FibroGen has announced that two late-stage trials of pamrevlumab for pancreatic cancer failed to meet primary endpoints, prompting the termination of the program and a 75% workforce reduction in the U.S.
The trials, sponsored by the Pancreatic Cancer Action Network (PanCAN) and FibroGen, did not show a statistically significant improvement in overall survival rates. The phase 2/3 Precision Promise trial targeted metastatic pancreatic ductal adenocarcinoma (mPDAC), while the phase 3 LAPIS trial focused on locally advanced, unresectable pancreatic cancer (LAPC). Both trials compared pamrevlumab combined with standard chemotherapy to chemotherapy alone.
Following the results, FibroGen will terminate its pamrevlumab R&D program. The company plans to wind down remaining obligations related to the drug.
FibroGen will continue advancing roxadustat, an oral treatment for anemia in chronic kidney disease (CKD), through global phase 3 trials. It is approved for CKD-related anemia in China, Europe, Japan, and other countries, with more applications under review. The drug faced regulatory challenges in the U.S., including data modification issues and an FDA advisory committee vote against its approval, resulting in a complete response letter for its NDA in August 2021.
Earlier this year, FibroGen and AstraZeneca ended their collaboration focused on developing and commercializing roxadustat outside of China. Under the new agreement, AstraZeneca will return all rights to FibroGen except for South Korea, while their collaboration in China remains unaffected.
