TIDMHCM
Hutchmed (China) Limited
29 August 2023
Press Release
HUTCHMED Receives Breakthrough Therapy Designation in China for
Savolitinib for Gastric Cancer
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, August 29,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) today announces that the Center for Drug Evaluation of China's
National Medical Products Administration ("NMPA") has granted
Breakthrough Therapy Designation ("BTD") to savolitinib for the
treatment of locally advanced or metastatic gastric cancer or
gastroesophageal junction ("GEJ") adenocarcinoma patients with
mesenchymal epithelial transition factor ("MET") amplification who
have failed at least two lines of standard therapies.
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
or 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. The study is expected to
enroll approximately 60 patients. Further details may be found at
clinicaltrials.gov using identifier NCT04923932.
About Breakthrough Therapy Designation in China
NMPA grants BTD to new drugs that treat life-threatening
diseases or serious conditions for which there are no effective
treatment options, and where clinical evidence demonstrates
significant advantages over existing therapies. Drug candidates
with BTD may be considered for conditional approval and priority
review when submitting a New Drug Application ("NDA"). This
indicates that the development and review of the therapy for this
disease indication may be expedited, to address patients' unmet
needs more quickly.
About Gastric Cancer with MET Amplification
MET-driven gastric cancer has a very poor prognosis. [1] 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. The
VIKTORY study reported a 50% ORR.
At American Association for Cancer Research Annual Meeting 2023
(AACR 2023), it was reported that the interim results from a China
Phase II study of savolitinib in patients with MET-amplified GEJ
adenocarcinomas or gastric cancer showed a 45% ORR confirmed by IRC
and a 50% ORR in patients with high MET gene copy number. Duration
of response (DOR) rate at 4-month was 85.7% with median follow up
time of 5.5 months. The most common grade>=3 treatment-related
adverse events ("TRAE") (>=5%) were platelet count decreased,
hypersensitivity, anemia, neutropenia and hepatic function
abnormal. Only 1 patient discontinued treatment due to grade 4
liver function abnormal (TRAE) and no patient died due to TRAE.
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 24,000 in China. [4]
About Savolitinib
Savolitinib is an oral, potent and highly selective MET tyrosine
kinase inhibitor that has demonstrated clinical activity in
advanced solid tumors. t 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. t 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.
n 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 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. It has approximately 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, including its expectations regarding the therapeutic
potential of savolitinib for the treatment of gastric cancer and
the further clinical development of savolitinib in this and other
indications. Forward-looking statements involve risks and
uncertainties. Such risks and uncertainties include, among other
things, assumptions regarding the sufficiency of clinical data to
support NDA approval of savolitinib for the treatment of gastric
cancer in China, the U.S., Europe, Japan, Australia or other
jurisdictions, its potential to gain expeditious approvals from
regulatory authorities, the safety profile of savolitinib,
HUTCHMED's ability to fund, implement and complete its further
clinical development and commercialization plans for savolitinib,
the timing of these events, and the impact of COVID-19 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, on AIM and on The Stock Exchange of Hong Kong Limited.
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
Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile) / HUTCHMED@fticonsulting.com
Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
[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.
gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
Accessed March 20, 2023.
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