Camzyos Demonstrates Efficacy, Safety Treating Symptomatic Obstructive Hypertrophic Cardiomyopathy

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Long-term follow-up data from Bristol Myers Squibb’s (BMS) Phase III EXPLORER-LTE study demonstrated sustained efficacy and safety over 3.5 years of continuous treatment with Camzyos (mavacamten) in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Based on inclusion in both European Society of Cardiology (ESC) and AHA/ACC clinical guidelines, Camzyos is a recommended option to address symptoms that persist after first-line therapy, according to BMS.¹

“The consistent and sustained improvements in multiple cardiac measures over more than three years with Camzyos shows that this therapy meets an important treatment need for patients with symptomatic obstructive HCM,” said Pablo García-Pavia, MD, PhD, head, Inherited Cardiac Diseases and Heart Failure Unit, Department of Cardiology of Hospital Universitario Puerta de Hierro, professor, Spanish Cardiovascular Research Institute, in a press release. “These positive long-term data, together with the inclusion of Camzyos in ESC clinical guidelines for obstructive HCM, underscore the important role of this medicine in the long-term care of this lifelong condition that requires ongoing management.”

The analysis included findings from the double-blind, randomized, placebo-controlled, parallel group EXPLORER-LTE trial and a cohort of the MAVA-LTE study, which is an ongoing, dose-blinded, five-year study of Camzyos in patients with symptomatic oHCM who completed the EXPLORER-HCM trial. The trial, which enrolled 251 patients, only included individuals with measurable left ventricular ejection fraction (LVEF) ≥55% and at least one peak left ventricular outflow tract (LVOT) gradient ≥50 mmHg. All patients began with 5 mg, with dose adjustments made every four weeks based on site-read echocardiography measures of Valsalva LVOT gradient and LVEF. The primary endpoint of the study was a composite functional endpoint assessed at 30 weeks, with secondary endpoints including impact on exercise gradient LVOT, pVO 2, New York Heart Association (NYHA) Functional Classification for Heart Failure class and Kansas City Cardiomyopathy Questionnaire and Hypertrophic Cardiomyopathy Symptom Questionnaire at week 30.

Results found that a majority of patients achieved improved NYHA functional class, with over 66% reaching NYHA class I. Additionally, data showed a sustained improvement from baseline to weeks 156 and 180 in echocardiographic measures and biomarkers. A total of 211 of 231 patients who enrolled in MAVA-LTE reached weeks 156 and 180 at the time of data cutoff. Mean LVEF decreased by 11% from baseline to week 180, and the mean (63.9%) remained within normal range.

Adverse events (AEs) occurred in less than 5% of study participants, with common AEs that included dizziness and syncope. In VALOR-HCM, no new AEs were identified. BMS warns that use of a weak CYP2C19 inhibitor or a moderate CYP3A4 inhibitor increases the risk of an AE with Camzyos. Further, the developmental and health benefits of breastfeeding should be considered before taking Camzyos. No new safety signals were identified in patients treated with Camzyos.¹

“These results, representing the longest duration of follow up of the Phase 3 EXPLORER study to date, further reinforce the established safety and efficacy profile of Camzyos,” said Roland Chen, MD, SVP, head of Immunology, Cardiovascular & Neuroscience Development, BMS, in the press release. “As the first and only approved cardiac myosin inhibitor for patients with symptomatic obstructive HCM and with thousands of patients around the world treated to date, CAMZYOS, which targets the source of symptomatic obstructive HCM, is redefining the treatment landscape for this patient population.”

References

1. Long-Term Follow-Up Data from Phase 3 Study of CAMZYOS® (mavacamten) Underscores Established Efficacy and Safety Profile in Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM). BMS. September 1, 2024. Accessed September 3, 2024. https://news.bms.com/news/details/2024/Long-Term-Follow-Up-Data-from-Phase-3-Study-of-CAMZYOS-mavacamten-Underscores-Established-Efficacy-and-Safety-Profile-in-Patients-with-Symptomatic-Obstructive-Hypertrophic-Cardiomyopathy-oHCM/default.aspx