Monday, February 3, 2014
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.