CAMZYOS Select
Safety Profile in
the
EXPLORER-
HCM
Study1

EXPLORER-HCM
Adverse reactions occurring in >5% of patients and more
commonly on CAMZYOS than on placebo*

  CAMZYOS (n=123) Placebo (n=128)
Dizziness, % 27 18
Syncope, % 6 2
  • *Adverse reactions are defined as responses that are unintended, occurring at doses typically used to treat a disease.2

Effects on systolic function1

  • Mean (SD) resting LVEF was 74% (6) at baseline in both treatment groups
  • Mean (SD) absolute change from baseline in LVEF was -4% (8) in the CAMZYOS group and 0% (7) in the placebo group over the 30-week treatment period
  • At week 38, following an 8-week interruption of trial drug, mean LVEF was similar to baseline for both treatment groups
  • 7 (6%) patients in the CAMZYOS group and 2 (2%) patients in the placebo group experienced reversible reductions in LVEF <50% (median 48%: range 35%-49%) while on treatment
  • In 3 of the 7 patients on CAMZYOS and 1 of the 2 patients on placebo, these reductions were asymptomatic
  • In all 7 patients treated with CAMZYOS, LVEF recovered following interruption of CAMZYOS

Discontinuations1

Syncope (0.8%) was the only adverse drug reaction leading to discontinuation in patients receiving CAMZYOS.

LVEF=left ventricular ejection fraction; SD=standard deviation.

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References:

  1. CAMZYOS [package insert]. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  2. National Institutes of Health. NIA adverse events and serious adverse events guidelines. Accessed April 28, 2022. https://www.nia.nih.gov/sites/default/files/2018-09/nia-ae-and-sae-guidelines-2018.pdf