Bristol Myers Squibb (BMS) has reported the latest interim data from the EXPLORER-LTE cohort of the MAVA-LTE study, where mavacamten showed improved cardiovascular outcomes in symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM) patients.
An oral investigational therapy, mavacamten is an inhibitor of cardiac myosin.
MAVA-LTE is a dose-blinded, five-year study analysing mavacamten in symptomatic obstructive HCM patients who took part in Phase III EXPLORER-HCM trial.
The EXPLORER-LTE cohort enrolled 231 of the 244 subjects who were qualified to be part of the long-term extension study at the end of EXPLORER-HCM.
Findings showed that the mavacamten treatment offered clinically meaningful, sustained improvements in left ventricular outflow tract (LVOT) gradients, N-terminal pro brain natriuretic peptide (NT-proBNP) levels and New York Heart Association (NYHA) Class at 48 weeks and up to 84 weeks.
Furthermore, the safety profile of the oral therapy was in line with the EXPLORER-HCM trial.
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In the long-term follow-up period, no new safety signals were reported with the exposure adjusted event rates found to be stable or reduced in the cohort.
Bristol Myers Squibb vice-president and mavacamten development programme lead Marie-Laure Papi said: “Interim results from this EXPLORER-LTE cohort build upon the clinical evidence supporting the potential for longer-term use of mavacamten in patients with symptomatic obstructive HCM.
“We look forward to the opportunity to bring this medicine to patients and eagerly await the US Food and Drug Administration’s decision on our New Drug Application later this month.”
According to data from clinical and preclinical studies, mavacamten was found to consistently lower cardiac wall stress biomarkers, reduced excessive cardiac contractility, boosted diastolic compliance and lowered LVOT gradients.
In December last year, BMS reported interim data from the Phase III TRANSFORM trial of Breyanzi (lisocabtagene maraleucel; liso-cel), which boosted outcomes in adult relapsed or refractory large B-cell lymphoma patients.