HUTCHMED to Present Promising Cancer Therapy Data at ASCO 2025
HUTCHMED (China) Limited has announced its participation in the American Society of Clinical Oncology (ASCO) Annual Meeting, scheduled for May 30 – June 3, 2025, in Chicago. The company will unveil new data on its cancer therapies, including savolitinib, ranosidenib, fruquintinib, and surufatinib.
Key Highlights from HUTCHMED’s Upcoming Presentations
Among the notable findings, results from the Phase III SACHI study will show that savolitinib, when combined with osimertinib, improves progression-free survival in patients with advanced non-small cell lung cancer (NSCLC) with MET amplification. Furthermore, presentations will cover various studies that highlight the efficacy and safety of HUTCHMED’s drug candidates. Ranoseidenib shows favorable tolerance in patients with solid tumors, while fruquintinib has promising outcomes in treating advanced endometrial and colorectal cancers. Safety analyses indicate that fruquintinib maintains a manageable side effect profile across different patient age groups, with continuous treatment suggesting better patient outcomes.
Strengths of HUTCHMED’s Research and Development
- The upcoming ASCO presentations reflect HUTCHMED’s commitment to advancing oncology research and development.
- The SACHI study’s interim analysis shows promising efficacy for the savolitinib and osimertinib combination, supporting further regulatory applications.
- Data from ranosidenib highlight early efficacy and tolerability for patients with IDH mutations, indicating potential for impactful treatments.
- Robust data from fruquintinib studies suggest significant clinical outcomes, enhancing HUTCHMED’s standing in oncology.
Challenges and Considerations
- Concerns about ranosidenib’s effectiveness were raised, as the objective response rate (ORR) was only 7.1% in lower-grade glioma patients, indicating limited impact.
- Safety concerns emerged regarding fruquintinib, which showed 23.94% treatment-emergent adverse events (TEAEs) at Grade 3 or above in monotherapy and 26.06% in combination therapy.
- The reliance on positive outcomes from multiple studies introduces uncertainty surrounding future regulatory approvals and market acceptance of HUTCHMED’s therapies.
Frequently Asked Questions
What is the significance of HUTCHMED’s upcoming data at ASCO 2025?
The presented data will focus on the efficacy of critical compounds like savolitinib and ranosidenib in cancer treatment.
When and where will HUTCHMED present its findings?
HUTCHMED will showcase its research at the ASCO Annual Meeting in Chicago from May 30 to June 3, 2025.
What were the promising findings from the SACHI Phase III study?
The SACHI study indicated improved progression-free survival for savolitinib combined with osimertinib in NSCLC patients.
How effective was ranosidenib in the Phase I study?
Ranosidenib was well-tolerated and demonstrated a 7.1% objective response rate in lower-grade glioma patients, alongside a 100% disease control rate.
What does the safety profile of fruquintinib look like in colorectal cancer treatment?
Fruquintinib presents a manageable safety profile, exhibiting tolerability in both monotherapy and combination therapy for colorectal cancer patients.
$HCM Hedge Fund Activity
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Some significant changes include:
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Full Release
HONG KONG and SHANGHAI and FLORHAM PARK, N.J., May 23, 2025 (GLOBE NEWSWIRE) — HUTCHMED (China) Limited (“
HUTCHMED
”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new data from several studies of compounds developed by HUTCHMED—including savolitinib, ranosidenib, fruquintinib, and surufatinib—will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting from May 30 – June 3, 2025, in Chicago, USA.
Results from the SACHI China Phase III study evaluating savolitinib alongside osimertinib in patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive NSCLC, specifically with MET amplification after prior disease progression on EGFR inhibitors, will be disclosed in a late-breaking oral presentation. The SACHI study met its primary endpoint of progression-free survival (PFS) in an interim analysis, supporting the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China.
Further data with additional analyses from the SAVANNAH Phase II study on savolitinib and osimertinib in NSCLC patients harboring EGFR mutation with MET amplification or overexpression after progression on osimertinib will demonstrate potentially improved efficacy outcomes compared to savolitinib plus placebo. This combination therapy shows promising central nervous system (CNS) activity, evidenced by reduced CNS progression and fewer new CNS lesions.
Results will additionally be shared from the dose-escalation phase of the Phase I study of ranosidenib (HMPL-306), a novel oral dual-inhibitor of the IDH 1 and IDH 2 enzymes, being investigated in patients with locally advanced or metastatic solid tumors with IDH mutations. Findings indicate the compound is well-tolerated, demonstrating target inhibition and durable responses, especially among lower-grade glioma patients (N=14), with an objective response rate (ORR) of 7.1% and a notable disease control rate.
# Fruquintinib Efficacy and Safety Insights from Recent Studies
The recent analysis of phase II and phase IV studies shed light on fruquintinib, particularly regarding its safety and efficacy in treating advanced endometrial and colorectal cancers.
## Key Findings from the FRUSICA-1 Study
The FRUSICA-1 trial assessed fruquintinib in combination with sintilimab for advanced endometrial cancer (EMC) patients who previously underwent treatment. Among patients with proficient mismatch repair (pMMR) status, the overall response rate (ORR) was 37.0% with a disease control rate (DCR) of 88.9%. This subgroup comprised 27 patients with serous carcinoma, demonstrating responses akin to the broader study population of 98 patients. Notably, patients’ responses remained robust irrespective of prior neoadjuvant/adjuvant chemotherapy (NACT/ACT) treatment. Specifically, the IRC-assessed ORR showed 34.0% in those with NACT/ACT and 31.4% in those without, with corresponding DCR values of 85.1% and 82.4%.
## Insights from the Phase IV Study on Colorectal Cancer
A phase IV investigation involving 2,798 colorectal cancer patients in China offered further insights into fruquintinib’s safety profile. When administered as monotherapy, fruquintinib resulted in treatment-emergent adverse events (TEAE) of grade 3 or higher in 23.94% of patients. In the combination therapy cohort, this figure slightly increased to 26.06%, indicating a manageable safety profile across both groups. The most frequent adverse events included palmar-plantar erythrodysesthesia (PPES) and hypertension. Notably, patients receiving combination therapy demonstrated extended treatment durations, suggesting potentially more favorable outcomes.
Analyzing safety across age groups, the study compared younger patients (under 50) with those aged 75 and older. Results indicated that fruquintinib’s safety profile remained consistent across both demographics, with younger patients undergoing more intensive treatments. In both age categories, combination therapy outperformed monotherapy in duration, hinting at better survival prospects.
## Presentation Details
Findings will be available through various presentations at upcoming events, including:
Abstract title | Presenter / Lead author | Presentation details |
SPONSORED STUDIES | ||
Savolitinib combined with osimertinib versus chemotherapy in EGFR-mutant NSCLC | Shun Lu, Shanghai Chest Hospital | LBA8505
Oral Abstract Session: Lung Cancer – Non-Small Cell Metastatic Sunday, June 1, 2025, 9:48 AM CDT |
Efficacy and CNS results from the phase 2 SAVANNAH study | Benjamin Philip Levy, Johns Hopkins University | 8513
Rapid Oral Session: Lung Cancer – Non-Small Cell Metastatic Monday, June 2, 2025, 8:06 AM CDT |
Phase I study of HMPL-306 in advanced mIDH solid tumors | Jordi Rodon Ahnert, The University of Texas MD Anderson | 2013
Rapid Oral Session: Central Nervous System Tumors Saturday, May 31, 2025, 3:06 PM CDT |
Analysis of serous carcinoma subgroup in FRUSICA-1 | Xiaohua Wu, Fudan University | 5596
Poster Session: Gynecologic Cancer |
The Impact of Prior NACT/ACT on Fruquintinib Outcomes | Jing Wang, Hunan Cancer Hospital | 5611
Poster Session: Gynecologic Cancer |
Safety of fruquintinib in young and late-elderly patients |
# Recent Studies on Fruquintinib for Cancer Treatment in China
Yi Wang, Ningbo No.2 Hospital, Ningbo, China |
e15512 Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
|
Safety of Fruquintinib Monotherapy and Combination Therapy in Chinese Patients with Colorectal Cancer: A Subgroup Analysis from a Phase IV Study |
Zhiqiang Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China |
e15515 Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
The Appropriate Therapeutic Sequence with Angiogenesis Inhibitor and Chemotherapy in Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: Exploratory Analysis from the Phase III FRUTIGA Study |
Jin Li, Shanghai East Hospital, Tongji University, Shanghai, China |
e16011 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Subgroup Analysis of Efficacy and Safety of Fruquintinib Plus Paclitaxel versus Paclitaxel Alone in Gastroesophageal Junction Adenocarcinoma Patients: A Randomized Phase III Clinical Trial |
Tianshu Liu, Zhongshan Hospital, Fudan University, Shanghai, China |
e16012 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
INVESTIGATOR-INITIATED STUDIES |
||
Fruquintinib in Combination with Camrelizumab and Paclitaxel Liposome and Nedaplatin as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma (ESCC): A Single-Arm, Phase II Study |
Yanhong Gu, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China |
4042 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Updated Results of Fruquintinib Combined with PD-1 Inhibitors and Chemotherapy in First-Line Treatment of HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FDZL-FIX): A Single-Arm, Open-Label Phase II Study |
Chenchen Wang, Fudan University Shanghai Cancer Center, Shanghai, China |
4046 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Open-Label, Single-Arm, Single-Center Phase Ib/II Clinical Study of Fruquintinib Combined with Trastuzumab and XELOX in First-Line Treatment of Advanced HER2-Positive Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma |
Huifang Lv, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China |
TPS4203 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
A Multi-Cohort Real-World Study of Treatment for Metastatic Colorectal Cancer (mCRC): Overall Efficacy Analysis and Subgroup Analysis of Previous Bevacizumab Use |
Wangxia Lv, The Cancer Hospital of the University of Chinese Academy of Sciences (Zhejiang Cancer Hospital), Hangzhou, China |
e15530 Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
Real-World Observational Study of Fruquintinib in Combination with Irinotecan and Capecitabine as Second-Line Treatment in Patients with Advanced Colorectal Cancer |
Ling Xu, The First Hospital of China Medical University, Shenyang, China |
e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
Recent Studies on Fruquintinib and Surufatinib in Cancer Treatments
Preliminary results of fruquintinib in combination with FOLFIRI as second-line treatment for RAS-mutant metastatic colorectal cancer: a prospective single-center Phase II study | Ru Jia, Fifth Medical Center, Chinese PLA General Hospital, Beijing, China |
e15541
Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
Evaluating the efficacy of fruquintinib versus regorafenib and trifluridine/tipiracil in treating advanced metastatic colorectal cancer: A match-adjusted indirect comparison | Shukui Qin, Gastrointestinal Cancer Center of Nanjing Tianyinshan Hospital, China Pharmaceutical University, Nanjing, China |
e15550
Publication Only: Gastrointestinal Cancer – Colorectal and Anal |
Fruquintinib plus sintilimab and SOX as conversion therapy for initially unresectable gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): Updated response and surgical results from a single-arm, Phase II clinical trial | Fei Ma, Henan Cancer Hospital, Zhengzhou, China |
e16016
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
A Phase II study to evaluate the efficacy and safety of fruquintinib combined with envafolimab in patients with advanced or unresectable locally advanced osteosarcoma and soft tissue sarcoma | Chenliang Zhou, Shanghai Jiao Tong University Affiliated Sixth People’s Hospital, Shanghai, China |
e23506
Publication Only: Sarcoma |
Efficacy and safety of surufatinib (Sur) plus paclitaxel (Pac) as second-line treatment for advanced gastric cancer (aGC): Final results from a Phase II trial | Xiuying Xiao, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China |
4028
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Efficacy and safety of surufatinib (S) plus KN046 (K) and chemotherapy in first-line treatment of advanced pancreatic cancer (PC): a single-arm, Phase Ib/II trial | Wenquan Wang, Zhongshan Hospital, Fudan University, Shanghai, China |
4157
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
First-Line Treatment with Surufatinib, Camrelizumab, Nab-paclitaxel, and S-1 in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC): A Phase Ib/II Randomized Study | Ru Jia/Guanghai Dai, the Fifth Medical Center of the PLA General Hospital, Beijing, China |
4161
Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
A prospective, single-arm, Phase II trial exploring the use of pamiparib combined with surufatinib as neoadjuvant therapy for advanced, unresectable ovarian cancer (PASSION) | Bairong Xia, The First Affiliated Hospital of University of Science and Technology of China, Hefei, China |
5589
Poster Session: Gynecologic Cancer |
The efficacy and safety of Surufatinib monotherapy as a third-line treatment for advanced hepatocellular carcinoma: A single-arm, open-label, multi-center Phase II study | Fuxiang Zhou, Zhongnan Hospital of Wuhan University, Wuhan, China |
e16209
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma | Jingtao Zhang/Xuetao Shi, Cancer Hospital of Shandong First Medical University, Jinan, China |
e16222
Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
# New Phase II Study Results Highlight Surufatinib in Advanced Neuroendocrine Neoplasms
Updated Results of Surufatinib with Sintilimab and LBl310 in High-Grade Neuroendocrine Noplasm |
Ming Lu / Lin Shen, Peking University Cancer Hospital, Beijing, China |
e16342 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
Prospective Phase II Study of Surufatinib Combined with Gemcitabine and Nab-Paclitaxel for Pancreatic Cancer |
Song Gao / Jihui Hao, Tianjin Medical University Cancer Institute and Hospital, Tianjin, China |
e16442 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary |
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is a biopharmaceutical company focused on developing targeted therapies and immunotherapies for cancer and immunological diseases. The company has successfully brought multiple drug candidates from discovery to market. The first three medicines are already marketed in China, with one approved globally including in the US, Europe, and Japan. For more information, please visit:
www.hutch-med.com
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 statements reflect HUTCHMED’s expectations about future events, such as the therapeutic potential of savolitinib, ranosidenib, fruquintinib, and surufatinib, along with their clinical development and potential market acceptance. Certain risks and uncertainties may affect these expectations, such as enrollment rates in studies, unexpected adverse events, and regulatory approvals. Investors are cautioned not to place undue reliance on these forward-looking statements. Further discussion of these risks is available in HUTCHMED’s filings with relevant securities authorities.
Medical Information
This release includes information about products that may not be available in all countries or may be available under different trademarks and indications. Nothing should be interpreted as a solicitation or advertisement for prescription drugs currently under development.
CONTACTS
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