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Amgen Terminates Study of Ganitumab in Metastatic Pancreatic Cancer

Drug was unlikely to improve overall survival when combined with gemcitabine

Based on the review of a preplanned interim analysis, the DMC concluded that the addition of ganitumab (AMG 479) to gemcitabine was unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared with gemcitabine alone.

The GAMMA study was conducted to determine whether ganitumab plus gemcitabine improves overall survival compared with placebo plus gemcitabine in the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.

Amgen is notifying study investigators that treatment with ganitumab should be discontinued in the GAMMA trial, as well as in a separate ongoing phase II study in locally advanced pancreatic cancer.

Ganitumab is an investigational fully human monoclonal antibody that targets the type-1 insulin-like growth factor receptor (IGF1R).

For more information, visit the Amgen Web Site.

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