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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

d grade 3/4 diarrhea.  No patients in the neratinib arm of the trial and 14% of the patients in the lapatinib/capecitabine combination arm of the trial experienced grade 3/4 PPE.  The diarrhea with neratinib was reported to be transient and manageable with antidiarrheal medications. The efficacy results from the trial showed that for the 117 patients in the neratinib monotherapy arm of the trial, 2% of the patients experienced a complete response, 27% of the patients experienced a partial response and 15% of the patients experienced stable disease for greater than 6 months, which translates to an overall response rate of 29% and a clinical benefit rate of 44%.  For the 116 patients in the trial treated with the combination of lapatinib and capecitabine, 4% of the patients experienced a complete response, 36% of the patients experienced a partial response and 23% of the patients experienced stable disease for greater than 6 months, which translates to an overall response rate of 40% and a clinical benefit rate of 63%.  The median progression free survival (PFS) for patients in the neratinib monotherapy arm was 4.5 months and the median PFS for the patients who had received the combination of lapatinib and capecitabine was 6.8 months. 

Combined Inhibition of mTORC1 with Temsirolimus and HER2 with Neratinib:
A Phase I/II Study in Patients with Metastatic HER2-Amplified or Triple-Negative Breast Cancer

The Phase I/II clinical trial of PB272 given in combination with the chemotherapy drug temsirolimus was conducted at Memorial Sloan-Kettering Cancer Center.  The trial was sponsored by Pfizer and the Phase I results of this trial were previously presented last year.  The Phase II portion of the study, presented at this symposium, enrolled patients with either HER2+ metastatic breast cancer and disease progression on trastuzumab or with triple negative breast cancer.  Patients in the study received
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