Bristol Myers Squibb (BMS) has reported that new analysis of data from the Phase III EXPLORER-HCM study showed health status improvement with mavacamten in obstructive hypertrophic cardiomyopathy (oHCM) patients.
An allosteric inhibitor of cardiac myosin, mavacamten is being analysed for treating diseases caused by increased cardiac contractility and reduced diastolic filling of the heart.
It works by lowering cardiac muscle contractility by hindering the formation of excessive myosin-actin cross-bridge that causes hypercontractility, left ventricular hypertrophy, and low compliance.
The double-blind, placebo-controlled Phase III trial enrolled 251 symptomatic oHCM patients who randomly received mavacamten or placebo for 30 weeks, and included a subsequent eight-week washout period.
A composite functional analysis to assess mavacamten’s effect on symptoms and function formed the trial’s primary goal.
At 30 weeks, 92 subjects in the mavacamten arm and 88 in the placebo arm completed the Kansas City Cardiomyopathy Questionnaire (KCCQ), a 23-item disease-specific questionnaire measuring symptoms, physical function, social function and quality of life.
Data showed that the change in KCCQ Overall Summary Score (KCCQ OSS) at 30 weeks, was higher in mavacamten arm over placebo, with a similar trend observed in all KCCQ subscales.
Furthermore, more subjects in the mavacamten arm had a high, clinically meaningful improvement of 36% in the KCCQ OSS, versus 15% in the placebo arm.
At week 30, a higher number of subjects in the placebo group showed no change or decline in their health status.
Bristol Myers Squibb Heart Failure and Cardiomyopathy Development head Jay Edelberg said: “Mavacamten represents Bristol Myers Squibb’s ongoing dedication to improving the lives of patients, especially those living with chronic cardiovascular diseases such as oHCM, through scientific discovery.
“This new analysis of data from the Phase III EXPLORER-HCM trial further supports the scientific evidence suggesting the benefit mavacamten can have on improving health status, symptoms and quality of life in patients with symptomatic oHCM and we look forward to potentially bringing this important new therapy to patients next year.”
In March this year, BMS reported primary results from the Phase II/III trial of a fixed-dose combination of relatlimab and Opdivo in patients with previously untreated metastatic or unresectable melanoma.