SA20 The Potential of Real-World Evidence to Complement Basket Trials for Tissue Agnostic Drugs Targeting Neurotrophic Tropomyosin-Related Kinase Gene Fusions

Abstract

Gene fusions involving the neurotrophic tropomyosin-related kinases (NTRK) are a set of biomarkers targeted using tissue agnostic therapy. Because NTRK gene fusions in single tumor types are rare, basket trials are common study designs. With the approval of tissue agnostic drugs- larotrectinib and entrectinib, the feasibility of basket trials has been shown; however, limitations remain. This study aims to identify how alternative studies and study designs have been used to address the limitations of basket trials for rare patient populations treated with tissue agnostic drugs.