Certara scientists developed a mechanistic QSP model that accurately translates preclinical antibody-drug conjugates (ADC) data into clinical outcomes. Using trastuzumab emtansine (Kadcyla™) as a model compound, this study demonstrates how integrated pharmacokinetic, efficacy, and thrombocytopenia modeling can help optimize dose selection and inform clinical trial design for next-generation antibody-drug conjugates.

Key Highlights:

• Mechanistic modeling of ADC efficacy and toxicity (thrombocytopenia)
• Translation from in vitro and in vivo data to virtual clinical populations
• Application to metastatic breast cancer (mBC) and HER2-targeting ADCs