FibroGen has announced the termination of its pamrevlumab development program following disappointing results from two critical pancreatic cancer trials, triggering a substantial corporate restructuring that will eliminate 75% of its workforce.
The dual trial failures came from the PanCAN Precision Promise study in metastatic pancreatic cancer and the LAPIS trial investigating locally advanced, unresectable pancreatic cancer. Neither study achieved its primary endpoint of improved overall survival, dealing a final blow to the first-in-class connective tissue growth factor (CTGF) inhibitor.
"We are deeply disappointed by these results, particularly given the significant unmet need in pancreatic cancer treatment," stated Thane Wettig, Chief Executive Officer of FibroGen. The setback follows pamrevlumab's previous failure in Duchenne muscular dystrophy trials last year, which had already prompted an earlier round of cost reductions.
Financial Impact and Market Response
The news triggered an immediate 46% decline in FibroGen's stock during premarket trading. However, the company maintains a relatively stable financial position with approximately $215 million in cash reserves as of March 2023. Additional revenue streams come from Evrenzo (roxadustat), their chronic kidney disease anemia treatment partnered with Astellas, which generated $56 million in Q1 revenues.
Pipeline Developments and Future Direction
Despite these setbacks, FibroGen's pipeline includes several promising candidates:
- FG-3246: A CD46-targeting antibody-drug conjugate licensed from Fortis Therapeutics, showing positive results in phase 1b trials for metastatic castration-resistant prostate cancer when combined with enzalutamide
- FG-3165: A newly FDA-approved trial candidate targeting galectin-9 for solid tumors
- FG-3175: An anti-CCR8 antibody in preclinical development
Both FG-3165 and FG-3175 will be evaluated in combination with Regeneron's PD-1 inhibitor Libtayo (cemiplimab) under a recent partnership agreement.
The company faces additional challenges with its marketed product Evrenzo, as former partner AstraZeneca recently returned rights to the drug following its failure to secure FDA approval in the United States.
