Life After I-SPY Graduation: Neratinib Likely To Be Tested With Roche’s Perjeta
This article was originally published in Pharmaceutical Approvals Monthly
I-SPY 2 investigators are buoyed by “strong signal” for neratinib in high-risk subgroup in adaptive design study. Investors, however, are underwhelmed by results.
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Five neoadjuvant breast cancer regimens have been tested successfully in I-SPY Phase II program, but three have not moved on to sponsor-driven pivotal testing and the I-SPY 3 master protocol has yet to be used.
Publication in NEJM of results from Phase II of master protocol study of breast cancer combinations also helps build support for Bayesian statistics.
The five-year I-SPY 2 study is a model for drug development and an innovative screening process for identifying winners, FDA's Woodcock says.