Keytruda graduates from I-SPY 2

Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) has graduated from the adaptive Phase II I-SPY 2 trial in three neoadjuvant breast cancer indications, the study's lead statistician Don Berry told BioCentury. He said Keytruda graduated in HER2-negative; hormone-receptor (HR)-positive, HER2-negative; and triple-negative breast cancer (TNBC).

I-SPY 2 involves an adaptive trial design based on Bayesian predictive probability that a regimen will be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial. Candidates for which the expected success rate is at least 85% are considered to have graduated (see BioCentury, Feb. 3, 2014)...