Bristol Myers Squibb (NYSE: BMY) has 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, the company said.
These data were presented today as a late-breaking clinical trial at the American College of Cardiology’s 71st Annual Scientific Session.
BMS explained that 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, the company said.
“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.”