REVEAL Study Meets Primary Endpoints
Bayer has announced detailed results from the Phase III REVEAL study of investigational positron emission tomography (PET) radiotracer iodine 124 evuzamitide (I 124 evuzamitide) for the diagnosis of cardiac amyloidosis. The investigator-initiated study by Brigham and Women’s Hospital met its primary endpoints for sensitivity and specificity based on visual scan interpretation.
The results were presented as a late-breaking oral presentation at the European Society of Cardiology (ESC) Congress 2026 in Munich, on August 30, and simultaneously published in The Journal of the American Medical Association.
Secondary endpoints assessing diagnostic performance in light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) also met the predefined success criteria in the overall population.
Diagnostic Performance and Safety Findings
REVEAL was a multicenter, open-label, single-arm Phase III study conducted at 18 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis.
The primary analyses assessed sensitivity and specificity based on visual scan interpretation by three independent readers:
- Sensitivity: Reader 1: 94% (95% CI, 85% to 98%); Reader 2: 94% (95% CI, 85% to 98%); Reader 3: 90% (95% CI, 81% to 95%)
- Specificity: Reader 1: 84% (95% CI, 75% to 91%); Reader 2: 85% (95% CI, 76% to 92%); Reader 3: 89% (95% CI, 81% to 95%)
- Majority read: Sensitivity was 94% (95% CI, 85% to 98%) and specificity was 86% (95% CI, 77% to 92%)
Secondary efficacy endpoints also met predefined success criteria:
- ATTR: Majority-read sensitivity was 96% (95% CI, 87% to 100%) and specificity was 86% (95% CI, 77% to 92%)
- AL: Majority-read sensitivity was 95% (95% CI, 76% to 100%) and specificity was 86% (95% CI, 77% to 92%)
Among the 170 patients who received I 124 evuzamitide, 55 (32.4%) experienced at least one treatment-emergent adverse event (TEAE) from Day 1 to Day 30. Of these, 11 (6.5%) experienced a serious TEAE unrelated to I 124 evuzamitide. Only one TEAE, fatigue, was considered related to I 124 evuzamitide.
The most common TEAEs, occurring in more than 1% of participants, were:
- Upper respiratory tract infection: 2.9%
- Dizziness: 2.4%
- Nausea: 1.8%
- Vomiting: 1.8%
- Syncope: 1.8%
- Hyperglycemia: 1.8%
- Skin laceration: 1.8%
There were no deaths or evuzamitide-related TEAEs leading to discontinuation during the study period.
Regulatory Status
I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication.
The radiotracer was previously granted Breakthrough Therapy Designation by the U.S. FDA for PET imaging in patients with suspected or known cardiac amyloidosis. It was also granted Orphan Drug status for both AL and ATTR in the U.S. and the EU.
Bayer plans to discuss the REVEAL data and submission for regulatory approval with the FDA and other health authorities.
Source: Bayer AG
