Receive our newsletter – data, insights and analysis delivered to you
  1. Uncategorized
  2. c-icon icon-chevron-right
August 8, 2012

Amgen terminates ganitumab Phase III GAMMA trial

Amgen, a biotechnology company, has announced the termination of its Phase 3 Gemcitabine and AMG 479 in Metastatic Adenocarcinoma of the Pancreas (GAMMA) trial.

amgen

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).

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.

Content from our partners
Africa’s last mile: Building viable vaccine supply chains
Why this global life sciences COO believes relocation to Charleston, SC, was key to achieving next-level success
Patient-centric pharma logistics: How CRYOPDP delivers hope worldwide

No 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 It will also be withdrawn from a separate ongoing Phase II trial in locally advanced pancreatic cancer.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.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. Key drug pipeline and competitive landscape changes based on the latest clinical activity, sent every Tuesday. Curated analysis and data-driven insights on clinical trials strategy and operations, sent every Thursday. The pharmaceutical industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU