RCS - Hutchmed China Ltd - Phase IIIb Savolitinib Results at WCLC 2023

HUTCHMED (China)Announcement

12/09/2023 09:30

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RNS Number : 0502M  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 (https://www.hutch-med.com/) ")
(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
                   (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 (https://classic.clinicaltrials.gov/ct2/show/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
(https://classic.clinicaltrials.gov/ct2/show/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
                   (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
(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 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 (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.

 

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 (http://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, 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) /

FTI Consulting                                                   +44 7779 545 055 (Mobile)
                                                                   HUTCHMED@fticonsulting.com (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi,                                                          +852 9783 6894 (Mobile)

Brunswick                                                        HUTCHMED@brunswickgroup.com (mailto:HUTCHMED@brunswickgroup.com)

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

 

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