LianBio Announces Topline Results from Phase 2a Proof of Concept Trial Evaluating Infigratinib in Patients with Gastric Cancer & Receipt of Breakthrough Therapy Designation in China
June 06 2023 - 4:05PM
LianBio (Nasdaq: LIAN), a biotechnology company dedicated to
bringing innovative medicines to patients in China and other major
Asian markets, today announced positive topline results from a
Phase 2a proof of concept trial evaluating infigratinib in Chinese
patients with locally advanced or metastatic gastric cancer or
gastroesophageal junction adenocarcinoma with fibroblast growth
factor receptor-2 (FGFR2) gene amplification.
The Phase 2a trial is a multicenter, open-label, single-arm
study in China designed to evaluate the safety and efficacy of
infigratinib 125 mg QD in patients with locally advanced or
metastatic gastric cancer or gastroesophageal junction
adenocarcinoma with FGFR2 gene amplification and other advanced
solid tumors with FGFR alterations who have received at least two
prior lines of systemic therapy. The primary endpoint is objective
response rate (ORR). Secondary endpoints include duration of
response, safety, disease control rate, progression-free survival,
and overall survival (NCT05019794).
The topline results from the gastric cancer and gastroesophageal
junction adenocarcinoma cohort demonstrated a confirmed ORR of
25.0% (n=20). The observed median duration of response (DOR) was
3.8 months. 57.1% of patients had received two prior lines of
systemic therapy, 33.3% of patients had received three prior lines
of systemic therapy, and 9.5% of patients had received more than
three prior lines of systemic therapy. The most common
treatment-emergent adverse events of any grade (greater than or
equal to 20 percent) included hyperphosphatemia, anemia, alanine
aminotransferase increase, aspartate aminotransferase increase,
white blood cell count decrease, neutrophil count decrease,
diarrhea, constipation, palmar-plantar erythrodysesthesia, lipase
increase, blood alkaline phosphatase increase, and blood bilirubin
increase.
“Gastric cancer impacts a disproportionately high number of
patients in China,” said Yizhe Wang, Ph.D., Chief Executive Officer
of LianBio. “Patients whose disease has progressed on existing
treatment options face a poor prognosis today. The topline data
from this proof-of-concept trial suggest infigratinib has the
potential to provide meaningful clinical benefit in third-line or
later gastric cancer. We look forward to further investigating the
efficacy and safety of infigratinib in this patient population in a
Phase 2 study designed to support registration in China that we
plan to initiate next year.”
Based on these data, the China National Medical Products
Administration (NMPA) granted Breakthrough Therapy Designation to
infigratinib for the treatment of gastric cancer. Breakthrough
Therapy Designation in China is designed to expedite the
development and review of investigational therapeutics for the
treatment of serious and life-threatening diseases that have
demonstrated preliminary evidence indicating advantages of the
therapy over currently available treatment options. Drugs with
Breakthrough Therapy Designation can access additional
communication channels and technical guidance from the Center for
Drug Evaluation of the NMPA in addition to potential accelerated
approval pathways.
LianBio expects to work with investigators to present detailed
results from the clinical trial at an upcoming medical meeting.
About infigratinibInfigratinib is an orally
administered, ATP-competitive, tyrosine kinase inhibitor of
fibroblast growth factor receptor (FGFR) that targets the FGFR
protein, blocking downstream activity. In clinical studies,
infigratinib demonstrated a clinically meaningful rate of tumor
shrinkage (overall response rate) and duration of response in
cholangiocarcinoma. It is currently being evaluated in clinical
studies for locally advanced or metastatic gastric cancer or
gastroesophageal junction adenocarcinoma, and other advanced solid
tumors with FGFR genomic alterations.
LianBio licensed rights from QED Therapeutics, a subsidiary of
BridgeBio Pharma, for the development and commercialization of
infigratinib for human prophylactic and therapeutic uses in all
cancer indications in Mainland China, Hong Kong, and Macau.
Infigratinib was granted Breakthrough Therapy Designation in China
for the treatment of patients with gastric cancer in 2023.
About LianBioLianBio is a cross-border
biotechnology company on a mission to bring transformative
medicines to historically underserved patients in China and other
Asian markets. Through partnerships with highly innovative
biopharmaceutical companies around the world, LianBio is advancing
a diversified portfolio of clinically validated product candidates
with the potential to drive new standards of care across
cardiovascular, oncology, ophthalmology, and inflammatory disease
indications. LianBio is establishing an international
infrastructure to position the company as a partner of choice with
a platform to provide access to China and other Asian markets. For
more information, please visit www.lianbio.com.
Cautionary Note Regarding Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
forward-looking statements. The words “expect,” “plan,”
“potential,” “will” and similar expressions are intended to
identify forward-looking statements, although not all
forward-looking statements contain these identifying words.
Forward-looking statements in this press release include, but are
not limited to, statements regarding the potential for infigratinib
to provide meaningful clinical benefit in third-line or later
gastric cancer; LianBio’s expected timeline and plans to further
investigate the safety and efficacy of infigratinib in a Phase 2
study in gastric cancer patients; LianBio’s expectations that its
Phase 2 study of infigratinib will support registration in China;
and LianBio’s expectation that it will work with investigators to
present detailed results at an upcoming medical meeting. Actual
results may differ materially from those indicated by such
forward-looking statements as a result of various important
factors, including: LianBio’s ability to successfully initiate and
conduct its planned clinical trials and complete such clinical
trials and obtain results on its expected timelines, or at all;
LianBio’s plans to leverage data generated in its partners’ global
registrational trials and clinical development programs to obtain
regulatory approval and maximize patient reach for its product
candidates; LianBio’s ability to identify new product candidates
and successfully acquire such product candidates from third
parties; competition from other biotechnology and pharmaceutical
companies; general market conditions; the impact of changing laws
and regulations and those risks and uncertainties described in
LianBio’s filings with the U.S. Securities and Exchange Commission
(SEC), including LianBio’s Annual Report on Form 10-K for the year
ended December 31, 2022 and subsequent filings with the SEC.
In addition, topline and interim data from clinical trials may
not be indicative of final results, and the results of early
clinical trials may not be indicative of the results of later
clinical trials. Moreover, nonclinical and clinical data are often
susceptible to varying interpretations and analyses, and many
companies that have believed their product candidates performed
satisfactorily in nonclinical and clinical trials have nonetheless
failed to obtain marketing approval of their products. There is a
risk that additional nonclinical and/or clinical safety studies
will be required by the NMPA or similar regulatory authorities in
other jurisdictions, or that subsequent studies will not match
results seen in prior studies. As a result, topline data should be
viewed with caution until the final data are available.
Any forward-looking statements contained in this press release
speak only as of the date hereof, and LianBio specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or otherwise.
Readers should not rely upon this information as current or
accurate after its publication date.
For investor inquiries, please contact:
Elizabeth Anderson, VP Communications and Investor
Relations E:
elizabeth.anderson@lianbio.com T: +1 646 655
8390
For media inquiries, please contact:
Josh Xu, Director of Communications
E: josh.xu@lianbio.com T: +86 136
6140 8315
Katherine Smith, Evoke Canale
E: katherine.smith@evokegroup.com
T: +1 619 849 5378
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