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Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-AACR San Antonio Breast Cancer Symposium
Date:12/9/2011

a median of 3 prior cytotoxic regimens (range 1-12 prior regimens).  Patients in the HER2+ cohort of the trial received a median of 2 prior trastuzumab containing regimens (range 1-9 prior regimens).  Patients were administered PB272 at a dose of 240 mg per day in combination with temsirolimus given at a dose of 8 mg weekly.

The results of the study presented showed that the combination of PB272 and temsirolimus had acceptable tolerability.  The most frequently observed severe adverse events for the 20 patients evaluable for safety were grade 3 diarrhea (10% of patients), grade 3 hyperglycemia (5%), mucositis (5%), leukopenia (5%), and fatigue (5%). The efficacy results from the trial showed that for the 15 patients with HER2+ disease, 9 (60%) patients experienced a partial response and 1 (7%) patient experienced stable disease for greater than 6 months, which translates to a clinical benefit rate of 67%.  Patients who experienced a partial response to the combination of neratinib plus temsirolimus demonstrated a maximum change in the size of their target lesions of between 33% and 83%.  None of the 5 patients with triple negative breast cancer demonstrated a partial response or stable disease for greater than 6 months.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are pleased with the PB272 data that has been presented at the San Antonio Breast Cancer Symposium.  The combination of PB272 given in combination with capecitabine shows strong evidence of antitumor activity in second and third line HER2+ metastatic patients, which we believe could position the drug well compared to other agents currently used to treat second and third line disease.  In addition, the data on the combination of PB272 in combination with temsirolimus demonstrates intriguing antitumor activity in a heavily pretreated population.  We look forward to continuing to study both of these combination
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SOURCE Puma Biotechnology, Inc.
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