Bristol Myers Squibb announced positive topline results from SCOUT-HCM, a Phase 3 trial evaluating Camzyos (mavacamten) in the first study of a cardiac myosin inhibitor (CMI) in adolescents (ages 12 years to <18 years) with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). The trial met its primary endpoint, demonstrating a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at Week 28 versus placebo, indicating Camzyos was effective in improving LVOT obstruction. Statistical significance was also met for multiple secondary endpoints, including those for clinically meaningful aspects of the disease.
Safety results in the trial were consistent with the established safety profile of Camzyos in adults, and no new safety signals were reported in this new, younger population. The study continues with active treatment and long-term extension periods. "Adolescent oHCM is a serious, rare disease associated with substantial morbidity and mortality.
"Adolescent oHC M is a serious, rare diseaseassociated with substantial morbidity and mortality". Bristol Myers Squibb will work with key investigators to present detailed results at an upcoming medical congress, as well as discuss these data with health authorities. Camzyos is supported by the largest global clinical trial and real-world evidence base in the CMI class, reinforcing its role in transforming care for symptomatic oHCM in adults by reducing hypercontractility through inhibition of excess myosin-actin cross-bridges in the sarcomere.
Bristol Myers Squibb thanks the patients and their caregivers, investigators, and trial sites who participated in this clinical trial. About the Phase 3 SCOUT-HCM Trial SCOUT-HCM (NCT06253221) is a Phase 3 randomized, double-blind, placebo-controlled international trial that enrolled 44 adolescent patients (12 years to <18 years old) with symptomatic oHCM. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 impucers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is chronic with the following: Strong CYP2C19 inhibitors; moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers.
Because of the risk of heart failure Due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS Program. CAMZYOS is only available through a restricted program called the CAMZYOS RemS Program because of the risk of heart failure due of systolic dysfunction. These risks, assumptions, uncertainties and other factors include, among others, that future study results may not be consistent with the results to the results to improve LVOT obstruction.
