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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.
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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