Benzinga | Jun 16, 2021 08:01AM EDT

FibroGen Announces Pamrevlumab Included In Pancreatic Cancer Action Network's Adaptive Clinical Trial Platform

FibroGen, Inc. (NASDAQ:FGEN) announced activation of an experimental arm in the Pancreatic Cancer Action Network's (PanCAN) Precision PromiseSM adaptive trial platform evaluating pamrevlumab [and standard of care] for patients with metastatic pancreatic cancer. The objective of Precision Promise is to expedite the study and approval of promising therapies for pancreatic cancer by bringing multiple stakeholders together, including academic, industry and regulatory entities.



"We are inspired by the mission of the Pancreatic Cancer Action Network and are excited to partner with them," said Mark Eisner, MD, Chief Medical Officer. "We share PanCAN's goal of accelerating the development of new treatment options for pancreatic cancer patients."

"By partnering with FibroGen to bring a first-line experimental treatment arm into Precision Promise, we are expanding options for the patients enrolling in this trial," said Anne-Marie Duliege, MD, PanCAN's Chief Medical Officer. "It is one of PanCAN's major objectives to continue to bring innovative, experimental drugs like FibroGen's pamrevlumab into this study in order to accelerate drug development and hopefully bring new therapies to market faster. Pancreatic cancer patients can't afford to wait."

The new experimental treatment arm tests FibroGen's pamrevlumab in combination with standard of care chemotherapy treatments for pancreatic cancer, gemcitabine and Abraxane(r). The combination therapy is offered to patients with metastatic pancreatic cancer as either a first- or second-line treatment option, marking the first experimental treatment arm to be offered as a first-line treatment in PanCAN's innovative Precision Promise trial. With this addition, a newly diagnosed patient enrolling in Precision Promise has the opportunity to be randomized onto an experimental therapy as their first-line treatment, and then onto another experimental therapy as their second-line treatment if they maintain eligibility while the first treatment becomes no longer effective.

PanCAN's Precision Promise aims to revolutionize the clinical development paradigm in pancreatic cancer by enabling a faster, more efficient, and patient-centric approach to developing new treatment options and improving outcomes for pancreatic cancer patients. The novel clinical trial platform requires fewer patients to understand if a potential new therapy is working and can accelerate late-stage development by up to two years. The statistical design of Precision Promise was led by renowned statistician Dr. Donald Berry of Berry Consulting, designer of the I-SPY breast cancer trials.

Precision Promise is currently open and enrolling at 15 Clinical Trial Consortium sites nationwide and PanCAN expects to add five additional sites in early 2022. For more information on the trial, please see clinical trials.gov: Precision Promise Trial