BioCentury
ARTICLE | Clinical News

AbbVie's veliparib graduates I-SPY 2

December 14, 2013 1:29 AM UTC

Researchers at the University of California, San Francisco and colleagues said a regimen containing veliparib ( ABT-888) from AbbVie Inc. (NYSE:ABBV) "graduated" from the open-label Phase II I-SPY 2 trial based on having a high probability of success in patients with triple-negative breast cancer (TNBC) in a Phase III trial. I-SPY 2 is designed to rapidly and inexpensively develop data to support small Phase III trials of new neoadjuvant therapies for locally advanced breast cancer or to help companies quickly kill ineffective candidates. The trial involves an adaptive design based on Bayesian predictive probability that a regimen will be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.

AbbVie could not be reached for next steps for the veliparib-containing regimen. Veliparib is an oral inhibitor of poly(ADP-ribose) polymerase (PARP). Earlier this month, Puma Biotechnology Inc. (NYSE:PBYI) said a regimen containing the company's neratinib "graduated" from I-SPY 2 (see BioCentury Extra, Dec. 4). ...