- Written by Dr. Cheryl Strelko, Oncology and Infectious Diseases Analyst for GlobalData.
In a press release on August 8, 2012, Amgen announced that the company was halting a late-stage trial of its monoclonal antibody IGF-1 receptor antagonist ganitumab (AMG-479). The 825-patient, Phase III GAMMA (Gemcitabine and AMG-479 in Metastatic Adenocarcinoma of the Pancreas) trial was investigating the combination of ganitumab and Eli Lilly’s Gemzar (gemcitabine) as a first-line treatment for patients with metastatic pancreatic cancer. The company stopped the trial in response to a recommendation from an independent data monitoring committee (DMC). In a planned interim analysis, the DMC concluded that the ganitumab/Gemzar combination was unlikely to significantly improve the overall survival of patients compared to Gemzar monotherapy, GAMMA’s primary endpoint. Amgen also announced it would be stopping a separate Phase II trial investigating the use of ganitumab in locally advanced pancreatic cancer. The GAMMA trial was co-sponsored by Takeda, who has the right to develop and commercialize ganitumab in Japan through collaboration with Amgen.