I-SPY adapts

The Phase III failure of the first targeted therapy to graduate from I-SPY 2 does not mean the platform trial wasn’t able to predict the correct outcome. What it does mean is that I-SPY 2 cannot distinguish the relative contributions of the components of a novel combination regimen -- which isn’t what it was designed to do anyway.

According to I-SPY 2, adding the combination of veliparib from AbbVie Inc. and carboplatin to standard of care had an 88% chance of significantly increasing pathologic complete response (pCR) over SOC alone in a Phase III trial in neoadjuvant triple-negative breast cancer (TNBC). ...