Demcizumab Plus Standard of Care Yields Median Overall Survival of 12.7 Months
REDWOOD CITY, Calif., Jan. 22, 2016 (GLOBE NEWSWIRE) -- OncoMed Pharmaceuticals Inc. (NASDAQ:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, announced updated survival data from the company's Phase 1b clinical trial of demcizumab (anti-DLL4, OMP-21M18) at the Gastrointestinal Cancers Symposium.
The Phase 1b dose-escalation and expansion study assessed the safety, biomarker, and anti-tumor activity of demcizumab and gemcitabine plus Abraxane® (paclitaxel protein-bound particles for injectable suspension) (albumin bound) in 32 previously untreated patients with advanced pancreatic cancer. Demcizumab in combination with chemotherapy had an acceptable safety profile. The updated Kaplan-Meier estimated median progression-free survival was 7.1 months and median overall survival was 12.7 months for the patients who received the demcizumab-gemcitabine-Abraxane combination. Current standard-of-care treatment for advanced pancreatic cancer with gemcitabine and Abraxane, based on Phase 3 data, has median progression-free survival of 5.5 months and median overall survival of 8.5 months.1
"Pancreatic cancer remains a difficult-to-treat tumor and patients with this disease are in need of new and improved treatment options. We are very encouraged by the safety and early efficacy results observed in our Phase 1b clinical trial of demcizumab in pancreatic cancer," said Jakob Dupont, M.D., OncoMed's Chief Medical Officer. "In this updated data set from our Phase 1b study of demcizumab plus standard of care in thirty-two patients with pancreatic cancer, we are pleased to see the median overall survival extend beyond 12.5 months. Overall, the safety, response, progression-free and overall survival data observed in our single-arm Phase 1b clinical study support our ongoing Phase 2 randomized YOSEMITE clinical trial for the treatment of first-line metastatic pancreatic cancer."
A randomized Phase 2 "YOSEMITE" trial in first-line pancreatic cancer patients with metastatic disease is currently being conducted at more than 50 centers in the U.S., Canada, Europe and Australia. Approximately 200 patients will be randomized into one of three study arms. Patients in Arm 1 will receive standard-of-care gemcitabine plus Abraxane plus placebo. Patients in Arm 2 patients will receive standard of care plus one course of demcizumab 3.5 mg/kg every two weeks for six doses (70 days). Patients in Arm 3 will receive standard of care with demcizumab for two courses. OncoMed expects to complete enrollment of the Phase 2 trial in 2016 and data from this trial is anticipated in early 2017.
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OncoMed Presents Updated Phase 1b Data for Demcizumab in First-Line Pancreatic Cancer at the Gastrointestinal Cancers Symposium