Myosin inhibitors(Jiangsu Hengrui Pharmaceuticals)

Bristol Myers Squibb announced new long-term follow-up results for its cardiac myosin inhibitor Camzyos (mavacamten) in patients with obstructive hypertrophic cardiomyopathy (oHCM), demonstrating sustained improvements in echocardiographic measures, biomarkers and symptoms for up to 3.5 years.Long-term results from the EXPLORER cohort of the MAVA-LTE study, which were presented Sunday at the European Society of Cardiology (ESC) Congress, come as potential competition from Cytokinetics looms on the horizon.Camzyos won FDA approval in 2022 to improve functional capacity and symptoms in adults with symptomatic NYHA class II-III oHCM based on data from the Phase III EXPLORER-HCM trial. At 30 weeks, the study found that 37% of Camzyos-treated patients achieved the primary composite endpoint, consisting of either a noticeable improvement in the patient's ability to exercise plus at least one NYHA class reduction, or a significant increase in exercise ability without their condition getting worse. In the placebo arm, only 17% had achieved the study's main goal.Stable heart metricsThe new data from MAVA-LTE build on those findings. The cumulative analysis of up to 3.5 years of treatment reveals sustained improvements in echocardiographic measures, including resting and Valsalva left ventricular outflow tract (LVOT) gradients. The study also found consistent reductions in left atrial volume index and NT-proBNP levels, as well as continued improvement in symptoms and functional capacity.Specifically, 66.3% of patients improved to NYHA class I at week 180, indicating a significant symptom benefit. Further, researchers noted that while the mean left ventricular ejection fraction (LVEF) dropped by 11% from the start of the study to week 180, the average LVEF value over that time (63.9%) was still within the normal range.Researchers noted that LVEF reductions of < 50% were seen in 20 patients (8.7%) during long-term therapy, but these cases were "transient and reversible." Overall, 14.3% of patients experienced atrial fibrillation, 6.1% experienced cardiac failure episodes, and 5.6% permanently discontinued treatment due to adverse events.Rival filingsCytokinetics earlier this year presented detailed results from the Phase III SEQUOIA-HCM trial for its investigational cardiomyopathy drug aficamten. The trial showed that the cardiac myosin inhibitor significantly improved exercise capacity and achieved statistical significance on all 10 secondary endpoints, reflecting benefits in symptoms and function as early as two weeks after the first doseThe company, which has said it plans to submit an FDA filing this quarter and an application in the EU towards year-end, is positioning aficamten as a potentially safer alternative to Camzyos, emphasising that no instances of worsening heart failure or treatment interruptions due to low LVEF were observed in the SEQUOIA-HCM trial.A recent FirstWord poll of US cardiologists, conducted shortly after the SEQUOIA-HCM data release, shed light on the competitive landscape, with more than 60% of respondents saying they would be influenced to prescribe aficamten if it comes with less restrictive REMS requirements. However, a narrow majority of physicians said they would still opt for Camzyos over aficamten, possibly due to familiarity with the first-to-market drug.For more, check out FirstWord's interview with Narinder (Nani) Bhalla, senior vice president, worldwide medical, and head of cardiovascular & established brands at BMS, who shared his thoughts on the latest results in ViewPoints: ESC presentation of long-term data on Camzyos throws pre-emptive 'one-two punch' at would-be contender.