Bristol Myers Squibb (BMS) has unveiled new long-term follow-up results from the EXPLORER-LTE cohort of the MAVA-long-term extension (LTE) clinical trial of CAMZYOS (mavacamten) in adults with New York Heart Association (NYHA) class II-III symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
The EXPLORER-LTE cohort is part of a five-year, dose-blinded study underway in patients who completed the EXPLORER-HCM trial.
Participants began with a daily 5mg dose of CAMZYOS, with dose adjustments at weeks four, eight, and 12 based on echocardiography measures of Valsalva resting left ventricular outflow tract (LVOT) gradient and LVEF.
The company noted that the latest findings underscore the sustained efficacy and safety of CAMZYOS, already established through prior research.
Patients showed consistent and sustained improvements in echocardiographic measures and biomarkers for up to 3.5 years, including resting LVOT gradient, Valsalva LVOT gradient, left atrial volume index, and NT-proBNP levels.
Symptom and functional capacity improvements were also noted, with most patients reaching NYHA class I.
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By GlobalDataCAMZYOS’s safety profile remained consistent over 3.5 years without any new safety concerns reported.
Of note, 20 patients experienced transient reductions in LVEF below 50%, but all recovered post-treatment interruption, with 14 resuming CAMZYOS therapy.
CAMZYOS is said to be the first cardiac myosin inhibitor approved in the US for adults with NYHA class II-III symptomatic oHCM.
Bristol Myers Squibb immunology, cardiovascular and neuroscience (ICN) development head and senior vice-president Roland Chen said: “These results, representing the longest duration of follow-up of the Phase III EXPLORER study to date, further reinforce the established safety and efficacy profile of CAMZYOS.
“As the first and only approved cardiac myosin inhibitor for patients with symptomatic obstructive HCM and with thousands of patients around the world treated to date, CAMZYOS, which targets the source of symptomatic obstructive HCM, is redefining the treatment landscape for this patient population.”
In June, the company reported findings from the Phase III CheckMate -9DW trial where Opdivo (nivolumab) plus Yervoy (ipilimumab) as a first-line treatment for unresectable hepatocellular carcinoma (HCC) improved overall survival (OS) rates.