RCS - Hutchmed China Ltd - BTD in China for Savolitinib for Gastric Cancer

HUTCHMED (China)Announcement

29/08/2023 07:00

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RNS Number : 5459K  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 (https://www.hutch-med.com/) ")
(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 (https://clinicaltrials.gov/ct2/show/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  (#_edn1) 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. The VIKTORY study
reported a 50% ORR
(https://www.hutch-med.com/chi-med-highlights-publication-of-phase-ii-data-showing-promising-efficacy-for-savolitinib-in-met-amplified-gastric-cancers/)
.

 

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  (#_edn2) (, 3  (#_edn3) ) The annual incidence of
MET amplification gastric cancer is estimated to be approximately 24,000 in
China. 4  (#_edn4)

 

About Savolitinib

Savolitinib is an oral, potent and highly selective MET tyrosine kinase
inhibitor that has demonstrated clinical activity in advanced solid tumors.
Іt 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. Іt 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.

 

Іn 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
(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, 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
                                                                   (mailto:HUTCHMED@fticonsulting.com)
    Zhou Yi, Brunswick                                             +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

 1  (#_ednref1) 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  (#_ednref2) 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  (#_ednref3) 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  (#_ednref4) 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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