RCS - Hutchmed China Ltd - HUTCHMED Completes Enrollment of Phase II Study

HUTCHMED (China)Announcement

22/04/2025 07:00

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RNS Number : 6343F  Hutchmed (China) Limited  22 April 2025

Press Release

 

HUTCHMED Completes Patient Enrollment of a Phase II Registration Study of Savolitinib in Gastric Cancer in China

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, April 22, 2025: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that it has completed enrollment of the registration
phase of its Phase II trial of savolitinib in gastric cancer patients with
MET amplification.

 

This clinical trial 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 or gastroesophageal junction ("GEJ")
adenocarcinoma patients with MET amplification. Primary endpoint is objective
response rate ("ORR") evaluated by the Independent Review Committee ("IRC")
(RECIST 1.1). Secondary endpoints include progression free survival (PFS) and
incidence of various adverse events (AE), among others. A total of 64 patients
have been enrolled in the study. Further details may be found at
clinicaltrials.gov using identifier NCT04923932
(https://clinicaltrials.gov/ct2/show/NCT04923932) .

 

As reported at the American Association for Cancer Research
(https://www.abstractsonline.com/pp8/#!/10828/presentation/10376) Annual
Meeting, interim results from the study showed a 45% ORR confirmed by IRC and
a 50% ORR in patients with high MET gene copy number. 4‑month duration of
response (DOR) rate was 85.7% with median follow up time of 5.5 months. The
most common grade 3 or higher treatment-related adverse events ("TRAE") (≥
5%) were platelet count decreased, hypersensitivity, anemia, neutropenia and
hepatic function abnormal. Only one patient discontinued treatment due to
grade 4 liver function abnormal (TRAE) and no patient died due to TRAE.

 

The China's National Medical Products Administration ("NMPA") has granted
Breakthrough Therapy Designation to savolitinib for the treatment of locally
advanced or metastatic gastric cancer or GEJ adenocarcinoma patients with MET
amplification who have failed at least two lines of standard therapies. If
positive, HUTCHMED may initiate plans to apply for marketing authorization of
savolitinib for gastric cancer in China in late 2025.

 

About Gastric Cancer with MET Amplification

MET-driven gastric cancer has a very poor prognosis. 1  It is estimated that
MET amplification accounts for approximately 4-6% of gastric cancer
patients. 2 (, 3 ) The annual incidence of MET amplification gastric cancer is
estimated to be approximately 18,000 in China. 4  The ongoing registration
trial follows multiple Phase II studies conducted in Asia to study savolitinib
in MET-driven gastric cancer patients, including VIKTORY.(2) The VIKTORY study
reported a 50% ORR in patients whose tumors harbored MET amplification and
were treated with savolitinib monotherapy.

 

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET tyrosine kinase
inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and
commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an
essential role in normal cell development. 5  Savolitinib 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 approved in China and is marketed under the brand name
ORPATHYS(®) by our partner, AstraZeneca, for the treatment of adult patients
with locally advanced or metastatic non-small cell lung cancer (NSCLC) with
MET exon 14 skipping alteration, representing the first selective MET
inhibitor approved in China. It has been included
(https://www.hutch-med.com/orpathys-nrdl-inclusion/)  in the National
Reimbursement Drug List of China (NRDL) since March 2023.

 

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.

 

About HUTCHMED

HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage,
biopharmaceutical company. It is committed to the discovery and global
development and commercialization of targeted therapies and immunotherapies
for the treatment of cancer and immunological diseases. Since inception it has
focused on bringing drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the first of
which is also approved around the world including in the US, Europe and Japan.
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 US 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 therapeutic potential of savolitinib, the further clinical development
for savolitinib, its expectations as to whether any studies on savolitinib
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, 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 for a targeted indication and
the sufficiency of funding. 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 US 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.

Medical Information

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS
 Investor Enquiries                                   +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                               +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                      Nominated Advisor and Joint Broker
 Atholl Tweedie / Freddy Crossley / Rupert Dearden    +44 20 7886 2500

 HSBC                                                 Joint Broker
 Simon Alexander / Alina Vaskina / Arnav Kapoor       +44 20 7991 8888

 Cavendish                                            Joint Broker
 Geoff Nash / Nigel Birks                             +44 20 7220 0500

 

 

 1  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

 2  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

 3  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

 4  Global Cancer Observatory. China Fact Sheet.
https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf)
. Accessed April 7, 2025.

 5  Uchikawa E, et al. Structural basis of the activation of c-MET receptor.
Nat Commun. 2021;12(4074).

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