Primary endpoint
VALOR-HCM: CAMZYOS (mavacamten) significantly reduced guideline eligibility for invasive septal reduction therapy vs placebo at Week 16, sustained through to Week 561–3
Adapted from Desai MY et al. 2022.2
*Background therapies included beta blockers, calcium channel blockers, and disopyramide. Only 5.4% (3/56) of patients on each treatment arm did not receive any background medication due to intolerance.2,3
The primary endpoint was a composite of patient decision to proceed with SRT prior to or at Week 16 or patients who remain SRT eligible (defined as a LVOT gradient of ≥50 mmHg and NYHA class III-IV, or class II with exertional syncope or near syncope) at Week 161
82%
(46/56) of patients treated with CAMZYOS were guideline ineligible for SRT or decided not to proceed with SRT at Week 16 vs 23% (13/56) of patients on placebo1,2
~4x
fewer patients met guideline criteria for SRT or chose to undergo SRT with CAMZYOS vs placebo at Week 161
CAMZYOS continued to reduce guideline eligibility for invasive SRT at Week 56, including in patients who crossed over from placebo at Week 16*3
Adapted from Desai MY et al. 2023.3
*The average exposure duration to CAMZYOS at Week 56 for patients who crossed over from placebo at Week 16 was 40 weeks.3
†Background therapies included beta blockers, calcium channel blockers, and disopyramide. Only 5.4% (3/56) of patients on each treatment arm did not receive any background medication due to intolerance.3
‡A total of 4 patients randomly assigned to placebo were excluded from further analysis after the double-blind period (Week 0–16). Two patients decided to proceed with SRT, 1 patient withdrew consent, and 1 patient was found ineligible before the Week 16 visit.3
See the safety profile
Please refer to the CAMZYOS Summary of Product Characteristics for further information on dosing, initiation and safety.
CI, confidence interval; LVOT, left ventricular outflow tract; NYHA, New York Heart Association; SoC, standard of care; SRT, septal reduction therapy.
References
- CAMZYOS (mavacamten) Summary of Product Characteristics.
- Desai MY et al. J Am Coll Cardiol. 2022;80(2):95–108.
- Desai MY et al. JAMA Cardiol. 2023;8(10):968–977.
3500-GB-2400412 | November 2024