Publication: Clinical Pharmacology & Therapeutics (CPT) — published by Wiley on behalf of the American Society for Clinical Pharmacology and Therapeutics (ASCPT)
Abstract
Bispecific T-cell Engagers (TCEs) are promising anti-cancer treatments that bind to both the CD3 receptors on T cells and an antigen on the surface of tumor cells, creating an immune synapse that leads to killing of malignant tumor cells. These novel therapies come with unique development challenges, including specific safety risks such as cytokine release syndrome. These on-target adverse events can be mitigated and deconvoluted from efficacy via innovative dosing strategies, making clinical pharmacology a key discipline in the development of these therapies.
Authors: Mohamed Elmeliegy (Pfizer Inc.), Joseph Chen (Genentech Inc.), Aruna Dontabhaktuni (PharmaPro Consulting Inc.), Allison Gaudy (Bristol-Myers Squibb), Georgi I. Kapitanov (Applied BioMath, LLC), Junyi Li (Genentech Inc.), Sabiha R. Mim (PharmaPro Consulting Inc.), Sharad Sharma (Boehringer Ingelheim Pharmaceuticals), Qin Sun (FDA, Office of Clinical Pharmacology), Sihem Ait-Oudhia (Merck & Co.)
Published: online July 4, 2024; print issue September 2024 (Vol. 116, Issue 3, pp. 637–646)
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