FibroGen Announces Completion of the Pamrevlumab Arm in Precision Promise, Pancreatic Cancer Action Network’s Phase 2/3 Adaptive Platform Trial for Metastatic Pancreatic Cancer

• Pamrevlumab has now completed Stage 2 of the trial and topline data from this registration study in ~175 pamrevlumab treated patients is anticipated in 2Q 2024
  
  
• Pamrevlumab is the first experimental arm to meet its required threshold for graduation in the seamless Phase 2/3 adaptive platform trial
  
  

SAN FRANCISCO, Jan. 25, 2024 (GLOBE NEWSWIRE) -- FibroGen, Inc. (NASDAQ: FGEN) announced graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network's (PanCAN) Precision Promise^SM Phase 2/3 adaptive platform trial, which evaluates pamrevlumab in combination with the chemotherapy treatments gemcitabine and nab-paclitaxel for patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). Topline data from this registration study is anticipated in the second quarter of 2024.

Pamrevlumab, in Stage 1 of the trial, achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial, and thus graduated to the second and final Stage of the trial in the third quarter of 2022. Pamrevlumab is the first experimental arm to meet its required threshold for graduation to Stage 2 in the adaptive platform trial. The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024.

“We are excited to announce the achievement of this significant milestone in Precision Promise^SM. The graduation and completion of the pamrevlumab arm of this study brings a potential new therapy one step closer for patients with metastatic pancreatic cancer, an underserved population with limited treatment options,” said Thane Wettig, Chief Executive Officer, FibroGen. “We look forward to continuing to work with PanCAN in sharing the topline data in the coming months.”

“We are enthusiastic about the graduation and completion of the pamrevlumab investigational arm in Precision Promise^SM and look forward to seeing the final study results, which could potentially lead to a new treatment option for pancreatic cancer patients,” said Julie Fleshman, JD, MBA, President and CEO of PanCAN.

PanCAN’s Precision Promise^SM adaptive platform trial (NCT04229004) is a U.S.-based, seamless Phase 2/3 study that enrolled patients in approximately 24 sites around the country. The multi-arm study consists of experimental treatment arms and two comparator arms: gemcitabine + nab-paclitaxel and mFOLFIRINOX. The pamrevlumab experimental arm was offered to patients with mPDAC as either a first-line (1L) or second-line (2L) treatment option. In the initial stage of the study (Stage 1), at least 100 patients with mPDAC received pamrevlumab in combination with gemcitabine and nab-paclitaxel. Guided by Bayesian principles, the graduation threshold for pamrevlumab was a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial. Upon graduation, an additional 75 patients with mPDAC were enrolled (Stage 2), receiving the same pamrevlumab treatment regimen as in Stage 1. All patients are dosed until disease progression and the final analysis is based upon the data collected up to 12 months after the last patient initiates treatment in Stage 2. The combined Stage 1 and Stage 2 data will form the basis for analysis of the primary and secondary endpoints for the pamrevlumab arm. Secondary endpoints include progression-free survival (PFS), objective response rate (ORR), and duration of response (DOR), offering a comprehensive understanding of the treatment's impact. Biomarker-related data, including genomics data, have been collected to provide additional insights into the trial's outcomes. Precision Promise^SM is a registration study and the statistical design has been discussed by PanCAN with the FDA. The statistical design of Precision Promise^SM is led by renowned statistician Dr. Donald Berry of Berry Consulting.