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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.
News For OMED From The Last 14 Days
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January 29, 2015
08:40 EDTOMEDOncoMed tarextumab granted ODD by FDA
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January 28, 2015
09:06 EDTOMEDOncoMed receives orphan status for tarextumab as pancreatic cancer treatment
The FDA granted OncoMed orphan status for tarextumab, as a treatment for pancreatic cancer. Note that earlier the FDA also granted the drug orphan status as a treatment for small cell lung cancer. Reference Link
08:11 EDTOMEDOncoMed receives orphan status for tarextumab
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January 16, 2015
14:33 EDTOMEDOncoMed presents final Phase 1b data for Tarextumab
OncoMed Pharmaceuticals presented final safety, efficacy and biomarker data from the company's Phase 1b "ALPINE" clinical trial of tarextumab in 40 patients with frontline metastatic pancreatic cancer. Tarextumab was generally well tolerated when administered with gemcitabine and Abraxane, with manageable, on-target drug-related toxicities. The Phase 2 dose of tarextumab was determined to be 15 mg/kg every two weeks in combination with the standard-of-care. Among patients evaluable for response using RECIST criteria, 38% achieved partial responses, with an additional 35% achieving stable disease for an overall clinical benefit rate of 73%. Median progression-free survival and overall survival values for the three drug combination of tarextumab-gemcitabine-Abraxane were 5.6 months and 11.6 months, respectively, for all patients treated with the three-drug combination. The data presented included biomarker analyses that showed that among patients whose tumor samples had elevated levels of Notch3 gene expression, trends toward higher response rates and longer survival were noted, as compared to patients with low Notch3 expression. Median PFS and OS for patients with high Notch 3 expression were 6.6 months and 14.6 months, respectively. Given the small sample size and potential imbalances in patient characteristics, these encouraging preliminary efficacy and predictive biomarker observations are being assessed in the ongoing randomized, placebo-controlled, Phase 2 ALPINE trial

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