RCS - Hutchmed China Ltd - HUTCHMED Initiates Registration Phase Enrollments

HUTCHMED (China)Announcement

04/04/2023 10:30

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RNS Number : 3138V  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 (https://www.hutch-med.com/) ") (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
(https://clinicaltrials.gov/ct2/show/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
(https://clinicaltrials.gov/ct2/show/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  (#_edn1) 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
(https://www.hutch-med.com/first-commercial-sale-of-orpathys-milestone-payment/)
in China under the brand name ORPATHYS(®) 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(®)
was included (https://www.hutch-med.com/orpathys-nrdl-inclusion/) 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(®) 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(®) 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 (https://www.hutch-med.com/)
or follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

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 (mailto:bmiles@troutgroup.com)
 Europe - Ben Atwell / Alex Shaw,                   +44 20 3727 1030 / +44 7771 913 902 (Mobile) /

FTI Consulting                                    +44 7779 545 055 (Mobile)
                                                    HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Asia - Zhou Yi,                                    +852 9783 6894 (Mobile)

Brunswick                                         HUTCHMED@brunswickgroup.com (mailto: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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