Data from a small, randomized, placebo-controlled Phase II study of Amgen's (NASDAQ: AMGN) AMG 479 plus gemcitabine showed that metastatic pancreatic cancer patients receiving the combination experienced improved overall survival at six months. The promising candidate now is moving into Phase III testing in this patient population.
In the study, patients received either AMG 479 plus Gemzar (gemcitabine), conatumumab plus gemcitabine, or placebo plus gemcitabine. The addition of AMG 479 to gemcitabine resulted in an overall survival rate at six months of 57 percent versus 50 percent with gemcitabine alone, and 39 percent versus 23 percent at 12 months. Median overall survival was 8.7 months versus 5.9 months in the gemcitabine arm. Patients receiving AMG 479 also experienced longer progression-free survival of 5.1 months versus 2.1 months, according to an Amgen statement.
Pancreatic cancer is the fourth leading cause of cancer-related death in the U.S. In 2009, there were more than 42,000 new cases and 35,000 deaths from the disease. "Pancreatic cancer has the worst survival of any solid tumor, and novel approaches to treat this disease are needed," says Dr. Hedy Kindler, associate professor of Medicine, medical director, Gastrointestinal Oncology and director, Mesothelioma Program, University of Chicago Medical Center. "In this study, AMG 479 demonstrated promising activity, extending progression-free survival three months and overall survival nearly three months compared to gemcitabine alone."
- see the Amgen release