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According to the results of a Phase II clinical trial, treatment of metastatic pancreatic cancer with a combination of AMG 479 and Gemzar® (gemcitabine) resulted in better progression-free and overall survival than treatment with Gemzar alone. These results were presented at the 2010 annual meeting of the American Society of Clinical Oncology.

Pancreatic cancer is one of the deadliest forms of cancer. Each year, approximately 43,000 people are diagnosed with pancreatic cancer in the United States and more than 37,000 die from the disease. The disease is often diagnosed at an advanced stage, and improved approaches to early detection and treatment are important research priorities.

AMG 479 is an investigational therapy that targets the type 1 insulin-like growth factor receptor (IGF-1R). Signaling through this receptor plays an important role in the regulation of cell growth and survival. 

To evaluate the potential role of AMG 479 in the treatment of pancreatic cancer, researchers conducted a Phase II clinical trial. The study involved 121 patients with metastatic pancreatic cancer. Patients were assigned to one of three treatment groups: 1) Gemzar alone; 2) Gemzar plus AMG 479; or 3) Gemzar plus conatumumab. Conatumumab is another investigational targeted therapy.

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  • At six months, overall survival was 57% among patients treated with Gemzar plus AMG 479, 59% among patients treated with Gemzar plus conatumumab, and 50% among patients treated with Gemzar alone.
  • At 12 months, overall survival was 39% among patients treated with Gemzar plus AMG 479, 20% among patients treated with Gemzar plus conatumumab, and 23% among patients treated with Gemzar alone.
  • Progression-free survival was 5.1 months among patients treated with Gemzar plus AMG 479, 4.0 months among patients treated with Gemzar plus conatumumab, and 2.1 months among patients treated with Gemzar alone.

Serious (grade 3 or higher) side effects that were more common among patients treated with Gemzar and AMG 479 than among patients treated with Gemzar alone included neutropenia (low white blood cell counts), thrombocytopenia (low platelet counts), and fatigue.

These results suggest that the addition of AMG 479 to Gemzar may improve survival with metastatic pancreatic cancer. AMG 479 will be further evaluated in a Phase III clinical trial.

Reference: Kindler HL, Richards DA, Stephenson J et al. A placebo-controlled, randomized phase II study of conatumumab (C) or AMG 479 (A) or placebo (P) plus gemcitabine (G) in patients (pts) with metastatic pancreatic cancer (mPC). Presented at the 2010 annual meeting of the American Society of Clinical Oncology. June 4-8, 2010. Chicago, IL. Abstract 4035.

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