RCS - Hutchmed China Ltd - HUTCHMED Highlights Data to be Presented at ASCO

HUTCHMED (China)Announcement

23/05/2025 07:00

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RNS Number : 8488J  Hutchmed (China) Limited  23 May 2025

Press Release

 

HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, May 23, 2025: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new data from several studies of compounds
discovered by HUTCHMED including savolitinib, ranosidenib, fruquintinib and
surufatinib, will be presented at the American Society of Clinical Oncology
("ASCO") Annual Meeting taking place on May 30 - June 3, 2025 in Chicago, USA.

 

Results from the SACHI China Phase III study of savolitinib in combination
with osimertinib in 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 EGFR inhibitor
therapy will be presented at a late breaking oral presentation. SACHI had met
the pre-defined primary endpoint of progression-free survival (PFS) in a
planned interim analysis. SACHI data supports the New Drug Application (NDA)
for this oral-only treatment, which has been accepted and granted priority
review
(https://www.hutch-med.com/orpathys-tagrisso-nda-acceptance-in-china-with-priority-review-status-for-lung-cancer-after-egfri/)
in China.

 

Further data with additional analysis stratified by brain metastasis status
from a high MET overexpression and/or amplification treatment subset of the
SAVANNAH Phase II study of the savolitinib and osimertinib combination in
NSCLC patients harboring EGFR mutation and MET amplification or
overexpression after progressing on osimertinib were reported. The
savolitinib and osimertinib combination demonstrated better efficacy outcomes
compared to savolitinib plus placebo. The combination showed promising central
nervous system ("CNS") activity, with reduced CNS progression and fewer new
CNS lesions.

 

Results will be presented from the dose-escalation stage of the Phase I study
of ranosidenib (HMPL-306), a novel, small-molecule, highly selective oral
dual-inhibitor of both Isocitrate dehydrogenase ("IDH") 1 and IDH2 enzymes,
being studied in patients with locally advanced or metastatic solid tumors
with IDH mutations. Results show that the compound was well tolerated, showing
target inhibition and durable responses in patients. Efficacy signals were
observed especially in the efficacy evaluated group of lower-grade glioma
patients (N=14), with an objective response rate ("ORR") of 7.1% and a disease
control rate ("DCR") of 100%.

 

Results will also be presented from the sub-group analyses of the FRUSICA-1
open-label, single-arm, pivotal Phase II study to evaluate the efficacy and
safety of fruquintinib plus sintilimab in previously treated advanced
endometrial cancer (EMC) patients with pMMR (proficient mismatch repair)
status. Efficacy findings for patients with serous carcinoma (N=27) were
clinically meaningful and characterized by responses similar to those observed
in full trial population (N=98), with an Independent Review Committee
("IRC")-assessed ORR of 37.0% and a DCR of 88.9%. The analysis of whether the
response was affected by prior neoadjuvant/adjuvant chemotherapy ("NACT/ACT")
showed durable and clinically meaningful responses regardless of whether the
patient had received NACT/ACT. Results were comparable for patients with and
without prior NACT/ACT, with an IRC-assessed ORR of 34.0% versus 31.4% and DCR
of 85.1% versus 82.4%, respectively.

 

Results from two subgroup analyses of a Phase IV study of fruquintinib
involving 2,798 colorectal cancer patients in China will be presented. In the
subgroup analysis evaluating the safety of fruquintinib as monotherapy and in
combination therapy, fruquintinib demonstrated a manageable safety profile in
both groups. Treatment-emergent adverse events (TEAE) of Grade 3 or above
occurred in 23.94% in the fruquintinib monotherapy group and 26.06% in the
combination therapy group with other anti-cancer treatments. The most common
treatment related adverse events (TRAE) of any grade in both groups were
palmar-plantar erythrodysesthesia (PPES) and hypertension. The combination
therapy group exhibited a longer treatment duration, potentially indicating
improved patient outcomes. In the subgroup analysis by age, the safety of
fruquintinib was assessed in younger (age <50) and late-elderly (age ≥75)
patients. The safety profile was comparable across both age groups, with
younger patients receiving more intensive treatment. Combination therapy with
fruquintinib also showed a longer duration than monotherapy in both age
subgroups, which may suggest improved survival potential.

 

Details of the presentations, including links to available abstracts, are as
follows:

 

 Abstract title                                                                   Presenter / Lead author                                                         Presentation details
 SPONSORED STUDIES
 Savolitinib (Savo) combined with osimertinib (osi) versus chemotherapy (chemo)   Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University School of       LBA8505 (https://meetings.asco.org/abstracts-presentations/246124)
 in EGFR-mutant (EGFRm) and MET-amplification (METamp) advanced NSCLC after       Medicine, Shanghai, China

 disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI): Results from                                                                                   Oral Abstract Session: Lung Cancer - Non-Small Cell Metastatic
 a randomized phase 3 SACHI study

                                                                                                                                                                  Sunday, June 1, 2025

                                                                                                                                                                  9:48 AM CDT
 Efficacy and CNS results from a randomized subset of the phase 2 SAVANNAH        Benjamin Philip Levy, Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins  8513 (https://meetings.asco.org/abstracts-presentations/247755)
 study comparing savolitinib (savo) + osimertinib (osi) combination with savo +   University School of Medicine, Baltimore, MD

 placebo (PBO)                                                                                                                                                    Rapid Oral Session: Lung Cancer - Non-Small Cell Metastatic

                                                                                                                                                                  Monday, June 2, 2025

                                                                                                                                                                  8:06 AM CDT
 Phase I study of HMPL-306, an inhibitor of mutant IDH1/IDH2 (mIDH1/2), in        Jordi Rodon Ahnert, The University of Texas MD Anderson Cancer Center,          2013 (https://meetings.asco.org/abstracts-presentations/247911)
 western patients (pts) with advanced mIDH solid tumor, including glioma          Houston, TX

                                                                                                                                                                  Rapid Oral Session: Central Nervous System Tumors

                                                                                                                                                                  Saturday, May 31, 2025

3:06 PM CDT
 Analysis of serous carcinoma subgroup in FRUSICA-1: Fruquintinib plus            Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China            5596 (https://meetings.asco.org/abstracts-presentations/243908)
 sintilimab in treated advanced endometrial cancer (EMC) patients (pts) with

 pMMR status                                                                                                                                                      Poster Session: Gynecologic Cancer
 The Impact of Prior Neoadjuvant/Adjuvant Chemotherapy (NACT/ACT) on              Jing Wang, Hunan Cancer Hospital, Changsha, China                               5611 (https://meetings.asco.org/abstracts-presentations/243932)
 Fruquintinib Plus Sintilimab Outcomes in Advanced Endometrial Cancer (EMC)

 Patients with pMMR Status: A Subgroup Analysis of FRUSICA-1                                                                                                      Poster Session: Gynecologic Cancer
 Safety of fruquintinib in young and late-elderly Chinese patients with           Yi Wang, Ningbo No.2 Hospital, Ningbo, China                                    e15512 (https://meetings.asco.org/abstracts-presentations/244867)
 colorectal cancer in real-world clinical practice: Age subgroup analysis of a

 fruquintinib Phase IV study                                                                                                                                      Publication Only: Gastrointestinal Cancer - Colorectal and Anal
 Safety of fruquintinib monotherapy and combination therapy in Chinese Patients   Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China           e15515 (https://meetings.asco.org/abstracts-presentations/244872)
 with colorectal cancer in real-world clinical practice: A subgroup analysis

 from Phase IV study                                                                                                                                              Publication Only: Gastrointestinal Cancer - Colorectal and Anal
 The appropriate therapeutic sequence with angiogenesis inhibitor and             Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China              e16011 (https://meetings.asco.org/abstracts-presentations/250728)
 chemotherapy in patients with advanced gastric or gastroesophageal junction

 adenocarcinoma: Exploratory analysis from the Phase III FRUTIGA study                                                                                            Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 Subgroup analysis of efficacy and safety of fruquintinib plus paclitaxel         Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, Shanghai, China    e16012 (https://meetings.asco.org/abstracts-presentations/250729)
 versus paclitaxel in gastroesophageal junction adenocarcinoma patients from

 FRUTIGA: A randomized Phase III clinical trial in second-line treatment of                                                                                       Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
 gastric/gastroesophageal junction                                                                                                                                Hepatobiliary

 INVESTIGATOR-INITIATED STUDIES
 Fruquintinib in combination with camrelizumab and paclitaxel liposome and        Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University,        4042 (https://meetings.asco.org/abstracts-presentations/249677)
 nedaplatin as first-line treatment for advanced esophageal squamous cell         Nanjing, China

 carcinoma (ESCC): a single-arm, Phase II study                                                                                                                   Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 Updated results of fruquintinib combined with PD-1 inhibitors and chemotherapy   Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China         4046 (https://meetings.asco.org/abstracts-presentations/249748)
 in the first-line treatment of HER2-negative advanced gastric or

 gastroesophageal junction adenocarcinoma (FDZL-FIX): a single-arm, open-label                                                                                    Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
 Phase II study                                                                                                                                                   Hepatobiliary
 Open-label, single-arm, single-center Phase Ib/II clinical study of              Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan       TPS4203 (https://meetings.asco.org/abstracts-presentations/252322)
 fruquintinib combined with trastuzumab and XELOX in the first-line treatment     Cancer Hospital, Zhengzhou, China

 of advanced HER2-positive metastatic gastric or gastroesophageal junction                                                                                        Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
 adenocarcinoma                                                                                                                                                   Hepatobiliary
 A multi-cohort real-world study of treatment for metastatic colorectal cancer    Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of         e15530 (https://meetings.asco.org/abstracts-presentations/244892)
 (mCRC): Overall efficacy analysis and subgroup analysis of previous              Sciences (Zhejiang Cancer Hospital), Hangzhou, China

 bevacizumab use or not                                                                                                                                           Publication Only: Gastrointestinal Cancer - Colorectal and Anal

 Real-world Observational Study of Fruquintinib in Combination with Irinotecan    Ling Xu, the First Hospital of China Medical University, Shenyang, China        e15539 (https://meetings.asco.org/abstracts-presentations/244912)
 and Capecitabine as Second-line Treatment in Patients with Advanced Colorectal

 Cancer                                                                                                                                                           Publication Only: Gastrointestinal Cancer - Colorectal and Anal
 Preliminary results of fruquintinib in combination with FOLFIRI as second-line   Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China      e15541 (https://meetings.asco.org/abstracts-presentations/244915)
 treatment for RAS-mutant metastatic colorectal cancer: a prospective

 single-center Phase II study                                                                                                                                     Publication Only: Gastrointestinal Cancer - Colorectal and Anal
 Evaluating the efficacy of fruquintinib versus regorafenib and                   Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital,     e15550 (https://meetings.asco.org/abstracts-presentations/244931)
 trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A      China Pharmaceutical University, Nanjing, China

 match-adjusted indirect comparison                                                                                                                               Publication Only: Gastrointestinal Cancer - Colorectal and Anal
 Fruquintinib plus sintilimab and SOX as conversion therapy for initially         Fei Ma, Henan Cancer Hospital, Zhengzhou, China                                 e16016 (https://meetings.asco.org/abstracts-presentations/250745)
 unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC):

 Updated response and surgical results from a single-arm, Phase II clinical                                                                                       Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
 trial                                                                                                                                                            Hepatobiliary
 A Phase II study to evaluate the efficacy and safety of fruquintinib combined    Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People's         e23506 (https://meetings.asco.org/abstracts-presentations/251400)
 with envafolimab in patients with advanced or unresectable locally advanced      Hospital, Shanghai, China

 osteosarcoma and soft tissue sarcoma                                                                                                                             Publication Only: Sarcoma
 Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second line    Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of           4028 (https://meetings.asco.org/abstracts-presentations/249523)
 (2L) treatment for advanced gastric cancer (aGC): Final results from a Phase     Medicine, Shanghai, China

 II trial                                                                                                                                                         Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in        Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China             4157 (https://meetings.asco.org/abstracts-presentations/249526)
 first line (1L) advanced pancreatic cancer (PC): a single-arm, Phase Ib/II

 trial                                                                                                                                                            Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1     Ru Jia/ Guanghai Dai, the Fifth Medical Center of the PLA General Hospital,     4161 (https://meetings.asco.org/abstracts-presentations/249559)
 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A     Beijing, China

 Phase Ib/II Randomized Study                                                                                                                                     Poster Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 A prospective, single-arm, Phase II trial exploring the use of pamiparib         Bairong Xia, The First Affiliated Hospital of University of Science and         5589 (https://meetings.asco.org/abstracts-presentations/244145)
 combined with surufatinib as neoadiuvant therapy for advanced, unresectable      Technology of China, Hefei, China

 ovarian cancer (PASSION)                                                                                                                                         Poster Session: Gynecologic Cancer
 The efficacy and safety of Surufatinib monotherapy as a third-line treatment     Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China               e16209 (https://meetings.asco.org/abstracts-presentations/250838)
 for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center

 Phase II study                                                                                                                                                   Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 Surufatinib combined with gemcitabine and cisplatin and immune checkpoint        Jingtao Zhang/ Xuetao Shi, Cancer Hospital of Shandong First Medical            e16222 (https://meetings.asco.org/abstracts-presentations/250870)
 inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic     University, Jinan, China

 cholangiocarcinoma                                                                                                                                               Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 Updated results from a multicenter, single-arm Phase ll study of surufatinib     Ming Lu/ Lin Shen, Peking University Cancer Hospital, Beijing, China            e16342 (https://meetings.asco.org/abstracts-presentations/250771)
 plus sintilimab and lBl310 in patients with high-grade advanced neuroendocrine

 neoplasm (HG-NEN)                                                                                                                                                Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary
 A prospective, single-arm, Phase II study of surufatinib in combination with     Song Gao/ Jihui Hao, Tianjin Medical University Cancer Institute and Hospital,  e16442 (https://meetings.asco.org/abstracts-presentations/250746)
 gemcitabine and nab-paclitaxel for the neoadjuvant treatment of resectable and   Tianjin, China

 borderline resectable pancreatic cancer                                                                                                                          Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and
                                                                                                                                                                  Hepatobiliary

 

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, ranosidenib,
fruquintinib and surufatinib, the further clinical development for
savolitinib, ranosidenib, fruquintinib and surufatinib, its expectations as to
whether any studies on savolitinib, ranosidenib, fruquintinib 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 savolitinib, ranosidenib, fruquintinib 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 savolitinib, ranosidenib, fruquintinib and surufatinib for a
targeted indication, and the sufficiency of funding. In addition, as certain
studies rely on the use of other drug products 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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