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ARTICLE | Clinical News

I-SPY 2 update

July 8, 2016 1:02 AM UTC

Sponsors of the adaptive Phase II I-SPY 2 trial announced five compounds have graduated from the neoadjuvant study with data for the first two candidates published Thursday in the New England Journal of Medicine.

The results showed veliparib from AbbVie Inc. (NYSE:ABBV) had an estimated pathologic complete response (pCR) rate of 51% in 72 patients with triple-negative breast cancer vs. 26% for the control (n=44), with an 88% predicted probability of success in Phase III. Additionally, neratinib from Puma Biotechnology Inc. (NYSE:PBYI) had an estimated pCR of 56% in 115 HER2-positive hormone receptor-negative breast cancer patients vs. 33% for the control group (n=78). The predicted probability of success in Phase III was 79% for neratinib. ...