Amgen announced a decision to stop the ganitumab Phase 3 GAMMA trial following the recommendation of an independent Data Monitoring Committee overseeing the trial. Based on the review 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. 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 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.
- Data Monitoring Committee