Findings from COLLIGO-HCM reinforce Camzyos’ efficacy and safety profile in reducing left ventricular outflow tract (LVOT) obstruction and improving symptom burden in a racially diverse, global patient population
COLLIGO-HCM is a part of the WAYFARER-HCM global data program aimed at providing insights into use of Camzyos in real-world clinical practice
Bristol Myers Squibb (NYSE: BMY) today presented results from COLLIGO-HCM, a global retrospective real-world data study, in an oral session at the European Society of Cardiology(ESC) Congress 2025 in Madrid, Spain. The analysis showed that Camzyos (mavacamten) was associated with reductions in left ventricular outflow tract (LVOT) obstruction and improvements in symptom burden in a racially diverse population of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) treated in an international, real-world setting. The effectiveness and safety demonstrated in COLLIGO-HCM are consistent with results from randomized, controlled clinical trials and further support the growing body of evidence for Camzyos, the first and only approved cardiac myosin inhibitor, as a standard of care for New York Heart Association (NYHA) class II-III symptomatic oHCM.
“Obstructive HCM can lead to considerable negative impact on patients’ lives,” said Arnon Adler, MD, staff cardiologist at the Peter Munk Cardiac Centre at University Health Network and associate professor at the University of Toronto. “These global real-world outcomes data, which are consistent with results from clinical trials, reinforce the overall effectiveness and safety profile of Camzyos and its benefits for diverse global patient groups, including those that are often underrepresented in clinical trials.”
The COLLIGO-HCM study is part of Bristol Myers Squibb’s global real-world data program, WAYFARER-HCM (Worldwide AnalYsis on eFfectiveness AcRoss divErse populations for Real-world mavacamten use in patients with Hypertrophic CardioMyopathy), spanning seven countries (U.S., Canada, Germany, U.K., Netherlands, Australia, and Israel) and more than 3,000 patients.
“Real-world outcomes data have the potential to provide important insights from clinical practice that can help inform treatment decisions,” said Homa Dastani, vice president, Global HEOR Immunology and Cardiovascular, Bristol Myers Squibb. “These COLLIGO-HCM real-world effectiveness and safety data build on the well-established clinical program for Camzyos, which has consistently demonstrated reduction in obstruction and effective and lasting symptom improvement. Our clinical program and long-term extension analyses span nearly six years combined, and we look forward to continuing to demonstrate the long-term effectiveness and safety of Camzyos in real-world settings across diverse patient populations as part of our global WAYFARER-HCM program.”
The COLLIGO-HCM study assessed effectiveness and safety outcomes in a racially diverse population (n=278), including 23.2% Black, 5.4% Asian and 4.3% Middle Eastern or North African participants, who received treatment at sites across four continents. At baseline, 54.7% of patients were NYHA class II, and 45.3% were NYHA class III.
Results showed that 59.9% of patients achieved ≥1 NYHA class improvement by 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 an NYHA classification of II or below, including 30.9% (50/162) who had an NYHA classification of I; these proportions improved consistently through week 96. By week 36, almost all patients (90.3%) achieved mean LVOT gradients of ≤30 mm Hg at rest, and 76.8% after Valsalva provocation; these proportions remained consistent through week 96.
Some patients, 7.2% (20/278), initiated Camzyos as monotherapy. Of patients on background medication (e.g., beta blocker and/or calcium channel blocker) at baseline (n=258), 26.4% (68/258) discontinued at least one type of therapy, and 5% (13/258) down-titrated background medication after starting Camzyos.
Mean left ventricular ejection fraction (LVEF) following Camzyos initiation remained at or above 61% throughout follow-up; the baseline value was 66%. Temporary interruption of Camzyos due to LVEF ≤50% occurred in 11 patients (4%), and permanent discontinuation due to LVEF ≤50% occurred in three patients (1.1%). All patients’ LVEF returned to >50% after permanent discontinuation of Camzyos. Echocardiogram requirements to monitor LVEF are country dependent, including a Risk Evaluation and Mitigation Strategy (REMS) program in the U.S. The proportion of patients with LVEF ≤50% aligns with the published safety profile of Camzyos and was consistent across all sites, regardless of echocardiogram monitoring requirements.
New-onset atrial fibrillation was recorded in eight patients (2.9%), which is consistent with previously reported data from other real-world evidence studies as well as the pivotal oHCM clinical trials for Camzyos.
Camzyos is a standard of care for the treatment of NYHA class II-III symptomatic oHCM and is included in both the ESC and AHA/ACC clinical guidelines as a recommended option for when symptoms persist after first-line therapy.
