BMS reports positive results in Phase III SCOUT-HCM trial for oHCM

Bristol Myers Squibb (BMS) has announced positive top line results from the Phase III SCOUT-HCM trial assessing Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

This is the first study of a cardiac myosin inhibitor (CMI) in adolescents aged 12 to under 18 years with symptomatic oHCM, said BMS.

The placebo-controlled, randomised, double-blind international trial achieved its primary endpoint, showing a statistically significant reduction from baseline in Valsalva left ventricular outflow tract (LVOT) gradient at week 28 compared to placebo, indicating improved LVOT obstruction.

It also met statistical significance for multiple secondary endpoints related to other clinically relevant aspects of the disease. Safety data were consistent with the established profile of Camzyos in adults, and no new safety signals emerged for this younger population. The study is ongoing, with active treatment and long-term extension phases continuing.

BMS plans to work with investigators to present comprehensive results at a forthcoming medical congress and engage with health authorities regarding the findings.

Camzyos is supported by extensive global clinical trials and real-world evidence within its class, demonstrating its effect on reducing hypercontractility by inhibiting excess myosin-actin cross-bridges in the sarcomere.

The SCOUT-HCM trial enrolled 44 participants with symptomatic oHCM. The design included a 28-week placebo-controlled period, followed by a 28-week active treatment crossover phase, and an open-label extension up to 144 weeks.

Primary endpoint measured change in Valsalva LVOT gradient; secondary endpoints included peak oxygen consumption, resting and post-exercise LVOT gradients, health status, symptoms, pharmacokinetic parameters, and safety.

BMS executive vice-president, chief medical officer and development head Cristian Massacesi said: “Adolescent oHCM is a serious, rare disease associated with substantial morbidity and mortality. The SCOUT-HCM top line results highlight the potential for Camzyos to be the first cardiac myosin inhibitor for adolescent patients with oHCM.

“Camzyos has redefined the treatment paradigm for symptomatic oHCM in adults, with over 20,000 patients started in the US alone, and we look forward to the potential opportunity to transform clinical care in the adolescent patient population.”

Children’s Hospital of Philadelphia site principal investigator Joseph Rossano served as a paid consultant to BMS for the SCOUT-HCM study.

In September 2024, BMS announced long-term follow-up findings from the EXPLORER-LTE cohort of the MAVA-long-term extension clinical trial of Camzyos in adults with New York Heart Association class II–III symptomatic oHCM.

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