FG-3019: Additional Phase I/II data

FibroGen said there was a significant relationship between patient survival and trough plasma levels of FG-3019 (Cmin) in 75 patients with locally advanced or metastatic pancreatic ductal adenocarcinoma in a single-arm, open-label, dose-escalation, U.S. Phase I/II trial evaluating IV FG-3019 plus Tarceva erlotinib and gemcitabine. Specifically, patients with a Cmin of FG-3019 - measured immediately before the second dose at day 15 - of >=150 ug/mL had a median OS of 9.4 months vs. 4.8 months for patients with a Cmin of FG-3019 of <150 ug/mL (p=0.03). Additionally, the 1-year survival rate was 37% in patients with a Cmin of FG-3019 of >=150 ug/mL vs. 11% in patients with a Cmin of FG-3019 of <150 ug/mL.

Patients received 3, 10, 15, 25, 35 or 45 mg/kg FG-3019 every other week plus Tarceva and gemcitabine starting at day 15; or 17.5 or 22.5 mg/kg FG-3019 weekly after a double loading dose plus Tarceva and gemcitabine starting at day 15. Data were presented at the American Society of Clinical Oncology meeting in Chicago. FibroGen previously reported interim data from the trial (see BioCentury, Jan. 31, 2011). ...