Publications by authors named "Keilah Fenech"
The statistical assessments needed to establish anti-drug antibody (ADA) assay cut points (CPs) can be challenging for bioanalytical scientists. Poorly established CPs that are too high could potentially miss treatment emergent ADA or, when set too low, result in detection of responses that may have no clinical relevance. We evaluated 16 validation CP datasets generated with ADA assays at Regeneron's bioanalytical laboratory and compared results obtained from different CP calculation tools.
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- - The study explored the effectiveness of cemiplimab as a neoadjuvant therapy for patients with resectable cutaneous squamous-cell carcinoma, aiming to determine its impact on achieving a pathological complete response before surgery.
- - Out of 79 participants, 51% achieved a pathological complete response, while 68% showed a positive response on imaging; these outcomes suggest cemiplimab is effective for this patient group.
- - However, 87% of patients experienced adverse events, highlighting the need for careful monitoring and further research to balance treatment benefits with potential side effects.