"Evaluating Immuno-Oncology Treatment With PK/PD Modelling "

Workshop

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12. Evaluating Immuno-Oncology Treatment With PK/PD Modelling (3-hour short course). World Preclinical Congress Europe (Cambridge Innovation Institute), Sheraton Lisboa Hotel & Spa, Lisbon (11/2017) PDF

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Objectives

• Introduce how translational PK/PD modelling for chemotherapy and cell-directed targeted therapy can be used to relate preclinical data with clinical response

• The basics of PK/PD modelling that are relevant to evaluating novel immuno-oncology treatments

• Learn about dose selection, estimation of therapeutic window, and translational sciences based on PK/PD modelling

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Lecture 1. Translational modelling for cell-directed cancer therapies: the successful case studies 

The lecture will provide a historical perspective for translational modelling that has been developed for chemotherapies and cancer cell-directed targeted therapies. It will discuss the following topics: 

• How do we define the quantitative relationship between preclinical efficacy and clinical activity for this type of treatment? 

• What does compelling preclinical evidence entail? 

• Is it possible to set minimum preclinical efficacy criteria to qualify a novel treatment for clinical success?

 

Group exercise 1 

• Limitations of the approach/conclusions 

• How shall this translational modelling framework be used in practice to best support drug projects? 

• Where does it add value? 

• Which ideas can be borrowed to support immuno-oncology projects? 1

 

Lecture 2. The basics of immuno-oncology modelling

This lecture will focus on the basics of immuno-oncology modelling, including: 

• Target-mediated drug disposition (TMDD): translating preclinical antibody PK into the clinics 

• Target engagement modelling: a MABEL example

Case study: Predict human PK using in vitro and monkey data with Target Mediated Drug Disposition (TMDD) modelling

Case study: First-in-human (FIH) dose finding for bispecific immunomodulatory P-Cadherin LP-DART with mechanistic PK/PD modelling MABEL approach

 

Group exercise 2 

• What are the main gaps from target engagement to disease modulation to (preclinical and clinical) outcome? 

• How to fill in these gaps in practice to enable robust clinical translation of preclinical results?