Puma Biotechnology Reveals Positive Data From I-SPY 2 TRIAL

(RTTNews) - Puma Biotechnology, Inc. (PBYI), a development stage biopharmaceutical company, announced top line results from the Phase II clinical trial of Puma's investigational drug PB272 for the neoadjuvant treatment of breast cancer or I-SPY 2 TRIAL.

The company said the I-SPY 2 TRIAL or Investigation of Serial Studies to Predict Your Therapeutic Response with Imaging And moLecular Analysis 2 is a randomized Phase II clinical trial for women with newly diagnosed Stage 2 or higher breast cancer that addresses whether adding investigational drugs to standard chemotherapy in the neoadjuvant setting is better than standard chemotherapy.

Also, the primary endpoint is pathological complete response in the breast and the lymph nodes at the time of surgery. The goal of the trial is to match investigational regimens with patient subsets on the basis of molecular characteristics that benefit from the regimen.

The I-SPY 2 TRIAL involves an adaptive trial design based on Bayesian predictive probability that a regimen will be shown to be statistically superior to standard therapy in an equally randomized 300-patient confirmatory trial.

The company said regimens that have a high Bayesian predictive probability of showing superiority in at least one of 10 predefined signatures graduate from the trial. Regimens are dropped for futility if they show a low predictive probability of showing superiority over standard therapy in all 10 signatures.