TIDMHCM
Hutchmed (China) Limited
04 April 2023
Press Release
HUTCHMED Initiates Registration Phase Enrollments of HMPL-453
for IHCC and Savolitinib for Gastric Cancer following NMPA
Consultations
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, April 4,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has consulted the China National
Medical Products Administration ("NMPA") and reached an agreement
to initiate the registration phase of the ongoing Phase II trial of
HMPL-453 for intrahepatic cholangiocarcinoma ("IHCC") patients with
fibroblast growth factor receptors ("FGFR") 2 fusion. If positive,
the data from the registration phase may be used to support a
future New Drug Application ("NDA") filing. The first patient
received their first dose in March 2023.
In addition, it also reached an agreement to initiate the
registration phase of the ongoing Phase II trial of savolitinib for
gastric cancer patients with mesenchymal-epithelial transition
("MET") amplification following NMPA consultation. If positive, the
data from the registration phase may be used to support a future
NDA filing. The first patient also received their first dose in
March 2023.
The study of HMPL-453 is a single-arm, multi-center, open-label,
Phase II registration study to evaluate the efficacy, safety and
pharmacokinetic of HMPL-453 in treating advanced IHCC patients with
FGFR2 fusion. Primary endpoint is objective response rate ("ORR").
Secondary endpoints include progression-free survival ("PFS"),
disease control rate (DCR), duration of response (DoR) and overall
survival (OS). The study is expected to enroll approximately 90
additional patients. Additional details may be found at
clinicaltrials.gov using identifier NCT04353375.
The study of savolitinib is a single-arm, multi-center,
open-label, Phase II registration study to evaluate the efficacy,
safety and tolerability of savolitinib in treating gastric cancer
and esophagogastric junction adenocarcinoma patients with MET
amplification. Primary endpoint is ORR evaluated by the Independent
Review Committee (IRC) (RECIST 1.1). Secondary endpoints include
PFS and incidence of various adverse events (AE). The study is
expected to enroll approximately 60 additional patients. Further
details may be found at clinicaltrials.gov using identifier
NCT04923932.
About HMPL--453
HMPL--453 is a novel, highly selective and potent inhibitor
targeting FGFR 1, 2 and 3. Aberrant FGFR signaling has been found
to be a driving force in tumor growth (through tissue growth and
repair), promotion of angiogenesis and resistance to anti-tumor
therapies. Abnormal FGFR gene alterations are believed to be the
drivers of tumor cell proliferation in several solid tumor
settings.
HUTCHMED currently retain all rights to HMPL-453 worldwide.
About IHCC with FGFR2 Fusion
IHCC is one of the subtypes of primary liver cancer. In China,
an estimated 61,900 newly diagnosed IHCC occurred in 2015 and the
overall IHCC incidence increased by 9.2% per year between 2006 and
2015. [1] FGFR2 fusion has been reported to have a prevalence of
10-15% in IHCC patients.[2] [3]
About savolitinib
Savolitinib is an oral, potent and highly selective MET tyrosine
kinase inhibitor that has demonstrated clinical activity in
advanced solid tumors. It blocks atypical activation of the MET
receptor tyrosine kinase pathway that occurs because of mutations
(such as exon 14 skipping alterations or other point mutations),
gene amplification or protein overexpression.
Savolitinib is marketed in China under the brand name
ORPATHYS(R) for the treatment of patients with non-small cell lung
cancer ("NSCLC") with MET exon 14 skipping alterations who have
progressed following prior systemic therapy or are unable to
receive chemotherapy. It is currently under clinical development
for multiple tumor types, including lung, kidney and gastric
cancers, as a single treatment and in combination with other
medicines. Starting on March 1, 2023, ORPATHYS(R) was included in
the National Reimbursement Drug List (NRDL) for the treatment of
locally advanced or metastatic NSCLC adult patients with MET exon
14-skipping alterations who have progressed after or unable to
tolerate platinum-based chemotherapy.
In 2011, AstraZeneca and HUTCHMED entered a global licensing and
collaboration agreement to jointly develop and commercialize
savolitinib. Joint development of savolitinib in China is led by
HUTCHMED, while AstraZeneca leads development outside of China.
HUTCHMED is responsible for the marketing authorization,
manufacturing and supply of savolitinib in China. AstraZeneca is
responsible for the commercialization of savolitinib in China and
worldwide. Sales of savolitinib are recognized by AstraZeneca.
About Gastric Cancer with MET Amplification
MET-driven gastric cancer has a very poor prognosis.[4] The
ongoing registration trial follows multiple Phase II studies that
have been conducted in Asia to study ORPATHYS(R) in MET-driven
gastric cancer patients, including VIKTORY.(3) VIKTORY is an
investigator initiated Phase II umbrella study in gastric cancer in
South Korea in which a total of 715 patients were successfully
sequenced into molecular-driven patient groups, including those
with MET amplified gastric cancer. Patients whose tumors harbor MET
amplification were treated with ORPATHYS(R) monotherapy.
It is estimated that MET amplification accounts for
approximately 4-6% of gastric cancer patients.[5](,[6]) The annual
incidence of MET amplification gastric cancer is estimated to be
approximately 24,000 in China.[7]
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative,
commercial-stage, biopharma-ceutical company. It is committed to
the discovery and global develop-ment and commercial-ization of
targeted therapies and immuno-therapies for the treatment of cancer
and immuno-logical diseases. It has more than 5,000 personnel
across all its companies, at the center of which is a team of about
1,800 in oncology/immunology. Since inception it has focused on
bringing cancer drug candidates from in-house discovery to patients
around the world, with its first three oncology drugs now approved
and marketed in China. For more information, please visit:
www.hutch-med.com or follow us on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the "safe harbor" provisions of the U.S. Private
Securities Litigation Reform Act of 1995. These forward-looking
statements reflect HUTCHMED's current expectations regarding future
events, includ-ing its expectations regarding the thera-peutic
potential of savolitinib and HMPL-453, the further clinical
develop-ment for savolitinib and HMPL-453, its expectations as to
whether any studies on savolitinib and HMPL-453 would meet their
primary or secondary endpoints, and its expectations as to the
timing of the completion and the release of results from such
studies. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding enrollment rates and the timing and
availability of subjects meeting a study's inclusion and exclusion
criteria; changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of
savolitinib and HMPL-453, including as a combination therapy, to
meet the primary or secondary endpoint of a study, to obtain
regulatory approval in different jurisdictions and to gain
commercial acceptance after obtaining regulatory approval; the
potential market of savolitinib and HMPL-453 for a targeted
indication; the sufficiency of funding; and the impact of the
COVID-19 pandemic on general economic, regulatory and political
conditions. Existing and prospective investors are cautioned not to
place undue reliance on these forward-looking statements, which
speak only as of the date hereof. For further discussion of these
and other risks, see HUTCHMED's filings with the U.S. Securities
and Exchange Commission, The Stock Exchange of Hong Kong Limited
and on AIM. HUTCHMED undertakes no obligation to update or revise
the information contained in this press release, whether as a
result of new information, future events or circumstances or
otherwise.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055
FTI Consulting (Mobile)
HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley, Panmure Gordon +44 (20) 7886 2500
[1] An L, Zheng R, Zhang S, et al. Hepatocellular carcinoma and
intrahepatic cholangiocarcinoma incidence between 2006 and 2015 in
China: estimates based on data from 188 population-based cancer
registries. Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):45-55. .
[2] Arai Y, Totoki Y, Hosoda F, Shirota T, Hama N, Nakamura H,
et al. Fibroblast growth factor receptor 2 tyrosine kinase fusions
define a unique molecular subtype of cholangiocarcinoma.
Hepatology. 2014;59:1427-34.
[3] Nakamura H, Arai Y, Totoki Y, Shirota T, Elzawahry A, Kato
M, et al. Genomic spectra of biliary tract cancer. Nat Genet.
2015;47:1003-10.
[4] Catenacci DV, Ang A, Liao WL, et al. MET tyrosine kinase
receptor expression and amplification as prognostic biomarkers of
survival in gastroesophageal adenocarcinoma. Cancer.
2017;123(6):1061-1070. doi:10.1002/cncr.30437
[5] Lee J, Kim ST, Kim K, et al. Tumor Genomic Profiling Guides
Patients with Metastatic Gastric Cancer to Targeted Treatment: The
VIKTORY Umbrella Trial. Cancer Discov. 2019;9(10):1388-1405.
doi:10.1158/2159-8290.CD-19-044
[6] Van Cutsem E, Karaszewska B, Kang YK, et al. A Multicenter
Phase II Study of AMG 337 in Patients with MET-Amplified
Gastric/Gastroesophageal Junction/Esophageal Adenocarcinoma and
Other MET-Amplified Solid Tumors. Clin Cancer Res.
2019;25(8):2414-2423. doi:10.1158/1078-0432.CCR-18-1337
[7] Global Cancer Observatory. China Fact Sheet.
gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed March 20, 2023.
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END
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