Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a cytotoxic anti-cancer drug directly to the tumor with reduced off-target damage. ADCs combine the targeting capability of monoclonal antibodies with the cancer-killing capability of the payload (linker + cytotoxic drug).
In this webinar, we provide an overview on the functionality of the ADC module within the Simcyp Simulator and how it can be applied to ADC drug development. In addition, we will reflect on the key drug development considerations from the lens of clinical pharmacology and drug metabolism/pharmacokinetics (DMPK).
We will then apply these considerations to an informed case study on the use of PBPK in expediting development. The case study will discuss PADCEV® (enfortumab vedotin), an ADC that is composed of a nectin-4-directed antibody and microtubule inhibitor. This treatment is FDA-approved for patients with locally advanced or metastatic urothelial cancer who have previously received other treatments. We will demonstrate how physiologically-based pharmacokinetic (PBPK) modeling was implemented to predict the potential for drug-drug interactions (DDIs) for enfortumab vedotin in the absence of a clinical DDI trial. By attending this webinar, you’ll learn how PBPK models can be used to predict DDIs for ADC compounds, the challenges that modeling these types of compounds present, and how PBPK modeling of ADCs can impact regulatory interactions.