Case Study: Genentech informs Polivy DDI labeling without clinical trials with Certara's Simcyp PBPK Simulator

PBPK Model Informs Antibody-Drug Conjugate Label for DDIs Without Clinical Trials

Genentech was developing an antibody-drug conjugate called polatuzumab vedotin and needed to assess the risk of CYP3A-mediated drug-drug interactions for its cytotoxic payload. To address this challenge without conducting dedicated clinical trials, they partnered with Certara and utilized the Simcyp PBPK Simulator.

Certara's solution was to develop a physiologically-based pharmacokinetic (PBPK) model to perform an in silico DDI study. The simulations predicted that the drug would not significantly inhibit or induce CYP3A and that strong inhibitors/inducers would have a limited impact. These results were used to directly inform the drug's label and guide the regulatory strategy for its application, saving significant time and resources by avoiding the need for clinical DDI trials.

Genentech