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|FibroGen Announces Publication of Pamrevlumab (FG-3019) Clinical Data in Pancreatic Cancer Showing Safety and Improved Survival Outcomes in Combination with Chemotherapy|
“The data showing improved survival with pamrevlumab suggest a role for CTGF in the interactions of cancer cells and stroma responsible for tumor proliferation in PDAC,” said
In the 028 trial, the safety and efficacy of increasing doses of pamrevlumab were evaluated in combination with two chemotherapy agents, gemcitabine and erlotinib, in 75 patients with previously untreated Stage III or Stage IV pancreatic ductal adenocarcinoma. Pamrevlumab was well tolerated with no dose-limiting toxicity observed and no dose-related trends observed in type or incidence of serious adverse events. Toxicity, tumor response by CA19-9 and CT scan-based RECIST criteria, progression-free survival (PFS) and overall survival (OS) were assessed. In a post-hoc analysis, FG-3019 trough plasma levels (a measure of exposure) on Day 15 (D15Cmin) and baseline CTGF levels were correlated with clinical outcomes. High FG-3019 exposure (D15 Cmin ≥150 μg/mL) was associated with improved median OS (9.0 vs 4.4 months, (D15 Cmin <150 μg/mL), p=0.024), and one-year OS rate (34.2% vs. 10.8%, respectively, p=0.026), respectively. Plasma CTGF showed potential as a prognostic biomarker, as low baseline CTGF levels (<10 ng/mL) were associated with improved OS (10.1 vs 4.4 months (≥10 ng/mL), p=0.028).
About Pancreatic Ductal Adenocarcinoma and Connective Tissue Growth Factor
Pancreatic ductal adenocarcinoma (PDAC), or pancreatic cancer, is the fourth leading cause of cancer deaths in
Pamrevlumab (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.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the potential benefit of pamrevlumab (FG-3019) to patients with pancreatic cancer including in combination with chemotherapy agents and in future clinical studies, and the potential for pamrevlumab to demonstrate safety or efficacy, including in combination with chemotherapy agents without incremental toxicity. 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