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January 17, 2014
08:36 EDTOMEDOncoMed presents data from Phase 1b clinical trial of demcizumab
OncoMed presented data from its ongoing Phase 1b clinical trial of demcizumab in first-line Stage IV pancreatic cancer patients. Demcizumab was generally well tolerated in combination with both gemcitabine and Abraxane with fatigue, hypertension, nausea and vomiting being the most common drug-related toxicities. No demcizumab-related reversible cardiotoxicity events have occurred with the implementation of regular monitoring, a truncated treatment approach and cardioprotective medication, if indicated. The combination of gemcitabine with or without Abraxane did not appear to influence the pharmacokinetics of demcizumab. 50% evaluable patients who received the demcizumab/gemcitabine/Abraxane combination had partial responses as measured by RECIST and two patients had stable disease resulting in a clinical benefit rate of 83%. A randomized Phase 2 clinical trial in patients with first-line pancreatic cancer is planned for the second half of 2014.
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July 16, 2014
08:32 EDTOMEDOncoMed initiates Phase 2 ALPINE trial of tarextumab
OncoMed Pharmaceuticals announced that patient dosing has begun in the randomized, placebo-controlled Phase 2 portion of the company's "ALPINE", or Antibody therapy in first-Line Pancreatic cancer Investigating anti-Notch Efficacy and safety, clinical trial of its anti-Notch 2/3 cancer stem cell antibody, tarextumab, being studied for the treatment of pancreatic cancer. Tarextumab is being tested in combination with Abraxane plus gemcitabine in patients with previously untreated stage IV pancreatic cancer. The ALPINE trial is being conducted at up to 30 sites in the U.S. and is expected to enroll approximately 124 patients. The Phase 2 clinical trial will compare the progression-free survival, or PFS, of 15 mg/kg tarextumab administered every two weeks versus placebo in combination with Abraxane plus gemcitabine in all patients. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary and exploratory endpoints, including overall survival and overall response rate, pharmacokinetics, safety and other biomarkers, will also be evaluated.

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