On January 25, 2024 FibroGen, Inc. (NASDAQ: FGEN) reported graduation and completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network’s (PanCAN) Precision PromiseSM 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) (Press release, FibroGen, JAN 25, 2024, View Source [SID1234639476]). Topline data from this registration study is anticipated in the second quarter of 2024.

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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 PromiseSM. 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 PromiseSM 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 PromiseSM 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 PromiseSM is a registration study and the statistical design has been discussed by PanCAN with the FDA. The statistical design of Precision PromiseSM is led by renowned statistician Dr. Donald Berry of Berry Consulting.

About Metastatic Pancreatic Cancer
Over 30,000 patients are diagnosed with metastatic pancreatic cancer each year in the U.S. alone1 for which the five-year survival rate is 3 percent1.
In metastatic, or Stage IV, pancreatic cancer, the patient’s cancer has spread to another part of the body and therefore the cancer cannot be removed by surgery. Treatment at this stage includes systemic chemotherapy that travels through the bloodstream to reach cancer cells.

About Pamrevlumab
Pamrevlumab is a potential first-in-class antibody being developed by FibroGen to inhibit the activity of connective tissue growth factor (CTGF). Pamrevlumab is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). The U.S. Food and Drug Administration has granted Orphan Drug Designation for the treatment of patients with pancreatic ductal adenocarcinoma (PDAC), and Fast Track designation to pamrevlumab for the treatment of patients with LAPC. Pamrevlumab has demonstrated a safety and tolerability profile that has supported ongoing clinical investigation in LAPC and metastatic pancreatic cancer. Pamrevlumab is an investigational drug and not approved for marketing by any regulatory authority. For information about our pamrevlumab studies please visit www.clinicaltrials.gov.