COLLIGO-HCM Confirms Mavacamten’s Real-World Effectiveness in Obstructive HCM

Bristol Myers Squibb presents the results of COLLIGO-HCM, a global retrospective real-world data study, during an oral session at the European Society of Cardiology (ESC) 2025 Congress in Madrid, Spain.

Analysis has shown that Camzyos® (mavacamten) is associated with reductions in left ventricular outflow tract (LVOT) obstruction and improvements in symptom burden in an ethnically diverse population of patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) treated in a real-world international setting.

The efficacy and safety demonstrated in COLLIGO-HCM are consistent with results from randomized, controlled clinical trials

They support the growing body of evidence positioning mavacamten, the first and only cardiac myosin inhibitor approved to date, as the standard of care for patients with New York Heart Association (NYHA) functional class II-III obstructive HCM.

“Obstructive hypertrophic cardiomyopathy can have a negative impact on patients’ lives,” said Arnon Adler , a cardiologist at the Peter Munk Cardiac Centre at University Health Network and an associate professor at the University of Toronto. “These global real-world data, consistent with clinical trial results, reinforce the effectiveness and safety of mavacamten, as well as its benefits in diverse patient populations globally, who are often underrepresented in clinical trials,” he added.

The COLLIGO-HCM study is part of Bristol Myers Squibb’s global real-world data program, WAYFARER-HCM (Worldwide AnalYsis on eEffectiveness AcRoss divErse populations for Real-world mavacamten use in patients with Hypertrophic CardioMyopathy), which spans seven countries (USA, Canada, Germany, UK, Netherlands, Australia and Israel) and includes more than 3,000 patients.

The COLLIGO-HCM study evaluated effectiveness and safety outcomes in an ethnically diverse population

“Real-world data have the potential to provide important insights from clinical experience that can help guide therapeutic decisions,” said Homa Dastani , vice president of Global HEOR Immunology and Cardiovascular at Bristol Myers Squibb.

“These COLLIGO-HCM effectiveness and safety data, generated within the robust mavacamten clinical program, have consistently and sustainedly demonstrated reduced obstruction and improved symptoms. Our clinical program and long-term extension analyses span approximately six years, and we are confident in continuing to demonstrate the effectiveness and safety of mavacamten in real-world clinical settings across diverse populations through the global WAYFARER-HCM program.”

The COLLIGO-HCM study evaluated effectiveness and safety outcomes in an ethnically diverse population (n=278), including 23.2% Black patients, 5.4% Asian patients, and 4.3% Middle Eastern or North African patients, who received treatment at centers on four continents. At baseline, 54.7% of patients were in NYHA functional class II and 45.3% in class III.

The results of the COLLIGO-HCM study showed that 59.9% of patients achieved a ≥1 NYHA functional class improvement at week 24. Overall, 86.5% (180/208) of patients with at least 12 weeks of follow-up and 94.4% (153/162) of patients with at least 24 weeks of follow-up had NYHA class II or lower, including 30.9% (50/162) in class I. These percentages improved consistently through week 96. At week 36, 90.3% of patients achieved a mean LVOT gradient ≤30 mmHg at rest and 76.8% with the Valsalva maneuver; these figures remained stable through week 96.

7.2 % of patients (20/278) received mavacamten as monotherapy from the start of treatment. Among patients on background medications at baseline (n=258; e.g., beta-blockers and/or calcium channel blockers), 26.4% (68/258) discontinued at least one of those background medications, and 5% (13/258) reduced their background medication dose after starting mavacamten.

The COLLIGO-HCM study is part of Bristol Myers Squibb’s global real-world data program

The mean left ventricular ejection fraction (LVEF) remained at or above 61% throughout follow-up (baseline: 66%). Temporary drug interruptions were reported for LVEF ≤50% in 11 patients (4%) and permanent discontinuation for LVEF ≤50% in 3 patients (1.1%). All patients recovered an LVEF >50% after permanent drug discontinuation. Requirements for echocardiographic LVEF monitoring are country-specific, including a Risk Evaluation and Mitigation Management (REMS) program in the United States. The proportion of patients with LVEF ≤50% is consistent with the published safety profile of mavacamten and was consistent across centers, regardless of local echocardiographic monitoring requirements.

New-onset atrial fibrillation was recorded in eight patients (2.9%), in line with data previously reported in both real-life studies and pivotal clinical trials of the drug in symptomatic obstructive HCM.

Mavacamten is a standard of care for symptomatic obstructive HCM in NYHA functional class II-III and is listed in the ESC and AHA/ACC clinical practice guidelines as a recommended option when symptoms persist despite first-line therapy.

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