공고 • Nov 11
Cytokinetics, Incorporated Presents Additional Data from MAPLE-HCM at Hypertrophic Cardiomyopathy Medical Society Scientific Sessions and American Heart Association Scientific Sessions 2025
Cytokinetics, Incorporated on November 10, 2025 announced that additional data from MAPLE-HCM (Metoprolol vs Aficamten in Patients with LVOT Obstruction on Exercise Capacity in HCM) were presented in three Late Breaking Science sessions at the Hypertrophic Cardiomyopathy Medical Society Scientific Sessions and the American Heart Association Scientific Sessions 2025 in New Orleans, LA. Two of the presentations were simultaneously published in the Journal of the American College of Cardiology. Responder Analysis Shows Significantly More Patients on Aficamten Achieved Positive or Complete Response Compared to Metoprolol. Andrew Wang, M.D., Cardiologist and Professor of Medicine, Duke University School of Medicine presented a pre-specified responder analysis from MAPLE-HCM evaluating five clinically relevant measures of disease burden: complete hemodynamic response, symptom improvement, cardiac biomarker response, enhanced exercise capacity and favorable cardiac remodeling. These results were also simultaneously published in the Journal of the American College of Cardiology. After 24 weeks of treatment, aficamten was associated with greater improvements than metoprolol in all outcome measures (all p<0.001). Additionally, the proportion of patients who had a positive response (improvement in three or four clinical parameters) or a complete response (improvement in all five clinical parameters) was 78% in those receiving aficamten vs. 3% for those receiving metoprolol (p<0.001). KCCQ, Kansas City Cardiomyopathy Questionnaire; LAVI, left atrial volume index; LVOT-G, left ventricular outflow tract gradient; NNT, number needed to treat; NT-proBNP, N-terminal pro–B-type natriuretic peptide; NYHA, New York Heart Association As previously disclosed, in MAPLE-HCM the rate of adverse events (AEs) was similar between groups. At least one treatment-emergent AE was reported by 65 (73.9%) and 66 (75.9%) patients treated with aficamten and metoprolol, respectively. The most common AE reported in the aficamten group in excess of the comparator (>5%) was hypertension (9 [10.2%] patients on aficamten compared to 2 [2.3%] patients on metoprolol) and the most common AE reported in the metoprolol group in excess of the comparator was dizziness (15 [17.2%] patients on metoprolol compared to 5 [5.7%] patients on aficamten). Analysis of Patient Reported Outcomes Expands on Effect of Aficamten on Patient Symptom Burden. Michael E. Nassif, M.D., Cardiologist, Saint Luke’s Mid America Heart Institute, Associate Professor of Medicine, University of Missouri Kansas City presented results from a pre-specified sub-study of two patient reported outcome instruments in MAPLE-HCM: the Kansas City Cardiomyopathy Questionnaire (KCCQ) and Seattle Angina Questionnaire Summary Score (SAQ). The results from this analysis were also simultaneously published in the Journal of the American College of Cardiology. At 24 weeks, treatment with aficamten resulted in significantly greater improvements than metoprolol in both KCCQ Overall Summary Score (KCCQ-OSS) (16.6 points vs. 8.9 points, respectively; between-group difference = 7.8 points [95% CI: 3.3 to 12.3; p=0.001]) and KCCQ Clinical Summary Score (KCCQ-CSS) (15.8 points vs. 8.7 points, respectively; between-group difference = 6.9 points [95% CI: 2.6 to 11.2; p=0.002]). Aficamten was also associated with statistically significant improvements across all KCCQ domains (p<0.05). Patients on aficamten more frequently reported very large improvements in KCCQ-OSS, defined as =20-point improvement (38.6% vs. 18.4%; number needed to treat (NNT)=4.9), and were significantly less likely to experience a worsening in KCCQ-OSS than those treated with metoprolol (6.8% vs 18.4%; number needed to harm (NNH)=8.6). A non-statistically significant trend for greater improvement in SAQ-SS was observed with aficamten (13.9 vs. 8.4 [adjusted between-group difference = 4.6 points; 95% CI: -0.3 to 9.5; p=0.063]), driven by a large and statistically significant improvement in the SAQ Physical Limitation Domain, where patients on aficamten improved by a mean of 18.7 points compared with 6.9 points for those on metoprolol (between-group difference = 10.1 points; 95% CI: 3.9 to 16.2; p=0.001). Changes in the SAQ Angina Frequency and Quality of Life Domains were similar between treatment groups. Aficamten Associated with Statistically Significant Improvement in Cardiac Biomarkers Compared to Metoprolol. Neal K. Lakdawala, M.D., Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School presented a pre-specified supplemental analysis from MAPLE-HCM of the impact of treatment with aficamten compared to metoprolol on the cardiac biomarkers NT-proBNP and high sensitivity cardiac troponin I (hs-cTnI). At baseline, high NT-proBNP and high hs-cTnI, indicative of cardiac wall stress and myocardial injury, respectively, were strongly correlated and generally associated with worse diastolic dysfunction. After treatment for 24 weeks, aficamten was associated with a 73% reduction (p<0.001) from baseline in NT-proBNP compared to an increase of 42% observed in patients receiving metoprolol (-81% treatment effect, p<0.001). Similarly, aficamten was associated with a 43% reduction in hs-cTnI, compared to a 17% decrease for metoprolol (-28% treatment effect, p=0.001). Patients with the greatest reductions in NT-proBNP experienced greater improvements in peak oxygen uptake (pVO2) and ventilatory efficiency (VE/VCO2). Additionally, changes in NT-proBNP were correlated with reductions of left ventricular outflow tract gradients (LVOT-G) and improved health status (KCCQ-OSS).