FibroGen Reports Results from Two Pamrevlumab Pancreatic Cancer Studies and Provides Update

FibroGen, Inc. has released results from two advanced-stage trials assessing pamrevlumab's efficacy and safety in pancreatic cancer patients. The trials, which spanned metastatic and locally advanced unresectable pancreatic cancer, did not meet their primary objective of enhancing overall survival.

In the Precision Promise Phase 2/3 adaptive platform trial by PanCAN, the efficacy of pamrevlumab combined with gemcitabine and nab-paclitaxel was compared to the same chemotherapy regimen without pamrevlumab in both first-line (1L) and second-line (2L) treatments for metastatic pancreatic ductal adenocarcinoma (mPDAC). This study, which used a Bayesian statistical analysis, failed to reach the predetermined primary endpoint of improving overall survival.

Similarly, the LAPIS Phase 3 trial evaluated pamrevlumab combined with either gemcitabine and nab-paclitaxel or FOLFIRINOX against a placebo with the same chemotherapy combinations in patients with locally advanced, unresectable pancreatic cancer (LAPC). The trial did not achieve its primary goal of overall survival improvement.

Thane Wettig, CEO of FibroGen, expressed deep disappointment over these outcomes, highlighting the significant efforts and hopes invested in pamrevlumab’s potential. Wettig thanked the patients, their families, and the clinical trial teams for their participation and dedication. He also acknowledged the commitment of FibroGen employees who worked tirelessly on these projects.

As a consequence of these findings, FibroGen will implement an immediate and substantial cost reduction strategy in the U.S. This will involve terminating the R&D investment in pamrevlumab and swiftly winding down remaining obligations. The plan includes a significant reduction of approximately 75% in the U.S. workforce.

Despite the setbacks with pamrevlumab, FibroGen's other collaborations and projects remain unaffected. Their agreement with AstraZeneca for roxadustat in China, where it leads the market in the CKD anemia category, and their collaboration with Astellas for roxadustat in Europe, Japan, and other regions continue as planned.

For the Precision Promise trial, the primary overall survival (OS) analysis assumed a common hazard ratio to estimate the treatment effect for both 1L and 2L pamrevlumab patients compared to those treated with gemcitabine and nab-paclitaxel alone. The Bayesian model used in the study incorporated data from the mFOLFIRINOX control group to the gemcitabine and nab-paclitaxel control group for primary efficacy analysis. The mITT population for the pamrevlumab arm included 102 patients in the 1L group and 111 patients in the 2L group, while the control arm comprised 34 1L patients and 36 2L patients.

The LAPIS trial’s primary endpoint of overall survival also did not show significant improvement, with median survival times of 17.3 months for the pamrevlumab combination group versus 17.9 months for the control group. The safety profile for pamrevlumab in combination with the chemotherapy regimens was generally acceptable, showing no clinically meaningful differences in adverse events between treatment arms.

Pamrevlumab, developed by FibroGen, is a fully human monoclonal antibody targeting connective tissue growth factor (CTGF). It has received Orphan Drug Designation and Fast Track designation from the FDA for treating pancreatic ductal adenocarcinoma and LAPC, respectively. However, it remains an investigational drug not approved for marketing by any regulatory authority.

FibroGen, a biopharmaceutical company, focuses on developing innovative therapies, particularly in cancer biology. Their other products, like roxadustat for anemia in chronic kidney disease, have seen approval in several countries, including China, Europe, and Japan. Additionally, their portfolio includes FG-3246 for metastatic castration-resistant prostate cancer and two immuno-oncology candidates for solid tumors.

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