Bristol Myers announces long-term follow-up data from Phase 3 studies of CAMZYOS

Bristol Myers Squibb announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS, a cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy. Results from the 56-week analysis of the VALOR-HCM long-term extension study were presented as a late-breaking oral presentation, with simultaneous publication in JAMA Cardiology, and results from the cumulative 120-week analysis of the EXPLORER cohort of the MAVA-LTE study were presented as an oral presentation at the European Society of Cardiology Congress 2023. Key findings from the 56-week analysis of VALOR-HCM LTE include: Treatment with CAMZYOS demonstrated sustained improvements across key study endpoints in both the original CAMZYOS group over 56 weeks and those transitioned to the placebo cross-over group over 40 weeks. At Week 56, 5 of 56 patients in the original CAMZYOS group and 10 of 52 patients in the placebo cross-over group at Week 40 decided to proceed with septal reduction therapy or were SRT-eligible. CAMZYOS demonstrated sustained reduction in peak resting LVOT gradient. Proportion with NYHA class improvement of greater than or equal to1 class was observed in 93% of patients in the original CAMZYOS group at Week 56 and 73% of patients from the placebo cross-over group at Week 40. On the patient-reported 23-item Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, average scores of symptom frequency, symptom burden and physical limitation continued to improve with a 14.1 point increase for the original CAMZYOS group and 11.7 point increase for the placebo crossover group. CAMZYOS was also associated with sustained reduction across biomarkers of cardiac wall stress and myocardial injury including reduction in N-terminal pro brain natriuretic peptide, with -376 ng/L for the original CAMZYOS group and -423 ng/L for the placebo cross-over group and reduction in cardiac troponin I with -7.0 ng/L for the original CAMZYOS group and -6.2 ng/L for the placebo cross-over group. No new safety signals were observed, and safety and efficacy were consistent across both patient groups. The KCCQ-23 CSS is derived from the Total Symptom Score and the Physical Limitations score of the KCCQ-23. The CSS ranges from 0 to 100 with higher scores representing better health status. Key findings from the cumulative 120-week analysis of EXPLORER-LTE include: No new safety signals were observed. Overall, 75.9% of patients improved by greater than or equal to1 NYHA class from baseline at the start of the LTE study to Week 120. Of the 14 patients who were in NYHA class I, 12 remained in NYHA class I at the latest available assessment. Treatment with CAMZYOS was associated with sustained improvements from baseline at the start of the LTE study in echocardiographic parameters, including E/e’ average and NT-proBNP. Mean LVEF remained within the normal range at all study visits. Since the previous interim analysis in August 2021, one new patient experienced a transient reduction in LVEF less than50% resulting in temporary treatment interruption.