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
25 Januar 2024 - 1:00PM
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-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 CancerOver 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 PamrevlumabPamrevlumab 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, CFAVice President of Corporate FP&A / Investor
Relationsir@fibrogen.com
Media:Meichiel KeenanDirector, Investor
Relations and Corporate Communicationsmedia@fibrogen.com
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