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EXPLORER-LTE: An ongoing extension of the Phase 3 EXPLORER-HCM trial to evaluate the long-term efficacy and safety of CAMZYOS1

EXPLORER-LTE is an open-label, single-arm, ongoing extension of the Phase 3 EXPLORER-HCM trial designed to evaluate the long-term efficacy and safety of CAMZYOS. 231 out of the 244 (95%) patients who completed the EXPLORER-HCM trial, including the 8-week washout period, were enrolled into the EXPLORER-LTE cohort of the MAVA-LTE study. At data cutoff (31 August 2023), 211 (91%) still received CAMZYOS.1

EXPLORER-LTE study design*†1

Mean time from EXPLORER-HCM end-of-study visit (Week 38) to Day 1 of EXPLORER-LTE was 66.5 days (IQR: 3–359)1

Treatment difference, 53.5%; 95% CI: 42 to 65

Adapted from Garcia-Pavia P et al. 2024.1
*The data cutoff date for this interim analysis was 31 August 2023.1
Patients were assessed at 12-week intervals until Week 156, followed by assessments at 24-week intervals.1
Dose adjustments were made based on evaluation of LVOT gradient with the Valsalva manoeuvre and LVEF using site-read echocardiogram readings (echocardiograms were also sent to the central laboratory for review).1
§
A site-read stress echocardiogram was also performed at Week 24 to evaluate the post-exercise LVOT gradient; a dose increase was allowed per the investigator’s request if the post-exercise LVOT gradient was ≥50 mmHg.2

EXPLORER-LTE: Baseline demographics and disease characteristics1

EXPLORER-LTE baseline characteristics1

EXPLORER-LTE baseline characteristics table

Adapted from Garcia-Pavia P et al. 2024.1
*Beta blocker use at baseline derived from concomitant medication data in MAVA-LTE.1
Calcium channel blocker use was limited to diltiazem and verapamil.1

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Please refer to the CAMZYOS Summary of Product Characteristics for further information on dosing, initiation and safety.

BB, beta blocker; BMI, body mass index; CCB, calcium channel blocker; HCM, hypertrophic cardiomyopathy; IQR, interquartile range; LTE, long-term extension; LVEF, left ventricular ejection fraction; LVOT, left ventricular outflow tract; NT-proBNP, N-terminal pro-B-type natriuretic peptide; NYHA, New York Heart Association; QD, once daily; SD, standard deviation; TTE, transthoracic echocardiogram.

References
  1. Garcia-Pavia P et al. Eur Heart J. 2024. ehae579.
  2. Rader F et al. JACC Heart Fail. 2024;12(1):164–177.

3500-GB-2400195  |  November 2024