FibroGen's Pamrevlumab Phase Complete in Pancreatic Cancer Adaptive Trial

FibroGen, Inc., a biopharmaceutical firm, has reported that its drug candidate, pamrevlumab, has successfully completed the second phase of a pivotal clinical trial. The trial, known as the Pancreatic Cancer Action Network's Precision PromiseSM Phase 2/3 adaptive platform trial, is assessing the efficacy of pamrevlumab when combined with chemotherapy drugs gemcitabine and nab-paclitaxel for the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The company anticipates releasing the primary data from this study in the second quarter of 2024.

In the initial phase of the trial, pamrevlumab demonstrated a predictive probability of success for overall survival that met the trial's protocol-specified threshold of at least 35%, which qualified it to advance to the second phase. The study's completion in January 2024 marks a significant step forward in the development of a potential new treatment for mPDAC, a disease for which there are currently limited therapeutic options.

FibroGen's CEO, Thane Wettig, expressed excitement about the milestone, highlighting the potential of pamrevlumab to offer a new therapy for metastatic pancreatic cancer patients. The Pancreatic Cancer Action Network (PanCAN) also expressed enthusiasm about the progress of the pamrevlumab arm in the Precision PromiseSM study, looking forward to the final results that could pave the way for a new treatment option.

The Precision PromiseSM trial is a multi-arm study conducted across approximately 24 sites in the U.S., with pamrevlumab being offered as a first-line or second-line treatment option for mPDAC patients. The study's statistical design, led by Dr. Donald Berry, is based on Bayesian principles and has been discussed with the FDA. Secondary endpoints of the trial include progression-free survival, objective response rate, and duration of response, which will provide a comprehensive assessment of the treatment's impact.

Pamrevlumab is a first-in-class antibody developed by FibroGen to target the activity of connective tissue growth factor (CTGF). It is currently in clinical development for the treatment of mPDAC and locally advanced unresectable pancreatic cancer (LAPC). The drug has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of pancreatic ductal adenocarcinoma (PDAC) and Fast Track designation for LAPC treatment.

FibroGen is dedicated to advancing novel therapies in cancer biology. In addition to pamrevlumab, the company's portfolio includes Roxadustat, which is approved in several countries for treating anemia in chronic kidney disease patients. FibroGen is also expanding into antibody-drug conjugates and immunoncology product candidates for solid tumors.

Metastatic pancreatic cancer is a severe condition with over 30,000 new diagnoses in the U.S. each year and a five-year survival rate of only 3 percent. At this stage, the cancer has spread, making surgical removal impossible, and treatment relies on systemic chemotherapy to reach cancer cells throughout the body. The development of new treatments like pamrevlumab is crucial for improving outcomes for these patients.