HUTCHMED Highlights Presentation of Results from the Phase IIIb Trial of Savolitinib at the 2023 World Conference of Lung Cancer
September 12 2023 - 4:30AM
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® 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® 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® 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® 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, including 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; 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 |
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Media Enquiries |
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FTI Consulting |
HUTCHMED@fticonsulting.com |
Zhou Yi, |
+852 9783 6894 (Mobile) |
Brunswick |
HUTCHMED@brunswickgroup.com |
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Nominated Advisor |
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Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
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