Puma Biotechnology Announces Positive PB272 (Neratinib) Phase II Data at CTRC-American Association for Cancer Research San Antonio Breast Cancer Symposium
Published: Dec 10, 2012
LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NYSE: PBYI), a development stage biopharmaceutical company, 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 (SABCS) that is currently taking place in San Antonio, Texas. The presentation is further detailed below. The Phase II clinical trial of PB272 given in combination with the anticancer drug temsirolimus was conducted at Memorial Sloan-Kettering Cancer Center. The trial was supported by the National Comprehensive Cancer Network®, ASCO’s Young Investigator Award, Susan G. Komen for the Cure®, and the Terri Brodeur Breast Cancer Foundation. The initial Phase I/II results of this trial were presented last year. The Phase II portion of the study, presented at the SABCS, enrolled patients with HER2+ metastatic breast cancer and disease progression on trastuzumab. Patients in the study received a median of 3 prior cytotoxic regimens (range 1-12 prior regimens) before entering the trial. Of the 27 patients enrolled in the trial, 14 patients (52%) had either estrogen receptor positive disease or progesterone receptor positive disease. In addition, 20 patients (74%) had visceral metastases and 3 patients (11%) had brain metastases. Patients were administered PB272 at a dose of 240 mg per day in combination with temsirolimus given at a dose of 8 mg weekly.