Amgen, a biotechnology company, has announced the termination of its Phase III Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas (GAMMA) trial.
AMG 479, or ganitumab, is an investigational, fully-human, monoclonal antibody that targets type 1 insulin-like growth factor receptor (IGF1R).
Go deeper with GlobalData
The decision to terminate the Phase III GAMMA trial follows the recommendation of an independent Data Monitoring Committee (DMC) overseeing the study.
Amgen research and development executive vice president Dr Sean Harper said the disappointing results highlight problems treating pancreatic cancer, which continues to be a significant unmet medical need.
"We would like to thank the patients, caregivers and investigators for their participation and engagement in the study," Dr Harper said.
On the basis of a pre-planned interim analysis, 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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataNo safety concerns were raised in the DMC review of the randomised, multicentre, double-blind study.
The Phase III trial was designed to determine if ganitumab and gemcitabine improves overall survival, when compared to placebo and gemcitabine, in the first-line treatment of patients with metastatic adenocarcinoma of the pancreas.
Amgen is in the process of notifying study investigators that treatment with ganitumab should be discontinued in the GAMMA trial. It will also be withdrawn from a separate ongoing Phase II trial in locally advanced pancreatic cancer.
Image: Amgen headquarters: the company are discontinuing the GAMMA trial. Photo: courtesy of Coolcaesar.
