Exposure-tumour growth inhibition modelling of brigimadlin using phase I solid tumour data to support phase II dose selection.

Aims: Brigimadlin (BI 907828) is a potent, oral MDM2-p53 antagonist under clinical investigation for the treatment of advanced solid tumours. A brigimadlin exposure-tumour growth inhibition (E-TGI) model was developed to support the recommended phase II dose (RP2D) selection of brigimadlin in future clinical trials.

Methods: Population modelling was applied to analyse longitudinal tumour size (sum of longest diameters, SLD) data of 151 patients from a phase I trial treated with 5-80 mg brigimadlin every third or fourth week (q3w/q4w).