Ganitumab: Phase III discontinued

Amgen and Takeda stopped the double-blind, placebo-controlled, international Phase III GAMMA trial in patients with metastatic adenocarcinoma of the pancreas after an interim analysis by an independent DMC showed that first-line treatment with ganitumab plus gemcitabine was unlikely to meet the primary endpoint of OS vs. gemcitabine alone. No safety concerns were identified. The trial had planned to enroll about 825 patients to receive placebo or 12 or 20 mg/kg IV ganitumab on days 1 and 15 of a 28-day cycle plus gemcitabine on days 1, 8 and 15. Amgen said it also stopped a separate Phase II trial of ganitumab to treat locally advanced pancreatic cancer. ...