HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer
29 August 2023 - 10:00AM
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® 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.
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. 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 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 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 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 9783 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.304372 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-19-0443 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-18-13374 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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