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December 7, 2012
18:05 EDTPBYIPuma Biotechnology announces positive PB272 Phase 2 data at symposium
Puma Biotechnology announced that results from an ongoing Phase II clinical trial of Puma's investigational drug PB272 (neratinib) were presented at the 2012 CTRC-AACR San Antonio Breast Cancer Symposium that is currently taking place in San Antonio, Texas. 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 27 patients evaluable for safety were grade 3 diarrhea (22% of patients), grade 3 mucositis (15%), grade 3 hyperglycemia (4%), grade 3 leukopenia (4%), and grade 3 fatigue (4%). The efficacy results from the trial showed that for the 27 evaluable patients, 12 patients (44%) experienced a partial response (PR) and 1 patient (4%) experienced prolonged stable disease (SD) for greater than 6 months, which translates to a clinical benefit rate of 48%. 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%. Clinical benefit was seen in patients previously treated with trastuzumab as well as lapatinib, T-DM1 and pertuzumab. The median progression free survival of the 27 evaluable patients was seen to be 18 weeks (4.2 months). Enrollment in this trial is continuing and is anticipated to reach a total of 34 patients. Tumor biopsies were also taken from patients prior to entry into the trial in order to assess expression or mutational changes in phosphatase and tensin homolog (PTEN) and phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) and to correlate them with response to the combination of PB272 and temsirolimus. Of the 9 patients whose tumors were analyzed for PIK3CA mutation status, 2 patients were found to have mutated PIK3CA. Treatment with the combination of PB272 and temsirolimus resulted in clinical benefit (defined as PR or SD) in 2 (100%) of these patients. Of the 17 patients whose tumors were analyzed for PTEN status, 8 patients were shown to have reduced PTEN expression and 7 patients were shown to have absent PTEN expression. Treatment with the combination of PB272 and temsirolimus resulted in clinical benefit (PR or SD) in 7 (88%) of the 8 patients with reduced PTEN expression and in 6 (86%) of the 7 patients with absent PTEN expression.
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