RCS - Hutchmed China Ltd - HUTCHMED - Data to be Presented at AACR 2025
24/04/2025 07:02
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RNS Number : 8888F Hutchmed (China) Limited 24 April 2025
Press Release
HUTCHMED Highlights Data to be Presented at AACR Annual Meeting 2025
Hong Kong, Shanghai & Florham Park, NJ - Thursday, April 24, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from
several studies of compounds discovered by HUTCHMED including savolitinib,
fruquintinib and surufatinib, which will be presented at the upcoming American
Association of Cancer Research (AACR) Annual Meeting 2025, taking place on
April 25-30, 2025 in Chicago, Illinois.
Details of the presentations are as follows:
Abstract title Presenter / Lead author Presentation details
SPONSORED STUDIES
Targeting KEAP1/NRF2 signaling sensitizes KRAS-driven NSCLC to KRAS inhibitors Xianwen Yang, HUTCHMED, Shanghai, China 4450 (https://www.abstractsonline.com/pp8/#!/20273/presentation/2334)
Poster Session (PO.ET03.04)
Tuesday, April 29, 2025
SAVANNAH: Clearance of plasma EGFRm in patients with EGFRm MET-overexpressed Jonathan W. Riess, University of California, UC Davis Comprehensive Cancer LB416 (https://www.abstractsonline.com/pp8/#!/20273/presentation/10188)
(OverExp) and/or -amplified (Amp) NSCLC post-osimertinib (osi) treated with Center, CA, US
savolitinib (savo) + osi Late-Breaking Poster Session
(LBPO.CL04)
Wednesday, April 30, 2025
A phase I open-label positron-emission tomography study to determine brain Kowser Miah, AstraZeneca, Waltham, MA, US 4353 (https://www.abstractsonline.com/pp8/#!/20273/presentation/1100)
exposure of (11)C savolitinib in healthy volunteers
Poster Session (PO.ET07.01)
Tuesday, April 29, 2025
INVESTIGATOR-INITIATED STUDIES
A multi-cohort study of treatment regimens for metastatic colorectal cancer Wangxia Lv, Cancer Hospital of the University of Chinese Academy of Sciences/ CT085 (https://www.abstractsonline.com/pp8/#!/20273/presentation/10548)
(mCRC): Subgroup analysis of sequential therapy between fruquintinib and Zhejiang Cancer Hospital, Hangzhou, China
regorafenib Poster Session (PO.CT02.03)
Monday, April 28, 2025
Phase Ib/II study of fruquintinib (F) combined with capecitabine (C) as Lin Yang/ Kai Ou, Chinese Academy of Medical Sciences and Peking Union Medical CT222 (https://www.abstractsonline.com/pp8/#!/20273/presentation/10539)
maintenance therapy (MT) for RAS/BRAF wild-type metastatic colorectal cancer College, Beijing, China
(mCRC) after first-line treatment with cetuximab combined with chemotherapy Poster Session (PO.CT02.02)
Tuesday, April 29, 2025
Tyrosine kinase inhibitor (TKI) plus PD-1 blockade in TKI-responsive MSS/pMMR Jingdong Zhang/ Qian Dong, Liaoning Cancer Hospital & Institute, Cancer 6002 (https://www.abstractsonline.com/pp8/#!/20273/presentation/7742)
metastatic colorectal adenocarcinoma (mCRC): Results of a multicenter, phase Hospital of Dalian University of Technology, Shenyang, China
II trial (TRAP) Poster Session (PO.CL08.03)
Tuesday, April 29, 2025
Efficacy and mechanism of radiotherapy combined with fruquintinib and Xianglin Yuan, Tongji Hospital, Tongji Medical College, Huazhong University of 1828 (https://www.abstractsonline.com/pp8/#!/20273/presentation/6962)
tislelizumab in mCRC Science and Technology, Wuhan, China (https://www.abstractsonline.com/pp8/#!/20272/presentation/8071)
Poster Session (PO.ET08.02)
Monday, April 28, 2025
Prediction of surufatinib treatment outcome in advanced grade 3 neuroendocrine Jing Hao, Qilu Hospital of Shandong University, Jinan, China CT084 (https://www.abstractsonline.com/pp8/#!/20273/presentation/10547)
tumors (NET G3) patients
Poster Session (PO.CT02.03)
Monday, April 28, 2025
Surufatinib and sintilimab in combination with capecitabine for previously Yanhong Deng/ Xiaoyu Xie, The Sixth Affiliated Hospital of Sun Yat-sen CT033 (https://www.abstractsonline.com/pp8/#!/20273/presentation/10490)
treated metastatic small bowel adenocarcinoma or appendiceal carcinoma: A University, Guangzhou, China
single-arm, single-center, phase Ib/II trial Poster Session (PO.CT01.03)
Monday, April 28, 2025
GPR34-driven damage-response macrophages underlie therapeutic resistance to Song Gao, Tianjin Medical University Cancer Institute and Hospital, 6818 (https://www.abstractsonline.com/pp8/#!/20273/presentation/1075)
surufatinib Tianjin, China (https://www.abstractsonline.com/pp8/#!/20272/presentation/8068)
Poster Session (PO.ET07.02)
Wednesday, April 30, 2025
Efficacy and mechanism of surufatinib combination with PD-1 monoclonal Guanghai Dai/ Ru Jia, The Fifth Medical Center, Chinese PLA General Hospital, 6824 (https://www.abstractsonline.com/pp8/#!/20273/presentation/1088)
antibody and chemotherapy for the treatment of pancreatic cancer with liver Beijing, China
metastasis in animal models Poster Session (PO.ET07.02)
Wednesday, April 30, 2025
Efficacy and mechanistic insights of Shengyang Qushi Decoction in managing Huangying Tan, China-Japan Friendship Hospital, Beijing, China 1043 (https://www.abstractsonline.com/pp8/#!/20273/presentation/8494)
surufatinib-associated diarrhea
Poster Session (PO.PR02.03)
Sunday, April 27, 2025
About Lung Cancer
Lung cancer is the leading cause of cancer death, accounting for about
one-fifth of all cancer deaths. 1 (#_edn1) More than a third of the world's
lung cancer patients are in China. Lung cancer is broadly split into non-small
cell lung cancer ("NSCLC") and small cell lung cancer, with NSCLC accounting
for about 80% of cases. 2 (#_edn2) Approximately 10-15% of NSCLC patients in
the US and Europe and 30-40% of patients in Asia have an epidermal growth
factor receptor ("EGFR") mutation ("EGFRm"). 3 (#_edn3) (, 4 (#_edn4) , 5
(#_edn5) , 6 (#_edn6) ) Approximately 2-3% of NSCLC patients have tumors with
MET exon 14 skipping alterations, a targetable mutation in the MET gene. 7
(#_edn7)
About Savolitinib and MET Aberrations in Lung Cancer
Savolitinib is an oral, potent, and highly selective MET tyrosine kinase
inhibitor ("TKI") being jointly developed by AstraZeneca and HUTCHMED and
commercialized by AstraZeneca. MET is a tyrosine kinase receptor that has an
essential role in normal cell development. 8 (#_edn8) 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.(8, 9 (#_edn9) ) 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 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 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 Savolitinib in combination with TAGRISSO(®) (osimertinib)
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 savolitinib in combination with TAGRISSO(®) has been studied
extensively in these patients in the TATTON (NCT02143466
(https://clinicaltrials.gov/study/NCT02143466) ) and SAVANNAH (NCT03778229
(https://clinicaltrials.gov/study/NCT03778229#participation-criteria) )
studies. The encouraging results led to the initiation of several 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) ).
This combination represents a promising chemo-free oral treatment strategy to
address mechanisms of resistance in this advanced setting. Positive data from
the SACHI randomized Phase III trial has led to the filing of a second New
Drug Application ("NDA") in China
(https://www.hutch-med.com/orpathys-tagrisso-nda-acceptance-in-china-with-priority-review-status-for-lung-cancer-after-egfri/)
. Strong data from the SAVANNAH single-arm Phase II study was recently
presented at the European Lung Cancer Congress
(https://www.hutch-med.com/elcc25/) (ELCC) in March 2025 demonstrated high,
clinically meaningful and durable objective response rate (ORR), with
consistent safety results. The SAFFRON randomized Phase III trial is
progressing. Following AstraZeneca's consultation with the US Food and Drug
Administration ("FDA"), we look forward to completing the SAFFRON trial as
soon as possible to support potential US and other global registration
filings.
SACHI: The SACHI China Phase III trial met the primary endpoint of progression
free survival (PFS) during its interim analysis towards the end of 2024 and a
NDA was accepted and granted Breakthrough Therapy Designation and Priority
Review status in China in December 2024. SACHI evaluated the combination of
savolitinib and TAGRISSO(®) for the treatment of patients with EGFRm,
MET-amplified locally advanced or metastatic NSCLC after progression on EGFR
TKI compared to platinum-based doublet chemotherapy. Results will be presented
at an upcoming scientific conference.
SAFFRON: In 2023, savolitinib and TAGRISSO(®) received Fast Track Designation
from the US FDA in this setting. The global SAFFRON Phase III trial is
currently ongoing to assess the savolitinib plus TAGRISSO(®) combination
versus platinum-based doublet chemotherapy in patients with EGFRm,
MET-overexpressed and/or amplified, locally advanced or metastatic NSCLC
following progression on treatment with TAGRISSO(®). Patients are being
prospectively selected using the high MET level cut-off identified in
SAVANNAH.
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 fruquintinib, savolitinib
and surufatinib, the further clinical development for fruquintinib,
savolitinib and surufatinib, its expectations as to whether any studies on
fruquintinib, savolitinib and surufatinib 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 fruquintinib, savolitinib and
surufatinib, 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 fruquintinib, savolitinib and surufatinib
for a targeted indication, and the sufficiency of funding. In addition, as
certain studies rely on the use of osimertinib, capecitabine, sintilimab or
tislelizumab, 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
1 (#_ednref1) World Health Organization. International Agency for
Research on Cancer. All cancers fact sheet. Available at:
https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/39-all-cancers-fact-sheet.pdf)
. Accessed November 2022.
2 (#_ednref2) American Cancer Society. What is Lung Cancer? Available at:
https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html
(https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html) .
Accessed November 2022.
3 (#_ednref3) Knight SB, et al. Progress and prospects of early detection in
lung cancer. Open Biol. 2017;7(9): 170070. DOI: 10.1098/RSOB.170070
(https://doi.org/10.1098/rsob.170070) .
4 (#_ednref4) 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. DOI: 10.1200/JCO.2010.31.8923
(https://doi.org/10.1200/jco.2010.31.8923) .
5 (#_ednref5) 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). DOI: 10.18632/oncotarget.12587
(https://doi.org/10.18632/oncotarget.12587) .
6 (#_ednref6) 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. PMID: 24294366
(https://pubmed.ncbi.nlm.nih.gov/24294366/) .
7 (#_ednref7) Vuong HG, et al. Clinicopathological implications of MET exon
14 mutations in non-small cell lung cancer - A systematic review and
meta-analysis. Lung Cancer. 2018; 123: 76-82. DOI:
10.1016/j.lungcan.2018.07.006 (https://doi.org/10.1016/j.lungcan.2018.07.006)
.
8 (#_ednref8) Uchikawa E, et al. Structural basis of the activation of c-MET
receptor. Nat Commun. 2021;12(4074). DOI: 10.1038/s41467-021-24367-3
(https://doi.org/10.1038/s41467-021-24367-3) .
9 (#_ednref9) Wang Q, et al. MET inhibitors for targeted therapy of EGFR
TKI-resistant lung cancer. Journal of Hematology & Oncology. 2019;63. DOI:
10.1186/s13045-019-0759-9 (https://doi.org/10.1186/s13045-019-0759-9) .
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