Bristol Myers Squibb has announced that it will present data on CAMZYOS (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy at the American College of Cardiology (ACC) Annual Scientific Session & Expo, ACC.24, taking place April 6-8, 2024 in Atlanta, Georgia. Image courtesy: Getty Images
March 26, 2024 — Bristol Myers Squibb has announced that it will present data on CAMZYOS (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy at the American College of Cardiology/ACC Annual Scientific Session & Expo, ACC.24, taking place April 6-8, 2024 in Atlanta, Georgia.
According to a written statement issued ahead of ACC.24, Bristol Myers Squibb reported that analysis from a 10-month post-launch evaluation of the REMS Program finds 2.8% incidence of LVEF <50% in over 1500 patients, strengthening the safety profile of CAMZYOS (mavacamten) for NYHA class II-III obstructive hypertrophic cardiomyopathy. It added that real-world data reaffirmed the therapeutic value and treatment benefit of CAMZYOS in improving cardiac symptoms and NYHA class in patients with obstructive hypertrophic cardiomyopathy.
“The therapeutic benefit of CAMZYOS in real-world practice, demonstrated by our data at ACC, builds on the well-established clinical program and further underscores the importance of this transformational medicine which is the first and only approved cardiac myosin inhibitor,” said Roland Chen, MD, Senior Vice President and Head, Cardiovascular and Neuroscience Development, Global Drug Development for Bristol Myers Squibb. He added, “With thousands of patients around the world treated to date, CAMZYOS is redefining the treatment landscape for this patient population and may offer hope to countless others moving forward.”
Research to be presented at the meeting supports the robust safety and clinical profile of CAMZYOS (mavacamten) and compliance with the Risk Evaluation and Mitigation Strategy (REMS) Program, acording to the company. These data include:
- An analysis of results from the 10-month post-launch evaluation of the CAMZYOS REMS Program in 1,524 patients with patient status forms submitted, which demonstrated that approximately 1% (n=17) of patients reported clinical heart failure requiring hospitalization and 2.8% (n=43) of patients reported a decrease in left ventricular ejection fraction (LVEF) to <50%. These data are consistent with the clinical development program and reinforce the safety profile of CAMZYOS in clinical practice. These data (abstract 1075-07) will be featured as a moderated poster on Sunday, April 7 from 1:30 PM – 1:40 p.m. ET.
- A single-center real-world experience analysis of 53 patients treated with CAMZYOS which found that at 24 weeks, CAMZYOS led to improvements in cardiovascular symptoms (96%) and improvements in one or more New York Heart Association (NYHA) class (49%). Additionally, resting and Valsalva LVOT gradient decreased during the first four weeks after starting treatment, with statistically significant reductions from baseline at week 24 (P<0.001). No patients required cessation of treatment due to reduction of LVEF to <50% or other side effects, though two patients required temporary drug discontinuation due to Valsalva LVOT gradient less than 20 mmHg during the 24-week treatment period. These data (abstract 1424-134) will be featured as a poster on Sunday, April 7 from 1:15 PM – 2:00 p.m. ET.
CAMZYOS (mavacamten) is the first and only cardiac myosin inhibitor approved in the U.S., reports Bristol Myers Squibb, which further notes: CAMZYOS 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, and in the European Union, indicated for the treatment of symptomatic (NYHA, class II-III) obstructive HCM in adult patients. An allosteric and reversible inhibitor selective for cardiac myosin, CAMZYOS modulates the number of myosin heads that can enter “on actin” (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 HCM patients, myosin inhibition with CAMZYOS reduces dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.
More information: www.bms.com, acc.org
Related content:
Part 1: Hypertrophic Cardiomyopathy: One on One with a Cardiovascular Research Leader
Part 2: Hypertrophic Cardiomyopathy in Focus
“ONE ON ONE” WITH CHRISTINE SEIDMAN, MD, FACC, ON HYPERTROPHIC CARDIOMYOPATHY
Follow DAIC coverage of ACC.24 news here.
June 08, 2023 
