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|FibroGen Announces Early Phase 2 Data From a Clinical Study of FG-3019 in Combination With Chemotherapy as Neoadjuvant in Locally Advanced, Unresectable Pancreatic Cancer|
In this study (NCT02210559), patients with inoperable locally advanced pancreatic cancer, assessed by CT scans, are carefully staged with PET scans, endoscopic tissue biopsies, and laparoscopy. Subjects are randomized to six cycles of chemotherapy with gemcitabine and nab-paclitaxel with or without FG-3019. The study is targeted to enroll a total of 42 subjects, so these data represent an early assessment.
Twelve subjects out of the total target of 42 have been enrolled to date. Among the 6 randomized to FG-3019 plus chemotherapy, 2 are still on treatment, 1 discontinued treatment due to complications of chemotherapy and 3 completed treatment. Tumors in the 3 subjects who completed treatment were considered operable after treatment. Two subjects had complete tumor removal (R0) and one subject had microscopic tumor remaining after surgery (R1). Among the 6 subjects randomized to chemotherapy alone, 2 are still on treatment, 2 subjects discontinued treatment due to tumor progression during the course of the study, and two subjects completed treatment. Of the two subjects who completed treatment, one was considered to have operable cancer and had a complete tumor removal (R0). After 2 cycles of treatment in these first 12 subjects, plasma levels of CA19.9, a non-specific tumor marker, showed a mean reduction of 78.3% with FG-3019 plus chemotherapy compared to 48.7% with chemotherapy alone. An additional advantage of the study is that it will provide tumor biopsy samples with which we plan to assess changes in biomarkers of the tumor, stroma, and inflammatory cells.
“Stromal tissue associated with pancreatic tumors provides vital support for tumor growth and metastases, and our preclinical and clinical data to date suggest that connective tissue growth factor (CTGF) plays a central role in the stroma of pancreatic cancer,” said Dr.
In a previous study, increasing doses of FG-3019 were combined with gemcitabine plus erlotinib for treatment of subjects with advanced pancreatic cancer. That study (N=75) indicated a dose-related increase in survival. At the lowest doses of FG-3019, no subjects survived for one year, while at the highest doses approximately 30% of subjects survived one year. The study further demonstrated a relationship between blood levels of FG-3019 and survival.
About Pancreatic Cancer
Pancreatic ductal adenocarcinoma, or pancreatic cancer, is the fourth leading cause of cancer deaths in
FG-3019 is an investigational therapeutic antibody developed by
In desmoplastic, or fibrotic, cancers such as pancreatic cancer, CTGF in the extensive fibrous stroma associated with the tumor promotes abnormal proliferation of stromal cells and tumor cells, induces extracellular-matrix, or ECM, deposition that provides a substrate for tumor cell adherence, promotes angiogenesis, and promotes metastasis by enhancing cell motility, invasion, and survival. Studies in a transgenic mouse model of pancreatic cancer indicate that treatment with FG-3019 in combination with chemotherapy may enhance the efficacy of chemotherapy and improve survival.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the potential benefit of FG-3019 to patients with pancreatic cancer, the usefulness of tumor biopsies, the survival benefit of tumor resection, and the potential for continued safety or efficacy in this and other studies. Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the