RCS - Hutchmed China Ltd - Enrollment Complete in SAFFRON Global Phase III

HUTCHMED (China)Announcement

05/11/2025 07:00

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RNS Number : 1871G  Hutchmed (China) Limited  05 November 2025

Press Release

 

HUTCHMED Announces Enrollment Completed of SAFFRON Global Phase III Trial of
ORPATHYS(®) and TAGRISSO(®) Combination for Certain Lung Cancer Patients
with MET Overexpression and/or Amplification After Progression on
TAGRISSO(®)

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, November 5, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces the completion of patient enrollment
of SAFFRON, a global Phase III study of ORPATHYS(®) (savolitinib) and
TAGRISSO(®) (osimertinib) for the treatment of patients with epidermal growth
factor receptor ("EGFR")-mutated, MET-overexpressed and/or amplified, locally
advanced or metastatic non-small cell lung cancer ("NSCLC") following
progression on treatment with TAGRISSO(®). The last patient was randomized on
October 31, 2025.

 

This combination represents a promising, chemotherapy-free, all-oral treatment
option following progression on an EGFR tyrosine kinase inhibitor ("TKI"), and
was granted approval in China in June 2025 based on the results of the SACHI
randomized Phase III trial. ORPATHYS(®) is an oral, potent and highly
selective MET TKI being jointly developed by AstraZeneca and HUTCHMED and
commercialized by AstraZeneca. TAGRISSO(®) is a third-generation,
irreversible EGFR TKI.

 

SAFFRON is a global Phase III, open-label, randomized, multicenter study to
investigate the efficacy and safety of ORPATHYS(®) administered orally in
combination with TAGRISSO(®) versus platinum-based doublet chemotherapy in
participants with EGFR-mutated, MET-overexpressed and/or amplified, locally
advanced or metastatic NSCLC who have progressed on first- or second-line
treatment with TAGRISSO(®) as the most recent therapy. The primary endpoint
of the study is progression free survival (PFS) as assessed by blinded
independent central review (BICR) according to RECIST 1.1 criteria. Other
endpoints include overall survival (OS), objective response rate ("ORR"),
duration of response (DoR), disease control rate (DCR), time to response
(TTR), and safety. This study randomized 338 patients, screened from over 230
sites across 29 countries. Additional details may be found at
clinicaltrials.gov, using identifier NCT05261399
(https://www.clinicaltrials.gov/study/NCT05261399) .

 

Topline results from the SAFFRON study are estimated to be reported in the
first half of 2026, followed by submission of results for presentation at an
appropriate medical congress.  If favorable, the results could support global
regulatory filings for the ORPATHYS(®) and TAGRISSO(®) combination.

 

About NSCLC and MET aberrations

 

Lung cancer is the leading cause of cancer death, accounting for about
one-fifth of all cancer deaths. 1  Lung cancer is broadly split into NSCLC and
small cell lung cancer, with 80-85% classified as NSCLC. 2  The majority of
NSCLC patients (approximately 75%) are diagnosed with advanced disease, and
approximately 10-15% of NSCLC patients in the US and Europe and up to 40-50%
of patients in Asia have EGFR-mutated ("EGFRm") NSCLC. 3 (, 4 , 5 , 6 , 7 )

 

MET is a tyrosine kinase receptor that has an essential role in normal cell
development. MET overexpression and/or amplification can lead to tumor growth
and the metastatic progression of cancer cells, and is one of the mechanisms
of de novo or acquired resistance to EGFR TKI for metastatic EGFRm
NSCLC. 8 (, 9 )

 

About ORPATHYS(®)

 

ORPATHYS(®) (savolitinib) is an oral, potent and highly selective MET TKI
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.

 

ORPATHYS(®) is approved in China and is marketed by AstraZeneca for the
treatment of adult patients with locally advanced or metastatic NSCLC with MET
exon 14 skipping alterations, representing the first selective MET inhibitor
approved in China. ORPATHYS(®) is also approved in China for the treatment of
patients with locally advanced or metastatic EGFRm-positive non-squamous NSCLC
with MET amplification after disease progression on EGFR tyrosine kinase
inhibitor therapy, in combination with TAGRISSO(®).

 

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 TAGRISSO(®)

 

TAGRISSO(®) (osimertinib) is a third-generation, irreversible EGFR-TKI with
proven clinical activity in NSCLC, including against central nervous system
(CNS) metastases. TAGRISSO(®) (40mg and 80mg once-daily oral tablets) has
been used to treat more than one million patients across its indications
worldwide and AstraZeneca continues to explore TAGRISSO(®) as a treatment for
patients across multiple stages of EGFRm NSCLC.

 

There is an extensive body of evidence supporting the use of TAGRISSO(®) in
EGFRm NSCLC, and it is the only targeted therapy shown to improve patient
outcomes across all stages of the disease.

 

In late-stage disease, TAGRISSO(®) demonstrated improved outcomes as
monotherapy in the FLAURA
(https://www.astrazeneca.com/media-centre/press-releases/2019/tagrisso-significantly-improves-overall-survival-in-the-phase-iii-flaura-trial-for-1st-line-egfr-mutated-non-small-cell-lung-cancer-09082019.html)
Phase III trial and in combination with chemotherapy in the FLAURA2
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemo-improved-pfs-in-lung-cancer.html)
Phase III trial. TAGRISSO(®) is also being investigated in this setting in
combination with ORPATHYS(®) (savolitinib) in the SAFFRON
(https://clinicaltrials.gov/study/NCT05261399) Phase III trial and in
combination with DATROWAY(®) (datopotamab deruxtecan or Dato-DXd) in the
TROPION-Lung14 (https://clinicaltrials.gov/study/NCT06350097) and
TROPION-Lung15 (https://clinicaltrials.gov/study/NCT06417814) Phase III
trials.

 

TAGRISSO(®) also showed improved outcomes in early-stage disease in the
NeoADAURA and ADAURA
(https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-demonstrated-strong-overall-survival-benefit-in-the-adaura-phase-iii-trial.html)
Phase III trials and in locally advanced stages in the LAURA
(https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-improved-pfs-in-stage-iii-lung-cancer.html)
Phase III trial. As part of AstraZeneca's ongoing commitment to treating
patients as early as possible in lung cancer, TAGRISSO(®) is also being
investigated in the early-stage adjuvant resectable setting in the ADAURA2
Phase III trial.

 

About ORPATHYS(®) and TAGRISSO(®) Combination Development in EGFR-mutated NSCLC

 

This combination represents a promising chemotherapy-free oral treatment
strategy to address mechanisms of resistance in this setting. Among patients
who experience disease progression following treatment with a third-generation
EGFR TKI, approximately 15-50% present with MET aberration, depending on the
sample type, detection method and assay cut-off used. TAGRISSO(®) is a
third-generation, irreversible EGFR-TKI with proven clinical activity in
NSCLC, including against central nervous system metastases. Treatment with
ORPATHYS(®) in combination with TAGRISSO(®) has been studied extensively in
these patients in the TATTON study (NCT02143466
(https://clinicaltrials.gov/study/NCT02143466) ) and the SAVANNAH single-arm
Phase II study (NCT03778229
(https://clinicaltrials.gov/study/NCT03778229#participation-criteria) ).
Strong data from SAVANNAH presented at the 2025 European Lung Cancer Congress
(https://www.hutch-med.com/elcc25/) (ELCC) demonstrated high, clinically
meaningful and durable ORR, with consistent safety results. The encouraging
results led to the initiation of several randomized Phase III trials in this
setting including the SACHI trial in China (NCT05015608
(https://clinicaltrials.gov/study/NCT05015608) ) and the global SAFFRON trial
(NCT05261399 (https://www.clinicaltrials.gov/study/NCT05261399) ), as well as
the SANOVO trial in China (NCT05009836
(https://clinicaltrials.gov/study/NCT05009836) ).

 

SACHI: This Phase III trial in China evaluated the combination of
ORPATHYS(®) and TAGRISSO(®) compared to platinum-based doublet chemotherapy
for the treatment of patients with EGFRm, MET-amplified locally advanced or
metastatic NSCLC following progression on treatment with an EGFR TKI. Results
were presented at the 2025 ASCO Annual Meeting
(https://www.hutch-med.com/sachi_asco25/) . The treatment combination received
approval in China
(https://www.hutch-med.com/china-approval-for-orpathys-plus-tagrisso-for-lung-cancer-with-met-amplification-after-1l-egfr-inhibitor/)
in June 2025.

 

SAFFRON: This ongoing global Phase III trial is to evaluate the combination
of ORPATHYS(®) and TAGRISSO(®) compared to platinum-based doublet
chemotherapy in patients with EGFRm, MET-overexpressed and/or amplified,
locally advanced or metastatic NSCLC following progression on treatment with
TAGRISSO(®). This received Fast Track Designation from the US Food and Drug
Administration (FDA) and enrollment was completed in October 2025. We look
forward to completing this trial to support potential US and other global
registration filings.

 

SANOVO: This ongoing Phase III trial in China is to evaluate the combination
of ORPATHYS(®) and TAGRISSO(®) compared to TAGRISSO(®) monotherapy in
previously untreated patients with locally advanced or metastatic NSCLC with
EGFRm and MET overexpression. Enrollment was completed in August 2025.

 

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 its expectations regarding the
therapeutic potential of ORPATHYS(®), the further clinical development for
ORPATHYS(®), its expectations as to whether any studies on ORPATHYS(®) 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
ORPATHYS(®), including as a combination therapy, to meet the primary or
secondary endpoint of a study, to obtain regulatory approval in other
jurisdictions and to gain commercial acceptance after obtaining regulatory
approval; the potential market of ORPATHYS(®) for a targeted indication; and
HUTCHMED and/or its partner's ability to fund, implement and complete its
further clinical development and commercialization plans for ORPATHYS(®), and
the timing of these events. In addition, as certain studies rely on the use of
other drug products such as TAGRISSO(®) as combination therapeutics with
ORPATHYS(®), such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval of these
therapeutics. 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 / Tim Stamper                              +44 7771 913 902 (Mobile) / +44 7421 898 348 (Mobile)
 Brunswick - Zhou Yi                                   +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                       (mailto:HUTCHMED@brunswickgroup.com)

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

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

 Deutsche Numis                                        Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith    +44 20 7260 1000

 

 1   World Health Organization. International Agency for Research on Cancer.
All cancers fact sheet. Available at:
https://gco.iarc.fr/today/-data/factsheets/cancers/39-All-cancers-fact-sheet.pdf
(https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf)
. Accessed November 2022.

 2   American Cancer Society. What is Lung Cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html
(https://www.cancer.org/cancer/lung-cancer/about/what-is.html) . Accessed
November 2022.

 3  Knight SB, et al. Progress and prospects of early detection in lung
cancer. Open Biol. 2017;7(9): 170070.

 4  Keedy VL, et al. American Society of Clinical Oncology Provisional
Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for
Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR
Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27.

 5  Zhang Y, et al. The prevalence of EGFR mutation in patients with non-small
cell lung cancer: a systematic review and meta-analysis. Oncotarget.
2016;7(48).

 6  Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and
Histological Samples in 11. Non-Small Cell Lung Cancer: a Polish, Single
Institution Study and Systematic Review of European Incidence. Int J Clin
Exp Pathol. 2013:6;2800-12.

 7  Gou LY, et al. Prevalence of driver mutations in non-small-cell lung
cancers in the People's Republic of China. Lung Cancer: Targets and Therapy.
2014; 5; 1-9.

 8  Uchikawa E, et al. Structural basis of the activation of c-MET receptor.
Nat Commun. 2021;12(4074).

 9  Wang Q, et al. MET inhibitors for targeted therapy of EGFR TKI-resistant
lung cancer. Journal of Hematology & Oncology. 2019;63.

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