Amgen Inc. (AMGN: Quote) announced that it has decided to stop the ganitumab, or AMG 479, Phase 3 GAMMA or Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas trial following the recommendation of an independent Data Monitoring Committee or DMC overseeing the trial.
Amgen said the DMC concluded that the addition of ganitumab to gemcitabine is unlikely to demonstrate a statistically significant improvement in the primary endpoint of overall survival compared to gemcitabine alone. There were no safety concerns raised in the DMC review of the study.
The GAMMA study is a randomized, multicenter, double-blind, Phase 3 trial to determine if ganitumab plus gemcitabine improves overall survival, compared to placebo plus gemcitabine, in the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
Amgen said it has communicated with regulatory authorities and is in the process of notifying study investigators that treatment with ganitumab should be discontinued in the GAMMA trial, as well as a separate ongoing Phase 2 trial in locally advanced pancreatic cancer.
Ganitumab is an investigational fully human monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF1R).
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by RTT Staff Writer
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