FibroGen Cuts 75% of Workforce After Lead Cancer Therapy Fails Phase III

FibroGen has faced a significant setback with its leading oncology candidate, pamrevlumab, as two Phase III trials failed to achieve their primary objectives. These trials were investigating the effectiveness of pamrevlumab in treating pancreatic cancer. As a result, the company has decided to halt the development of pamrevlumab and will lay off 75% of its workforce in the United States. Following this news, FibroGen's stock plummeted by around 40% in premarket trading.

In the Phase III LAPIS trial (NCT03941093), the combination of pamrevlumab and chemotherapy did not meet the primary endpoint of overall survival in patients with locally advanced, inoperable pancreatic cancer. Similarly, in the Phase II/III PanCAN’s Precision Promise trial (NCT04229004), the same treatment regimen failed to achieve the primary endpoint of overall survival in patients with metastatic pancreatic ductal adenocarcinoma.

FibroGen has not found any late-stage clinical success with pamrevlumab. The drug was also ineffective in treating Duchenne muscular dystrophy (DMD), with the company announcing last year that two Phase III trials in DMD patients did not meet their primary endpoints. Pamrevlumab works as a monoclonal antibody that inhibits connective tissue growth factor (CTGF), a protein involved in the development of various tumors and tissue fibrosis.

Despite the setbacks with pamrevlumab, FibroGen continues to maintain its commercial agreements for the anemia therapy roxadustat. Astellas holds the development and commercialization rights to roxadustat in regions including Japan, Europe, Turkey, Russia, the Commonwealth of Independent States, the Middle East, and South Africa. In China and South Korea, AstraZeneca has the commercial rights to roxadustat, marketed under the brand name Evrenzo. FibroGen anticipates a decision on the approval of roxadustat for chemotherapy-induced anemia (CIA) in China in the second half of 2024, which could potentially result in a $10 million milestone payment from AstraZeneca if the decision is favorable.

Additionally, FibroGen's oncology pipeline includes FG-3246, a CD-46 targeting antibody-drug conjugate (ADC). The company licensed this therapy from Fortis Therapeutics in May 2023. In April, FibroGen reported positive data from a Fortis-sponsored Phase I trial (NCT03575819) involving metastatic castration-resistant prostate cancer patients. The study showed a median progression-free survival of 8.7 months and a significant reduction in prostate-specific antigen levels in 36% of participants, indicating the potential effectiveness of FG-3246.

While FibroGen winds down its research and development activities for pamrevlumab, the future of the company’s other therapies remains hopeful. The commercialization of roxadustat continues to hold promise, and the initial positive results from the FG-3246 trial suggest potential new avenues for FibroGen in oncology treatment.

In summary, FibroGen has experienced a major disappointment with the failure of pamrevlumab in late-stage trials, prompting cost-cutting measures and workforce reductions. Nevertheless, the company remains engaged in other promising areas, including the continued commercialization of roxadustat and the development of FG-3246, suggesting that FibroGen's overall trajectory in the pharmaceutical industry still holds potential.

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