on a bicycle or treadmill.
§Symptoms getting better or improving was defined as improvement in NYHA class.
‖In the CAMZYOS group at Week 30, 50% of patients were in NYHA Class 1, 42% were Class 2, and 7% Class 3. In the placebo group at Week 30, 21% of patients were in NYHA Class 1, 58% were Class 2, and 20% Class 3.
Reduced obstruction in the heart
CAMZYOS reduced obstruction in the heart 4X more vs those who did not take CAMZYOS at 30 weeks.
In a clinical study comparing CAMZYOS vs placebo, after 30 weeks, obstruction (measured by post-exercise LVOT gradient) decreased on average 47 mm Hg (started at 86 mm Hg and went down to 38) and for placebo decreased on average 10 mm Hg (started at 84 mm Hg and went down to 73).
In a different study (long-term, 180 weeks), there was a 79% average decrease in obstruction.
People who took CAMZYOS had an average decrease in LVOT gradient of 55 mm Hg at approximately 3.5 years; 91 people taking CAMZYOS had an average reduction in LVOT gradient from 70 mm Hg to 15 mm Hg at approximately 3.5 years.
This data is not included in the CAMZYOS U.S. Full Prescribing Information. There are limitations to the long-term study. See details below.
Why is this important?
In hearts with obstructive HCM, an obstruction can block oxygen-rich blood from being pumped throughout the body, which can lead to symptoms. CAMZYOS can help reduce the obstruction.
Most patients were symptom-free** at 3.5 years
2 out of 3 people had no symptoms or limitations with ordinary physical activity (defined as NYHA Class 1; 66%, 63/95) at 3.5 years.
2 studies illustrate symptom improvement:
Long-Term Study
About 3 out of 4 people†† taking CAMZYOS had improved symptoms at 3.5 years (78%). This study is in the process of tracking people for up to 5 years (252 weeks). The information included above was captured at 3.5 years. 74 out of 95 people on CAMZYOS experienced improved symptoms at 3.5 years. Additionally, 1 out of 3 people had mild symptoms and some exercise limitations – defined as NYHA Class 2. (This was 31% of people, or 29 out of 95.) Out of the 95 studied, the remaining 3 had noticeable symptoms with minimal physical activity (NYHA Class 3).
There are limitations to the long-term study. See more details below
How was this measured? Symptom improvement was defined as moving to a lower NYHA class in the study.
Primary Study
About 2 out of 3 people taking CAMZYOS had their symptoms improve at 30 weeks. 65% of people taking CAMZYOS improved by one or more NYHA class. (31% of people taking placebo did the same.) 80 out of 123 patients on CAMZYOS experienced improved symptoms, compared with 40 out of 128 patients on placebo, at 30 weeks.
**Symptom-free is defined as NYHA Class 1.
††95 patients to date (of 231) have reached Week 180 for evaluation.
Reduced eligibility for surgery
CAMZYOS reduced the number of patients who were eligible for surgery or who chose to undergo surgery at 16 weeks vs. those who did not take it.
4 out of 5 people (82%) who took CAMZYOS improved in their symptomatic oHCM and were no longer eligible for and did not proceed with surgery at 16 weeks, vs. 1 out of 5 people who took placebo.
About 1 out of 5 people taking CAMZYOS—18%, or 10/56—were still considered eligible for surgery at 16 weeks or had chosen to undergo surgery before Week 16. In contrast, 77% of patients on placebo (43/56) were still eligible for surgery at 16 weeks or decided to proceed with surgery. Two people in each group decided to have surgery.
CAMZYOS will not work for everyone. Individual results may vary. Your doctor will be able to advise you on whether CAMZYOS is right for you.
Learn more about the studies, including the side effects below.
STUDY 1
(Primary Study)
Who took part?
251 people with symptomatic oHCM—123 were treated with CAMZYOS and 128 with placebo for 30 weeks.
Though it wasn’t a requirement, most people (92%) remained on their previous medication, a beta-blocker or calcium channel blocker.
What did the study look at?
How well CAMZYOS was able to improve symptoms and the ability to be active.
Patients could achieve either less symptoms (improvement in NYHA Class) and improved pVO2 by at least 1.5 mL/kg/min OR symptoms remaining the same and improved pVO2 by at least 3.0 mL/kg/min.
STUDY 2
(Long-Term Study)
Who has taken part?
231 people continuing from Study 1. They all received CAMZYOS. Though it isn’t a requirement, most people (93%) have remained on their previous medication, a beta-blocker or calcium channel blocker.
When did Study 2 begin?
When Study 1 ended, people paused taking CAMZYOS for at least 8 weeks before starting Study 2.
How long will it last?
5 years, or 252 weeks. The results shown here were the results at 3.5 years, or 180 weeks, in 99 people who were evaluated.
What does the study look at?
First, to evaluate the safety of CAMZYOS, and then, understand the efficacy.
Important limitations to know
There are limitations to the long-term study. These data are not included in the CAMZYOS U.S. Full Prescribing Information. These data are based on real observations as part of an ongoing study. These data have not yet been tested to determine if results are based on real effect or random chance. All adults who participated knew they were taking CAMZYOS, which may have influenced the results.
STUDY 3
(Additional Study)
Who took part?
112 people with symptomatic oHCM; 56 were treated with CAMZYOS and 56 with placebo for 16 weeks.
When the study started, everyone had symptoms. Their oHCM was so advanced that they were all eligible for surgery. Most (93%) had severe symptoms (NYHA class 3 or 4). Most people (95%) were also taking additional treatments for oHCM, such as beta-blockers, calcium channel blockers, disopyramide, or a combination.
What did the study look at?
The study evaluated how many people remained eligible for, or who decided to proceed with surgery, prior to or at Week 16.
HCM=hypertrophic cardiomyopathy; LVOT=left ventricular outflow tract; mm Hg=millimeters of mercury.
Side Effects
If you and your doctor are considering CAMZYOS, it’s important to know the answers to these questions:
What are the serious side effects of CAMZYOS?
A serious side effect is a side effect that can sometimes be life-threatening and lead to death.
CAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force).
In the long-term study, 10 (4.3%) people in the study experienced drug-related serious adverse events, which included cardiac failure (3 people), ejection fraction decreased (5 people), atrial fibrillation (1 person), and atrial flutter (1 person).
Get medical help right away if you experience new or worsening symptoms, including:
- Shortness of breath
- Chest pain
- Fatigue
- Racing heart (palpitations)
- Leg swelling
- Rapid weight gain
What are the most common side effects?
The most common side effects of CAMZYOS include dizziness and fainting (syncope).
In the long-term study, 228 (98.7%) people experienced ≥1 drug-related adverse reaction. The most common drug-related adverse reaction occurring in >5% of people were COVID-19 infection (92 people), dizziness, (41 people), hypertension (36 people), and nasopharyngitis (36 people).
- Tell your healthcare provider if you have any side effect that bothers you or that does not go away
- These are not all of the possible side effects of CAMZYOS
- Talk to your healthcare provider for more information about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072
For more information, please see the U.S. Full Prescribing Information, including Boxed WARNING and Medication Guide for CAMZYOS. Talk to your healthcare provider for more information about this medication.