VALOR-HCM phase III trial of MYK 461 meets primary endpoint in symptomatic obstructive hypertrophic cardiomyopathy.
Bristol Myers Squibb announced that VALOR-HCM, the Phase III randomized, double-blind, placebo-controlled study evaluating MYK 461 (mavacamten) in adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who are eligible for septal reduction therapy (SRT), met its primary endpoint at Week 16.
The safety of mavacamten was consistent with previous studies.
VALOR-HCM (NCT04349072) is a randomized, double-blind, placebo-controlled, multicenter Phase III study of patients with symptomatic, obstructive HCM (NYHA class III-IV) who meet guideline criteria for septal reduction therapy (SRT) and have been referred for an invasive procedure. The study enrolled over 100 patients randomized on a 1:1 basis to receive mavacamten or placebo. VALOR-HCM includes three treatment periods over 128 weeks: a 16-week placebo-controlled period, a 16-week active treatment period where all patients will receive mavacamten and a 96-week long-term extension period where all patients will continue to receive mavacamten.
The primary endpoint of VALOR-HCM is a composite of the number of patients who decide to proceed with SRT prior to or at Week 16 and the number of patients who remain SRT-guideline eligible (LVOT gradient of at least 50mmHg and NYHA Class III-IV) at Week 16 in the mavacamten group compared with the placebo group. Key secondary endpoints include impact on exercise gradient LVOT, NYHA Class and Kansas City Cardiomyopathy Questionnaire (KCCQ) and biomarkers at Week 16. The company plans to share these data with regulatory authorities.
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