The initial results from I-SPY 2 are a fine rebuttal to industry skeptics who doubted the academic groups in charge had the ability to quickly run a robust clinical trial across multiple tumor types. In less than two years, the adaptive Phase II study in breast cancer has enabled decisions to advance two compounds to Phase III in specific patient subgroups - and to stop investigation of those compounds in a combined 10 other subgroups.

The goal of I-SPY 2 is to test unapproved compounds in up to eight different biomarker-defined subgroups of patients with neoadjuvant breast cancer and use Bayesian statistics to predict specific groups in which a compound has at least an 85% chance of success in a Phase III trial.