Trial Design
EXPLORER-HCM
A 30-week, phase 3 clinical trial for patients with NYHA Class II-III obstructive HCM (N=251).1
At baseline, 92% of patients were on background therapy
(BB or CCB).2
VALOR-HCM
A 16-week phase 3 clinical trial for patients with severely symptomatic obstructive HCM (N=112) who were eligible for SRT.1
At baseline,95% of patients were on background therapy (BB, CCB, disopyramide or combination therapy).3
EXPLORER-HCM and VALOR-HCM trials:
Significant benefit observed in both primary endpoints1
EXPLORER-HCM
2x as many patients taking CAMZYOS achieved the primary composite functional endpoint (symptoms and exercise capacity) vs. placebo: 37% with CAMZYOS (n=45/123) vs. 17% with placebo (n=22/128).
Treatment difference: 19% (95% CI: 8.67-30.13; p=0.0005)
VALOR-HCM
>3x as many patients were able to avoid SRT at 16 weeks (no longer guideline-eligible for SRT at Week 16 and did not choose to undergo SRT by Week 16*) with CAMZYOS vs. placebo: 18% (n=10/56) of patients taking CAMZYOS met the primary composite endpoints vs. 77% (n=43/56) taking placebo. Two patients in each group decided to proceed with SRT.
Treatment difference: 59% (95% CI: 44.0-73.9; p=0.0001)
BB=beta blocker; CCB=calcium channel blocker; HCM=hypertrophic cardiomyopathy; NYHA=New York Heart Association; SRT=septal reduction therapy
* Patient decision to proceed with SRT: CAMZYOS treatment group n=2 (4%), placebo group n=2 (4%). SRT status not evaluable (imputed as meeting guideline criteria): CAMZYOS treatment group n=0, placebo group n=2 (4%).
References: 1. CAMZYOS (mavacamten capsules) Product Monograph. Bristol Myers Squibb Canada, February 14, 2024. 2. Olivotto I, et al. Mavacamten for treatment of symptomatic obstructive hypertrophic cardiomyopathy (EXPLORER-HCM): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet 2020;396:759-69. 3. Desai MY, et al. Myosin inhibition in patients with obstructive hypertrophic cardiomyopathy referred for septal reduction therapy. J Am Coll Cardiol 2022;80(2):95-108.