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ARTICLE | Clinical News

CRS-207: Updated Phase II data

February 10, 2014 8:00 AM UTC

Updated data from an open-label, U.S. Phase II trial in 93 patients with metastatic pancreatic cancer showed that CRS-207 plus GVAX Pancreas cancer vaccine and cyclophosphamide led to a median OS, the primary endpoint, of 6.1 months at a median follow up of 7.8 months vs. 3.9 months for GVAX Pancreas and cyclophosphamide alone (p=0.011). The 1-year OS rate for the CRS-207 arm was 24% vs. 12% for the control arm. In a predefined subgroup of patients who received >=3 doses in either treatment arm, median OS was 9.7 months in the CRS-207 arm vs. 4.6 months in the control arm (p=0.017). The trial enrolled patients with metastatic pancreatic ductal adenocarcinoma (PDA) who received or refused >=1 prior chemotherapy regimen to receive 2 doses of GVAX Pancreas and cyclophosphamide followed by 4 doses of CRS-207 or 6 doses of GVAX Pancreas and cyclophosphamide every 3 weeks. Data were presented at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium in San Francisco. ...