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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

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FibroGen, Inc. (NASDAQ: FGEN) announced the completion of the pamrevlumab experimental arm in the Pancreatic Cancer Action Network's Precision PromiseSM Phase 2/3 adaptive platform trial. The topline data from this registration study is anticipated in the second quarter of 2024. Pamrevlumab achieved a protocol pre-specified ≥ 35% predictive probability of success for the primary endpoint of overall survival at the completion of the trial and graduated to the second and final stage of the trial in the third quarter of 2022. This marks a significant milestone in potential new therapy for patients with metastatic pancreatic cancer.
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The advancement of pamrevlumab into the latter stages of clinical testing is a significant development in the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC), a particularly aggressive form of cancer with poor prognosis. Current standard treatments, such as gemcitabine and nab-paclitaxel, offer limited efficacy for many patients, highlighting the urgent need for new therapeutic options. The fact that pamrevlumab has met the pre-specified predictive probability of success suggests that it may improve overall survival, an outcome that is critically important in oncology. If the topline data confirms these early indications of efficacy, pamrevlumab could represent a breakthrough in mPDAC treatment, potentially leading to increased demand for FibroGen's product, altering treatment protocols and impacting the company's market position and valuation.

The progress of pamrevlumab through clinical trials is a key driver of investor interest in FibroGen, particularly as the market for pancreatic cancer treatments remains underserved. Given the high unmet medical need and the potential market exclusivity that comes with breakthrough therapies, positive topline data could lead to significant revenue opportunities for FibroGen. Investors will be closely monitoring the upcoming topline data release in 2Q 2024, as it will provide critical insights into the drug's commercial potential and likely impact on FibroGen's stock performance. Furthermore, the successful progression of pamrevlumab may attract partnership opportunities or even make FibroGen a potential acquisition target, given the high stakes in the oncology pharmaceutical market.

The design of the Precision PromiseSM Phase 2/3 adaptive platform trial is particularly noteworthy. Adaptive trials are designed to be more efficient than traditional clinical trials, allowing for modifications to the trial and treatment arms based on accumulating data. This can lead to faster decision-making and potentially accelerated drug development timelines. Pamrevlumab's progression within this adaptive trial framework suggests that the drug is showing promise early on, which can be a positive indicator for its future success. However, it is important to remain cautious until the full dataset is available, as early graduation does not guarantee regulatory approval or clinical success. The long-term impact on FibroGen will depend on the robustness of the topline data, subsequent regulatory interactions and the ability to successfully bring the drug to market.

  • 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 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). 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-specified35% 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-specified35% 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.

About FibroGen
FibroGen, Inc. is a biopharmaceutical company focused on accelerating the development of novel therapies at the frontiers of cancer biology. Pamrevlumab, an anti-CTGF fully human monoclonal antibody, is in clinical development for the treatment of metastatic pancreatic cancer and locally advanced unresectable pancreatic cancer (LAPC). Roxadustat (爱瑞卓®, EVRENZOTM) is currently approved in China, Europe, Japan, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. Roxadustat is in clinical development for chemotherapy-induced anemia (CIA) and a Supplemental New Drug Application (sNDA) has been accepted for review by the China Health Authority. FibroGen recently expanded its research and development portfolio to include antibody-drug conjugate (ADC) and immunoncology product candidates for the treatment of solid tumors. For more information, please visit www.fibrogen.com.

Forward-Looking Statements
This release contains forward-looking statements regarding FibroGen’s strategy, future plans and prospects, including statements regarding the company’s financial performance, the development and commercialization of the company’s product candidates, the potential safety and efficacy profile of its product candidates, and its clinical programs and those of its partner, PanCAN. These forward-looking statements include, but are not limited to, statements regarding the potential and probability of success of FibroGen product candidates, and statements about FibroGen’s plans and objectives and typically are identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. FibroGen’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in FibroGen’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, and our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and FibroGen undertakes no obligation to update any forward-looking statement in this press release, except as required by law.

References:

1. American Cancer Society. Cancer Facts & Figures 2021. Atlanta: American Cancer Society; 2021. 

FibroGen, Inc.
Investors:
David DeLucia, CFA
Vice President of Corporate FP&A / Investor Relations
ir@fibrogen.com

Media:
Meichiel Keenan
Director, Investor Relations and Corporate Communications
media@fibrogen.com


FAQ

What is the status of the pamrevlumab experimental arm in the Precision PromiseSM Phase 2/3 adaptive platform trial?

The pamrevlumab arm of the study completed Stage 2 of the trial in January 2024.

When is the topline data from the registration study anticipated?

The topline data from this registration study is anticipated in the second quarter of 2024.

What is the ticker symbol for FibroGen, Inc.?

The ticker symbol for FibroGen, Inc. is FGEN.

FibroGen, Inc.

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About FGEN

fibrogen is a research-based biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics to treat serious unmet medical needs. the company has built upon its extensive research experience in fibrosis and hypoxia-inducible factor (hif) biology to generate clinical programs targeting multiple therapeutic areas. fibrogen's most advanced product candidate, roxadustat (fg-4592), is an oral small molecule inhibitor of hif prolyl hydroxylases (hif-phs), in phase 3 clinical development for the treatment of anemia in chronic kidney disease (ckd). our second product candidate, fg-3019, is a monoclonal antibody in phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (ipf), pancreatic cancer and liver fibrosis. for more information please visit: www.fibrogen.com.