BMS builds case for cardiovascular drug mavacamten with new analysis

Bristol Myers Squibb has reported some new analysis for its investigational cardiovascular drug mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM).

The new analysis of data from the phase 3 EXPLORER-HCM study found a greater change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ OSS) at week 30 in mavacamten patients compared to placebo.

The 23-item KCCQ quantifies symptoms, physical function social function and quality of life for patients with cardiomyopathy.

“By using this tool, we were able to demonstrate substantial clinical benefits for patients taking mavacamten in the trial, which diminished when patients ended treatment,” commented John Spertus, lead study investigator.

In addition, more patients treated with mavacemten achieved a very large, clinically meaningful improvement in the KCCQ OSS compared to placebo – 35% versus 15%.

He added: “This new analysis of the EXPLORER-HCM data provides important insights into the benefits myosin inhibition can have in improving the health status of patients with severe obstructive hypertrophic cardiomyopathy, a chronic, often debilitating condition.”

In March, the US Food and Drug Administration (FDA) accepted mavacamten for review as a treatment for patients with symptomatic oHCM.

Hypertrophic cardiomyopathy (HCM) is a chronic and progressive disease which causes excessive contraction of the heart muscles and reduces the ability of the left ventricle to fill.

In both obstructive or non-obstructive HCM patients, physical exertion can cause fatigue or shortness of breath, and has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death.

BMS previously reported that, in the phase 3 EXPLORER-HCM trial, mavacamten met the primary endpoint of a composite functional score, designed to assess symptoms and cardiac function.

When compared to placebo, patients on mavacamten had greater reductions in post-exercise LVOT gradient as well as improved symptom scores.

BMS initially picked up mavacamten as part of its $13.1bn acquisition of MyoKardia, announced last year. This experimental candidate is a potentially first-in-class allosteric modulator of cardia myosin, believed to work by reducing cardiac muscle contractility.

“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,” said Jay Edelberg, head, heart failure and cardiomyopathy development at BMS.

“This new analysis of data from the phase 3 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,” he added.