HUTCHMED Highlights Data to be Presented at ASCO

Summary by AI BETAClose X

HUTCHMED announced that new and updated clinical data for its compounds savolitinib, fruquintinib, and surufatinib will be presented at the 2026 ASCO Annual Meeting. Notably, the pivotal Phase II registration study of savolitinib in MET-amplified gastric cancer met its primary endpoint with an objective response rate of 32.3%, supporting its New Drug Application submission in China. Additional presentations will cover fruquintinib's performance in colorectal and renal cell carcinoma studies, as well as investigator-initiated studies across various tumor indications, alongside surufatinib data in ovarian cancer and thymic epithelial tumors.

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Hutchmed (China) Limited
22 May 2026
 

Press Release

 

HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting

Hong Kong, Shanghai & Florham Park, NJ - Friday, May 22, 2026: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology ("ASCO") Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA.

 

Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate ("ORR") per RECIST 1.1, as assessed by the Independent Review Committee ("IRC"). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025.

 

Additionally, further analyses of the fruquintinib's FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented.

 

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

 

Abstract title

Presenter / Lead Author

Presentation details

SPONSORED STUDIES

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas

Zhi Peng, Beijing, China

4011
Rapid Oral Abstract Session: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary
Monday, June 1, 2026 1:15 PM CDT

Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2

Elena Elez, Barcelona, Spain

3555
Poster Session: Gastrointestinal Cancer - Colorectal and Anal 

Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study

Kaiwei Yang, Beijing, China

4531
Poster Session:
Genitourinary Cancer
-
Kidney and Bladder  

Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden

Yuanyuan Qu, Shanghai, China

4533
Poster Session:
Genitourinary Cancer
-
Kidney and Bladder  

Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1

Xiaotian Han, Shanghai, China

e17612
Publication Only: Gynecologic Cancer

 



INVESTIGATOR-INITIATED STUDIES

Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial

Jianmin Xu, Shanghai, China

LBA3563
Poster Session: Gastrointestinal Cancer - Colorectal and Anal

CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer

Yue Liu, Hangzhou, China

TPS3680
Poster Session
: Gastrointestinal Cancer - Colorectal and Anal

Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial

Joseph Tintelnot, Hamburg, Germany

TPS3684
Poster Session
: Gastrointestinal Cancer - Colorectal and Anal

A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety

Chang Wang, Changchun, China

2631
Poster Session
: Developmental Therapeutics - Immunotherapy

Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study

Yun Xu, Shanghai, China

3528
Poster Session
: Gastrointestinal Cancer - Colorectal and Anal

A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC)

Wenhua Li, Shanghai, China

3534
Poster Session
: Gastrointestinal Cancer - Colorectal and Anal

A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases

Mengzhou Guo, Shanghai, China

3552
Poster Session
: Gastrointestinal Cancer - Colorectal and Anal

Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study

Xiaodong Zhu, Shanghai, China

4063
Poster Session
: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial)

Hao Wen, Shanghai, China

5579
Poster Session
: Gynecologic Cancer

Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study

Wangjun Liao, Guangzhou, China

e15539
Publication Only: Gastrointestinal Cancer - Colorectal and Anal

Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study

Yifu He/ Jiayu Niu, Hefei, China

e15560
Publication Only: Gastrointestinal Cancer - Colorectal and Anal

Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer

Qian Li, Nanning, China

e15571
Publication Only: Gastrointestinal Cancer - Colorectal and Anal

Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial

Wei Li, Suzhou, China

e15583
Publication Only: Gastrointestinal Cancer - Colorectal and Anal

Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States

Vasu Bansal, Kansas City, US

e15713
Publication Only: Gastrointestinal Cancer - Colorectal and Anal

Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION)

Beibei Chen, Zhengzhou, China

e16033
Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study

Yanhong Gu, Nanjing, China

e16070
Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma

Xuetao Shi/ Jingtao Zhong, Jinan, China

4136
Poster Session
: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial

Wenquan Wang, Shanghai, China

4198
Poster Session
: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial

Huijuan Yang, Shanghai, China

5586
Poster Session
: Gynecologic Cancer

Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study

Bei Xu, Shanghai, China

8119
Poster Session
: Lung Cancer - Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study

Fuxiang Zhou, Wuhan, China

e16172
Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study

Shasha Fan, Changsha, China

e16222
Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and Hepatobiliary

Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study

Xiang Han, Qingdao, China

e20079
Publication Only: Lung Cancer -
Non-Small Cell Local-Regional/
Small Cell/Other Thoracic Cancers

 

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 or follow us on LinkedIn.

 

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 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



Media Enquiries


FTI Consulting -

+44 20 3727 1030 / HUTCHMED@fticonsulting.com

   Ben Atwell / Tim Stamper

   +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile)

Brunswick - Zhou Yi

+852 9783 6894 (Mobile) / 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

Duncan Monteith / Ramin Naji

+44 20 7545 8000

 

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