Key Takeaways:
- Data from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study confirms the sustained efficacy and safety of CAMZYOS in treating symptomatic obstructive hypertrophic cardiomyopathy (oHCM) over a period of up to 3.5 years.
- CAMZYOS is recognized as a standard of care for oHCM, being the first and only cardiac myosin inhibitor approved, with its inclusion in both ESC and AHA/ACC clinical guidelines.
- The long-term follow-up of patients on CAMZYOS revealed no new safety concerns, reinforcing its established safety profile in the treatment of oHCM.
Bristol Myers Squibb (NYSE: BMY) has unveiled new long-term data from the EXPLORER-LTE cohort of the MAVA-Long-Term Extension (LTE) study, assessing the efficacy and safety of CAMZYOS® (mavacamten) in patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Presented at the European Society of Cardiology (ESC) Congress in London, the findings underscore CAMZYOS’s consistent benefits over an extended treatment period of up to 3.5 years, further solidifying its role as a standard of care in this patient population.
The EXPLORER-LTE data demonstrated that patients treated with CAMZYOS experienced consistent and sustained improvements in multiple echocardiographic measures and biomarkers, including reductions in left ventricular outflow tract (LVOT) gradient, left atrial volume index, and N-terminal pro B-type natriuretic peptide (NT-proBNP) levels. These improvements were accompanied by enhanced symptoms and functional capacity, with the majority of patients achieving New York Heart Association (NYHA) class I status by Week 180 of the study.
At the data cutoff, 211 of the 231 patients enrolled in MAVA-LTE were receiving CAMZYOS, with 185 and 99 patients having reached Week 156 and 180, respectively. The data revealed that patients experienced a reduction of 55.3 mmHg in Valsalva LVOT gradient and a decrease of over 500 ng/L in NT-proBNP levels by Week 180. Importantly, the safety profile of CAMZYOS remained consistent, with no new safety signals identified throughout the follow-up period.
Recognition in Clinical Guidelines in Managing oHCM
CAMZYOS, the first and only approved cardiac myosin inhibitor targeting the underlying cause of symptomatic oHCM, has been incorporated into both the ESC and AHA/ACC clinical guidelines as a recommended treatment option. Its recognition as a standard of care underscores the significance of this therapy in managing oHCM, a chronic condition that requires ongoing treatment to mitigate symptoms and improve patient outcomes.
Dr. Pablo García-Pavia, a leading cardiologist and professor at the Spanish Cardiovascular Research Institute (CNIC), emphasized the importance of these long-term findings: “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.”
No New Safety Signals Observed
The long-term safety data from the EXPLORER-LTE study corroborated the well-established safety profile of CAMZYOS. Out of the 211 patients on CAMZYOS, 20 experienced transient reductions in left ventricular ejection fraction (LVEF) below 50%, all of whom recovered following treatment interruption. Notably, 14 of these patients were able to reinitiate treatment with CAMZYOS, further demonstrating the manageable nature of these events under clinical supervision.
Dr. Roland Chen, Senior Vice President and Head of Immunology, Cardiovascular & Neuroscience (ICN) Development at Bristol Myers Squibb, commented on the findings: “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. This therapy is redefining the treatment landscape for patients with symptomatic obstructive HCM.”
The long-term follow-up data from the EXPLORER-LTE study provides compelling evidence of CAMZYOS’s sustained efficacy and safety in treating symptomatic oHCM. As the first and only cardiac myosin inhibitor approved for this condition, CAMZYOS continues to play a pivotal role in improving the lives of patients with oHCM, with its status as a standard of care now firmly established.
Resource: Bristol Myers Squibb, September 01, 2024
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