Unique challenges posed by Enrichment Strategies in Oncology combination drug development
*Ram Suresh, GlaxoSmithKline 

Keywords: Predictive enrichment, combination products

Predictive Enrichment Designs have dominated the molecularly targeted agent (MTA)-era in Oncology, giving rise to many life-saving drugs. However, recent examples in oncology suggest that enrichment strategies need further adaptation, especially in combination drug development. The unique challenges presented by combination products with enrichment strategies will be demonstrated via two major drug development examples. In addition, a novel enrichment approach that enables studying multiple cancers simultaneously will be presented. The clinical appeal and the statistical/regulatory challenges associated with this design will be discussed.