HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2025
HUTCHMED (NASDAQ/AIM:HCM) has announced multiple data presentations at the upcoming ESMO Congress 2025 in Berlin, Germany. The highlight will be the presentation of results from the FRUSICA-2 registration study examining fruquintinib and sintilimab combination as second-line treatment for renal cell carcinoma in a Mini Oral session.
Additional presentations include analyses of the FRUSICA-1 study in endometrial cancer and the SAVANNAH and SACHI studies in non-small cell lung cancer. The congress will feature both company-sponsored and investigator-initiated studies across multiple cancer types, including colorectal, gastric, lung, and pancreatic cancers, showcasing HUTCHMED's expanding oncology portfolio.
- Multiple clinical studies being presented at a major oncology conference demonstrating broad pipeline progress
- FRUSICA-2 registration study results selected for Mini Oral presentation, indicating potential significance
- Diverse portfolio of cancer treatments across multiple indications showing development progress
- None.
Insights
HUTCHMED will present promising cancer drug data at ESMO 2025, including potentially registration-enabling results for renal cell carcinoma treatment.
HUTCHMED's upcoming ESMO Congress 2025 presentations represent significant progress in their oncology pipeline development strategy. The highlight is the FRUSICA-2 registration study results featuring fruquintinib plus sintilimab combination therapy for advanced renal cell carcinoma (RCC). This phase 3 study compares the combination against established therapies (axitinib or everolimus), positioning it as a potential new second-line treatment option.
The extensive presentation lineup demonstrates HUTCHMED's broad development approach for their key assets across multiple tumor types. For fruquintinib, the company is presenting data beyond its already-approved indication in colorectal cancer, exploring combinations with various immunotherapies (sintilimab, tislelizumab) in endometrial cancer and colorectal cancer. The company is also showcasing novel AI-based biomarker research to predict patient outcomes.
For savolitinib, three presentations focus on MET-driven non-small cell lung cancer (NSCLC) in combination with osimertinib, including ctDNA analysis from the phase 3 SACHI trial. These studies address a critical resistance mechanism in EGFR-mutated NSCLC.
Additionally, the investigator-initiated studies for both fruquintinib and surufatinib across various tumor types (gastric, pancreatic, sarcoma) indicate broader clinical interest in these compounds. These exploratory studies could potentially lead to additional company-sponsored trials if promising signals emerge.
The breadth of data being presented suggests HUTCHMED is effectively advancing its pipeline with both registration-directed trials and strategic combinations targeting key oncology indications, particularly focusing on difficult-to-treat cancers with significant unmet needs.
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 02, 2025 (GLOBE NEWSWIRE) -- 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 European Society for Medical Oncology (“ESMO”) Congress 2025, taking place on October 17-21, 2025 in Berlin, Germany.
Results from the FRUSICA-2 registration study of the fruquintinib and sintilimab combination as a second-line treatment for locally advanced or metastatic renal cell carcinoma will be presented in a Mini Oral session. Additionally, further analyses of the fruquintinib FRUSICA-1 study in endometrial cancer and the savolitinib SACHI and SAVANNAH studies in non-small cell lung cancer will be presented during the poster sessions.
Details of the presentations are as follows:
| Abstract title | Presenter / Lead author | Presentation details |
SPONSORED STUDIES | ||
| Fruquintinib (FRUQ) plus sintilimab (SIN) versus axitinib (AXI) or everolimus (EVE) monotherapy as 2L treatment in pts with locally advanced or metastatic renal cell carcinoma (RCC): results from phase 3 part of a randomized, open-label, active-controlled phase 2/3 study (FRUSICA-2) | Zhenhua Liu (Chengdu, China) | 2592MO Mini Oral Session 1: GU tumours, renal & urothelial Friday, Oct 17, 2025 Karlsruhe Auditorium - Hall 5.2 16:00 - 17:30 CEST |
| A Fruquintinib Expanded Access Program (EAP) to Provide Treatment for Patients With Metastatic Colorectal Cancer (mCRC) | Stefan Kasper-Virchow (Essen, Germany) | 794P Poster Session: Colorectal cancer |
| Fruquintinib plus tislelizumab in microsatellite stable metastatic colorectal cancer: Results from a phase 1b/2 study | N. Arvind Dasari (Houston, USA) | 799P Poster Session: Colorectal cancer |
| A novel artificial intelligence (AI) imaging biomarker of tumor vascularity and heterogeneity radiomics to predict survival benefit of fruquintinib vs placebo in metastatic colorectal cancer (mCRC) | Sara Lonardi (Padua, Italy) | 804P Poster Session: Colorectal cancer |
| Safety and tolerability of fruquintinib: Pooled analysis of three placebo-controlled studies in patients with metastatic colorectal cancer | Cathy Eng (Nashville, USA) | 811P Poster Session: Colorectal cancer |
| Association between Metabolic Syndrome (MetS) and clinical outcomes of Fruquintinib plus Sintilimab in Previously Treated Advanced Endometrial Cancer (EMC) Patients with pMMR Status: results from FRUSICA-1 study | Danbo Wang (Shenyang, China) | 1230eP Poster Session: Gynaecological Cancer |
| ctDNA analysis in phase 3 SACHI trial: savolitinib (savo) plus osimertinib (osi) versus chemotherapy (chemo) in MET-amplified (METamp) advanced NSCLC after disease progression (PD) on EGFR tyrosine kinase inhibitor (TKI) | Yongfeng Yu (Shanghai, China) | 1954P Poster Session: NSCLC, metastatic |
| SAVANNAH: Safety and tolerability of osimertinib (osi) + savolitinib (savo) in EGFRm advanced NSCLC with MET overexpression and/or amplification (OverExp/Amp) following disease progression on osi | Quincy Siu-chung Chu (Edmonton, Canada) | 1955P Poster Session: NSCLC, metastatic |
| MET testing and treatment (tx) sequencing after progression on first line (1L) osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and acquired MET overexpression and/or amplification (OverExp/Amp): interim analysis of a global real world (rw) study | Julia Rotow (Boston, USA) | 1956P Poster Session: NSCLC, metastatic |
| INVESTIGATOR-INITIATED STUDIES | ||
| Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated surgical and survival results from the single-arm, phase 2 clinical trial | Fei Ma (Zhengzhou, China) | 2159P Poster Session: Oesophagogastric 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) | 898eP E-poster Session: Colorectal cancer |
| The efficacy and safety of surufatinib combined with chemotherapy in the first-line treatment of advanced periampullary carcinoma: a single arm, prospective, exploratory clinical study | Qianqian Wang (Nanjing, China) | 929P Poster Session: Developmental therapeutics |
| Surufatinib-Based Late-Line Therapy Outcomes in Recurrent Metastatic NSCLC: Monotherapy and Vinorelbine Combination Regimens | Yanfang Zheng (Guangzhou, China) | 1884P Poster Session: NSCLC, metastatic |
| Surufatinib combined with Toripalimab, Pemetrexed, and Platinum in Advanced Non-Squamous Non-Small Cell Lung Cancer (nsg-NSCLC): Final Phase II Results from a Single-Center Trial | Wenfeng Fang/ Li Zhang (Guangzhou, China) | 1887P Poster Session: NSCLC, metastatic |
| Efficacy/safety and preliminary scRNA-seq results of surufatinib plus gemcitabine and nab-paclitaxel as neoadjuvant therapy in resectable and borderline resectable pancreatic cancer | Song Gao/ Jihui Hao (Tianjin, China) | 2236P Poster Session: Pancreatic cancer |
| Efficacy and Safety of Surufatinib in Patients with Advanced Soft Tissue Sarcoma After Failure of Anthracycline Chemotherapy and Prior Effective Antiangiogenic Therapy: A Single-Arm, Prospective, Exploratory Phase II Study | Xiaowei Zhang/ Zhiguo Luo (Shanghai, China) | 2716P Poster Session: Sarcoma |
About Fruquintinib
Fruquintinib is a selective oral inhibitor of all three vascular endothelial growth factor receptors (“VEGFR”) -1, -2 and -3. Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. Takeda holds the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside mainland China, Hong Kong and Macau, marketing it under the brand name FRUZAQLA®.
About Savolitinib
Savolitinib is an oral, potent and highly selective MET tyrosine kinase inhibitor 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. Savolitinib is being jointly developed by AstraZeneca and HUTCHMED, and commercialized by AstraZeneca under the brand name ORPATHYS®.
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFRs and fibroblast growth factor receptor (FGFR), which both inhibit angiogenesis, and colony stimulating factor-1 receptor (CSF-1R), which regulates tumor-associated macrophages, promoting the body’s immune response against tumor cells. Surufatinib is marketed in China by HUTCHMED under the brand name SULANDA®. HUTCHMED currently retains all rights to surufatinib worldwide.
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, surufatinib and savolitinib, the further clinical development for fruquintinib, surufatinib and savolitinib, its expectations as to whether any studies on fruquintinib, surufatinib and 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 fruquintinib, surufatinib and 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 fruquintinib, surufatinib and 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 sintilimab and toripalimab 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 / Alex Shaw | +44 7771 913 902 (Mobile) / +44 7779 545 055 (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 |
| Freddie Barnfield / Jeffrey Wong / Duncan Monteith | +44 20 7260 1000 |
FAQ
What are the key studies HUTCHMED (HCM) is presenting at ESMO 2025?
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