Results Expected in the First Half of 2017
REDWOOD CITY, Calif., Sept. 01, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical development-stage biopharmaceutical company focused on discovering and developing novel anti-cancer stem cell and immuno-oncology therapeutics, today announced the completion of patient enrollment of 207 patients in the randomized Phase 2 "YOSEMITE" clinical trial of demcizumab (anti-DLL4, OMP-21M18) for the treatment of first-line metastatic pancreatic cancer. Topline results are expected in the first half of 2017.
The YOSEMITE trial was designed to assess the efficacy and safety of demcizumab in combination with Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) plus gemcitabine (standard of care) compared to standard of care alone. The Phase 2 dose of demcizumab was 3.5 mg/kg every two weeks for up to 70 days. The primary endpoint of YOSEMITE is progression-free survival. Secondary and exploratory endpoints include overall survival, response rate, pharmacokinetics, immunogenicity, safety and biomarker analyses. Patients enrolled in the YOSEMITE Phase 2 were randomized into one of three study arms receiving 1) standard of care plus one course of demcizumab, 2) standard of care plus demcizumab followed by a second course of demcizumab after a 98-day wash-out period or 3) standard of care plus placebo. The YOSEMITE Phase 2 trial was conducted at 49 clinical sites in the U.S., Europe and Australia. OncoMed initiated YOSEMITE in April 2015.
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OncoMed Pharmaceuticals Completes Enrollment of Phase 2 YOSEMITE Clinical Trial of Demcizumab in Pancreatic Cancer