EXPERT REVIEW Preclinical Pharmacokinetic Considerations for the Development of Antibody Drug Conjugates

ABSTRACT Antibody drug conjugates (ADCs) are an emerg-ing new class of targeted therapeutics for cancer that use antibod-ies to deliver cytotoxic drugs to cancer cells. There are two FDA approved ADCs on the market and over 30 ADCs in the clinical pipeline against a number of different cancer types. The structure of an ADC is very complex with multiple components and considerable efforts are ongoing to determine the attributes nec-essary for clinical success. Understanding the pharmacokinetics of an ADC and how it impacts efficacy and toxicity is a critical part of optimizing ADC design and delivery i.e., dose and schedule. This review discusses the pharmacokinetic considerations for an ADC and tools and strategies that can be used to evaluate molecules at the preclinical stage. KEY WORDS antibody drug conjugate. biotherapeutics. cancer. pharmacokinetics. preclinica