FibroGen Completes Pancreatic Cancer Trial Phase for Pamrevlumab

FibroGen, Inc. has announced a significant development in the clinical trial of pamrevlumab, a drug developed to combat metastatic pancreatic ductal adenocarcinoma (mPDAC). The company has successfully completed the second stage of the Pancreatic Cancer Action Network's Precision PromiseSM Phase 2/3 adaptive platform trial, which combines pamrevlumab with chemotherapy drugs gemcitabine and nab-paclitaxel. This achievement is particularly notable as pamrevlumab is the first to reach the necessary threshold for progression to the second stage of the trial.

The trial, which is expected to deliver its primary data in the second quarter of 2024, aims to provide a new treatment option for mPDAC patients who currently have limited therapeutic choices. Thane Wettig, CEO of FibroGen, expressed excitement about the milestone, stating that it brings a potential new therapy closer for a population in need. The company is eager to collaborate with PanCAN to share the upcoming data, which could lead to a new treatment option for pancreatic cancer.

Julie Fleshman, President and CEO of PanCAN, also expressed enthusiasm for the trial's progress and the potential it holds for improving patient outcomes. The Precision PromiseSM trial is a U.S.-based study involving approximately 24 sites and has enrolled patients to receive either first-line or second-line treatment options. The study is designed to evaluate the effectiveness of pamrevlumab in conjunction with standard chemotherapy, with the primary endpoint being overall survival.

Pamrevlumab is a novel antibody that targets the connective tissue growth factor (CTGF), and it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of pancreatic ductal adenocarcinoma (PDAC). It is also under investigation for the treatment of locally advanced unresectable pancreatic cancer (LAPC). The drug has shown a favorable safety and tolerability profile, supporting its ongoing clinical investigation.

FibroGen, Inc. is a biopharmaceutical company dedicated to advancing innovative therapies in cancer biology. In addition to pamrevlumab, the company has a portfolio that includes other drug candidates for solid tumors and anemia treatment in chronic kidney disease patients.

The metastatic pancreatic cancer landscape is challenging, with over 30,000 new cases diagnosed annually in the U.S. and a five-year survival rate of only 3 percent. Current treatments are limited, making the potential of a new therapy like pamrevlumab particularly significant for improving patient outcomes.

The Precision PromiseSM trial's statistical design, led by Dr. Donald Berry, is based on Bayesian principles and has been discussed with the FDA. The study's comprehensive approach includes not only primary endpoints but also secondary endpoints such as progression-free survival, objective response rate, and duration of response. Genomic data collection is also part of the trial to provide deeper insights into treatment impacts.

The announcement by FibroGen highlights the importance of ongoing research and development in the field of oncology, as well as the potential for new therapies to make a significant difference in the lives of patients with mPDAC. The upcoming data release is eagerly anticipated by both the scientific community and patients alike.