Assessing Current Clinical Biomarkers & Defining a Future Gold Standard for Surrogate Endpoints in Glioblastoma Clinical Development
- Join this workshop to establish a future direction towards achieving a gold standard surrogate endpoint for GBM clinical trials
- Discussing innovative, non-invasive strategies for dose selection and defining a biologically effective dose in GBM trials such as using advanced imaging biomarkers and liquid biopsies from CSF to overcome the infeasibility of serial brain biopsies
- Exploring the challenges in gaining regulatory approval and validate advanced imaging biomarkers to build a strong scientific case for their use as reliable indicators of therapeutics response
- Diving into the limitations of using ‘Progression Free Survival’ as a surrogate endpoint for overall survival in GBM due to pseudo-progression and designing trials that can use complementary endpoints to accurately differentiate between treatment-based inflammation and true disease progression
- Addressing the FDA’s hesitation to accept PFS as a standalone surrogate for accelerated approval in GBM
- Exploring alternative or composite endpoints that could meet regulatory standards