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Mavacamten Demonstrated Significant Reduction in Need for Septal Reduction Therapy in Symptomatic Obstructive HCM Patients in Phase 3 VALOR Trial

Published: 2022-04-02 13:30:00 ET
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Mavacamten is a first-in-class, investigational cardiac myosin inhibitor being developed by Bristol Myers Squibb

Study met all primary and secondary endpoints and patients receiving mavacamten demonstrated improvement in key cardiac measures after 16 weeks of treatment

VALOR-HCM study presented as late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 VALOR-HCM study, which showed the addition of mavacamten, an investigational, first-in-class cardiac myosin inhibitor, significantly reduced the need for septal reduction therapy (SRT) in patients with severely symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) who had been appropriate for SRT per the 2011 American College of Cardiology/American Heart Association (ACC/AHA) Guidelines at baseline. Study participants were on maximally tolerated background regimens when they entered the trial and remained on them through the duration of the study. These data were presented today as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session.

At 16 weeks the primary and all secondary endpoints were met. Of patients treated with mavacamten, 82% had not proceeded with SRT and no longer met the criteria for SRT according to the 2011 ACC/AHA Guidelines compared to 23% of patients receiving placebo. Patients in the mavacamten arm also demonstrated reduction in left ventricular outflow tract (LVOT) gradients, improvement in New York Heart Association (NYHA) Classification, improvement in quality-of-life measures and improvement in cardiac biomarkers at a high degree of statistical significance compared to the placebo arm. No new safety signals were observed.

“VALOR-HCM builds upon findings of the Phase 3 EXPLORER-HCM trial and shows mavacamten to be an effective potential treatment option for those with severe symptomatic obstructive HCM who meet guideline criteria for SRT,” said Milind Desai, M.D., MBA, director of HCM center and director of clinical operations, Heart, Vascular & Thoracic Institute, Cleveland Clinic. “The data presented today are clinically meaningful and have demonstrated the potential to impact parameters leading to SRT eligibility.”

Key findings at Week 16 included:

  • The composite percentage of patients who proceeded with SRT before or after Week 16 and those who remained eligible for SRT was significantly lower in those taking mavacamten than those receiving placebo (17.9% [10/56] vs 76.8% [43/56]; P