TIDMHCM
Hutchmed (China) Limited
12 September 2023
Press Release
HUTCHMED Highlights Presentation of Results from the Phase IIIb
Trial of Savolitinib at the 2023 World Conference of Lung
Cancer
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, September
12, 2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM,
HKEX: 13) today announces that results from the confirmatory Phase
IIIb clinical trial of savolitinib in patients with mesenchymal
epithelial transition factor ("MET") exon 14 skipping alteration
non-small cell lung cancer ("NSCLC"), were presented during the
IASLC 2023 World Conference on Lung Cancer hosted by the
International Association for the Study of Lung Cancer ("WCLC"),
which took place from September 9 to 12, 2023 in Singapore.
Title: A Phase 3b Study of 1L Savolitinib in Patients with Locally Advanced or Metastatic NSCLC Harboring
MET Exon 14 Mutation
Lead Author: Shun Lu, MD, head of Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai Jiaotong
University
Type: Oral presentation
Abstract Number: OA21.03
Session: OA21. MET Matters in NSCLC
Date & Time: Tuesday, September 12, 2023, 2:32-2:42 pm Singapore time
Location: Room 406, Suntec Singapore Convention & Exhibition Centre
Abstract Link: https://cattendee.abstractsonline.com/meeting/10925/presentation/995
Here we reported initial efficacy and safety data from the
first-line cohort of a confirmatory Phase IIIb trial conducted in
China of savolitinib as a monotherapy in patients with NSCLC MET
exon 14 skipping alterations (NCT04923945). At data cut-off date of
April 30, 2023, among the 84 patients in the tumor response
evaluable set (TRES), objective response rate (ORR) was 60.7% (95%
Confidence Interval ("CI"): 49.5% to 71.2%) and disease control
rate (DCR) was 95.2% (95% CI: 88.3% to 98.7%), as assessed by an
independent review committee. At median follow-up of 11.1 months,
median progression free survival (mPFS) was 13.8 months (95% CI:
9.7 months to not reached). Median duration of response (DoR) and
overall survival (OS) have not been reached. No new safety signals
were observed.
The other cohort of this confirmatory trial was fully enrolled
in H1 2023 and included patients who received prior treatments. The
trial follows the June 2021 approval of savolitinib as a
monotherapy in this indication from China's National Medical
Products Administration (NMPA), which was based on positive results
from a Phase II trial (NCT02897479). This confirmatory trial
enrolled a more representative proportion of the different NSCLC
subtypes, which may confer different prognostic outcomes.
More than a third of the world's lung cancer patients are in
China and, among those with NSCLC globally, approximately 2-3% have
tumors with MET exon 14 skipping alterations. Savolitinib was
launched and is marketed under the brand name ORPATHYS(R) by our
partner, AstraZeneca for this patient population, representing the
first selective MET inhibitor approved in China.
Title: Computational Pathology-Based Assessment of cMET IHC Expression for Patient Selection in the
Treatment of MET Overexpressing NSCLC
Lead Author: Simon Christ, AstraZeneca
Type: E-Poster
Abstract Number: EP06.05-09
Session: EP06.05 Pathology and Biomarkers - Pathology
Abstract Link: https://cattendee.abstractsonline.com/meeting/10925/presentation/1348
A Quantitative Continuous Scoring (QCS) algorithm is being
developed as an automated methodology to identify patients who are
most likely to respond to treatment. This e-poster showcased the
application of this method based on information collected in the
Phase II SAVANNAH study. The global Phase III study SAFFRON will
serve as an additional independent validation cohort.
About Savolitinib (ORPATHYS(R) in China)
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 in China under the brand name
ORPATHYS(R) for the treatment of patients with non-small cell lung
cancer 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(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.
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 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, includ-ing its expectations regarding the thera-peutic
potential of savolitinib, the further clinical develop-ment 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; the sufficiency of
funding; 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, 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
Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
FTI Consulting 545 055 (Mobile)
HUTCHMED@fticonsulting.com
Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang , Panmure
Gordon +44 (20) 7886 2500
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