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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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February 8, 2016
08:10 EDTOMEDOncoMed: FDA says PINNACLE trial should continue under supervision
Following notification of the ALPINE DSMB's findings, OncoMed (OMED) initiated interactions with tarextumab clinical investigators, partner GlaxoSmithKline (GSK), the FDA and the PINNACLE trial's DSMB chairperson to assess potential impact of these results on the overall development program, including the ongoing Phase 2 PINNACLE trial in small-cell lung cancer patients. PINNACLE trial investigators received an addendum to the informed consent form that included a description of the interim analysis from ALPINE. The FDA and the PINNACLE DSMB were provided unblinded data from both Phase 2 trials, a description of OncoMed's exploratory analysis of the ALPINE results and related trial materials for review. The independent analyses of the FDA and PINNACLE DSMB indicated that the PINNACLE trial could continue under the supervision of the PINNACLE DSMB monitoring for safety and efficacy and that appropriate safeguards are in place. OncoMed is conducting the PINNACLE Phase 1b/2 clinical trial of tarextumab for the treatment of small cell lung cancer. The randomized Phase 2 trial is comparing progression-free survival outcomes for patients treated with tarextumab administered at 15 mg/kg every three weeks in combination with etoposide and cisplatin or carboplatin versus patients who receive placebo plus chemotherapy. Additionally, PFS will be assessed using a predictive biomarker for high tumor Notch3 expression. Secondary endpoints for the Phase 2 study include overall survival, overall response rate, pharmacokinetics, safety and other biomarkers. The PINNACLE study is being conducted at about 40 sites in the U.S. and is expected to enroll approximately 130 patients. Results from the Phase 2 PINNACLE trial are anticipated in 2017.
08:09 EDTOMEDOncoMed discontinues dosing in ALPINE trial, unblinds study
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