RCS - Hutchmed China Ltd - HUTCHMED Highlights SACHI Phase III Data at ASCO

HUTCHMED (China)Announcement

02/06/2025 07:00

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RNS Number : 8594K  Hutchmed (China) Limited  02 June 2025

Press Release

 

HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting

 

- The all-oral chemotherapy-free combination of savolitinib plus osimertinib
demonstrated significant PFS benefit with a favorable safety profile in the
SACHI Phase III China study -

 

- Webcast to be held at 8:30 am HKT on Tuesday, June 3 to discuss the data
presented -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, June 2, 2025: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) announces primary results from the interim analysis of the SACHI
Phase III study. These results were presented in a late-breaking oral
presentation on Sunday, June 1, 2025, during the American Society of Clinical
Oncology ("ASCO") Annual Meeting in Chicago, USA.

 

SACHI is a Phase III  study of the savolitinib and osimertinib combination
for the treatment of patients with locally advanced or metastatic epidermal
growth factor receptor ("EGFR") mutation-positive non-small cell lung cancer
("NSCLC") with MET amplification after disease progression on first-line EGFR
inhibitor therapy (clinicaltrials.gov identifier NCT05015608
(https://clinicaltrials.gov/ct2/show/NCT05015608) ).

 

 Title:            Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant and
                   MET-amplification advanced NSCLC after disease progression on EGFR tyrosine
                   kinase inhibitor: Results from a randomized Phase III SACHI study
 Lead Author:      Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of
                   Medicine, Shanghai, China
 Session:          Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic
 Abstract Number:  LBA8505 (https://meetings.asco.org/abstracts-presentations/246124)
 Date & Time:      Sunday, June 1, 2025, 8:00 AM Central Daylight Time
 Location:         Arie Crown Theater

 

Prof. Shun Lu, Chief of the Shanghai Lung Cancer Center at Shanghai Chest
Hospital, School of Medicine, Shanghai Jiaotong University, and Principal
Investigator of the SACHI study, said, "The results from the SACHI Phase III
study represent a significant advancement in the treatment of EGFR
mutation-positive NSCLC with MET amplification. The savolitinib and
osimertinib combination demonstrates promising efficacy in patients who have
progressed on prior EGFR inhibitor therapy. These findings highlight the
potential of this novel, chemotherapy-free combination to enable a continued
oral regimen, offering a convenient and well-tolerated treatment option that
addresses critical unmet needs for patients with this challenging disease."

 

HUTCHMED will host a webcast to discuss the data presented at the ASCO Annual
Meeting at 8:30 -9:00 am HKT on Tuesday, June 3, 2025 (8:30 - 9:00 pm EDT
on June 2, 2025). The event will be held in English and can be accessed
via www.hutch-med.com/event (https://www.hutch-med.com/event/) . A replay
will also be available on the website shortly after the event.

 

As of the interim analysis data cut-off of August 30, 2024, a total of 211
patients were randomized to receive the savolitinib and osimertinib
combination or chemotherapy. In the intention to treat (ITT) population, the
median progression-free survival ("PFS") assessed by investigator was 8.2
months with savolitinib plus osimertinib, compared to 4.5 months with
chemotherapy (hazard ratio  "HR"  0.34; 95% confidence interval  "CI" 
0.23-0.49; p < 0.0001). The independent review committee ("IRC") assessed
median PFS was 7.2 months vs 4.2 months, respectively (HR 0.40; 95% CI
0.28-0.59; p < 0.0001).

 

The investigator-assessed objective response rate (ORR) was 58% in the
savolitinib plus osimertinib group compared to 34% for patients in the
chemotherapy group. The disease control rate (DCR) was 89% vs 67% and the
median duration of response (DoR) was 8.4 months vs 3.2 months, respectively.
Overall survival was not mature at the time of the interim analysis.

 

Efficacy outcomes in the third-generation EGFR tyrosine kinase inhibitor
("TKI")-treated patients were comparable with those in the intention-to-treat
and third-generation EGFR-TKI-naïve populations. In the third generation
EGFR-TKI-treated subgroup, the investigator-assessed and IRC-assessed median
PFS were highly consistent, both at 6.9 vs 3.0 months (HR 0.32; p <
0.0001).

 

The safety profile of the savolitinib and osimertinib combination was
tolerable and no new safety signals were observed. Treatment-emergent adverse
events of Grade 3 or above occurred in 57% of patients in the savolitinib plus
osimertinib group compared to 57% for patients in the chemotherapy group,
suggesting a favorable safety profile.

 

In January 2025, the Independent Data Monitoring Committee (IDMC) of SACHI has
considered that the study has met the pre-defined primary endpoint of PFS in a
planned interim analysis and as a result, enrollment into the study has
concluded. Supported by data from SACHI, a New Drug Application (NDA) for the
combination of savolitinib and osimertinib for the treatment of patients with
locally advanced or metastatic EGFR mutation-positive NSCLC with MET
amplification after disease progression on first-line EGFR inhibitor therapy
has been accepted and granted priority review by the China National Medical
Products Administration (NMPA).

 

About Savolitinib

Savolitinib is an oral, potent, and highly selective MET TKI that has
demonstrated clinical activity in advanced solid tumors. MET is a tyrosine
kinase receptor that has an essential role in normal cell
development. Savolitinib 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. MET overexpression and/or amplification can lead to tumor
growth and the metastatic progression of cancer cells, and is a known
mechanism of acquired resistance to EGFR TKIs. The prevalence of MET depends
on the sample type, detection method and assay cut-off used.

 

Savolitinib is approved in China and is marketed under the brand name
ORPATHYS(®) by our partner, AstraZeneca, for the treatment of adult patients
with locally advanced or metastatic NSCLC with MET exon 14 skipping
alteration, representing the first selective MET inhibitor approved in China.
It has been included (https://www.hutch-med.com/orpathys-nrdl-inclusion/) in
the National Reimbursement Drug List of China (NRDL) since March 2023.

 

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.

 

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. Since inception it has
focused on bringing drug candidates from in-house discovery to patients around
the world, with its first three medicines marketed in China, the first of
which is also approved around the world including in the US, Europe and Japan.
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 US Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, including but not limited to 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. 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 combination therapies,
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 markets of savolitinib for a
targeted indication, and the sufficiency of funding. In addition, as certain
studies rely on the use of other drug products such as osimertinib as
combination therapeutics, such risks and uncertainties include assumptions
regarding their safety, efficacy, supply and continued regulatory approval.
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 US 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.

Medical Information

This press release contains information about products that may not be
available in all countries, or may be available under different trademarks,
for different indications, in different dosages, or in different strengths.
Nothing contained herein should be considered a solicitation, promotion or
advertisement for any prescription drugs including the ones under development.

 

CONTACTS
 Investor Enquiries                                   +852 2121 8200 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                     +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                      (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                               +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                  +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                      (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                      Nominated Advisor and Joint Broker
 Atholl Tweedie / Freddy Crossley / Rupert Dearden    +44 20 7886 2500

 HSBC                                                 Joint Broker
 Simon Alexander / Alina Vaskina / Arnav Kapoor       +44 20 7991 8888

 Cavendish                                            Joint Broker
 Geoff Nash / Nigel Birks                             +44 20 7220 0500

 

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