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July 22, 2014
16:27 EDTPBYIPuma Biotechnology reports positive top line results from Phase III PB272 trial
Puma Biotechnology announced top line results from the Phase III clinical trial of Puma's investigational drug PB272 for the extended adjuvant treatment of breast cancer, or ExteNET Trial. The ExteNET trial is a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab in women with early stage HER2-positive breast cancer. More specifically, the ExteNET trial enrolled 2,821 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomized to receive extended adjuvant treatment with either neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ, or DCIS, or death for a period of two years after randomization in the trial. The primary endpoint of the trial was disease free survival, or DFS. The results of the trial demonstrated that treatment with neratinib resulted in a 33% improvement in disease free survival versus placebo. The hazard ratio was determined to be 0.67 which was statistically significant with a p-value of 0.0046. The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ, or DFS-DCIS. The results of the trial demonstrated that treatment with neratinib resulted in a 37% improvement in disease free survival including ductal carcinoma in situ versus placebo. The hazard ratio was determined to be 0.63 which was statistically significant with a p-value of 0.0009. Based on these results from the ExteNET study, Puma plans to file for regulatory approval of neratinib in the extended adjuvant setting in the first half of 2015.
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April 14, 2015
08:46 EDTPBYIPuma Biotechnology expands cohort in Phase II PB272 trial
Puma Biotechnology has expanded the second cohort from its Phase II clinical trial of its lead drug candidate PB272 as a single agent in patients with solid tumors who have an activating HER2 mutation. The cohort that has been expanded is the cohort that includes patients with metastatic non-small cell lung cancer and whose tumors have a HER2 mutation. The Phase II basket trial, which was initiated in October 2013, is an open-label, multicenter, multinational study to evaluate the safety and efficacy of PB272 administered daily to patients who have solid tumors with activating (driver) ERBB mutations, including epidermal growth factor receptor, HER2 and HER3. The cohorts (baskets) included in the study are (1) bladder/urinary tract cancer; (2) breast cancer; (3) colorectal cancer; (4) endometrial cancer; (5) gastric/esophageal cancer; (6) ovarian cancer; (7) all other solid tumors with a HER2 mutation; (8) EGFR mutated and/or amplified primary brain cancer; and (9) solid tumors with a HER3 mutation. The non-small cell lung cancer patients initially entered the study in the “other solid tumors with a HER2 mutation” basket and due to the preliminary activity seen in the trial the Company has expanded the basket, as per the protocol for the trial. The expanded HER2 mutant NSCLC basket will now enroll a total of 18 patients.

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