HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting
HUTCHMED (China) announced it will present new and updated data from several studies at the 2024 ASCO Annual Meeting. Key highlights include the Phase II study of fruquintinib combined with sintilimab in endometrial cancer patients, showing an objective response rate (ORR) of 35.6%, disease control rate (DCR) of 88.5%, and median progression-free survival (PFS) of 9.5 months. The study supported a New Drug Application (NDA) in China. Additionally, updated data from the Phase III FRUTIGA study in gastric cancer, and data from the FRESCO and FRESCO-2 studies in colorectal cancer will be presented. Other presentations include studies on surufatinib and the ERK1/2 inhibitor HMPL-295.
The ASCO Annual Meeting will take place from May 31 to June 4, 2024, in Chicago, IL, and online.
- Phase II study of fruquintinib combined with sintilimab in EMC patients showed an ORR of 35.6%.
- DCR in the Phase II study was 88.5%.
- Median PFS in Phase II study was 9.5 months.
- Median OS in Phase II study was 21.3 months.
- Data supported NDA filing in China.
- Updated data from the FRUTIGA Phase III study in gastric cancer to be presented.
- Additional data from FRESCO and FRESCO-2 studies in colorectal cancer.
- Initial clinical data for ERK1/2 inhibitor HMPL-295 will be presented.
- The duration of response in the Phase II study was not reached.
- Potentially high expectations set by the data might not translate into commercial success.
- Median follow-up time of 15.7 months might be considered short for long-term efficacy evaluation.
HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., May 23, 2024 (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 upcoming American Society of Clinical Oncology (“ASCO”) Annual Meeting, taking place May 31 – June 4, 2024 in Chicago, IL and online.
Results will be presented from the registration Phase II study of fruquintinib combined with sintilimab in 98 second-line or above patients with endometrial cancer (“EMC”) with pMMR status by central laboratory analysis, which supported the New Drug Application (NDA) filed in China. The primary endpoint was objective response rate (“ORR”) per RECIST v1.1, assessed by an independent review committee. The combination showed meaningful efficacy improvements in advanced EMC patients with pMMR status, regardless of prior bevacizumab treatment, with a manageable safety profile. The median follow-up time was 15.7 months. The ORR in 87 efficacy evaluable patients was
Following the initial data of the FRUTIGA Phase III study of fruquintinib in second-line gastric cancer published during the February 2024 ASCO Plenary Series session, further updated efficacy data in key subgroups, and quality of life data will be presented at this year’s ASCO annual meeting. In addition, further data from the FRESCO and FRESCO-2 Phase III colorectal cancer studies, the study of surufatinib combinations in small cell lung cancer, and initial clinical data for the ERK1/2 inhibitor HMPL-295 will be presented.
Details of the presentations, including links to available abstracts, are as follows:
| Abstract title | Presenter / Lead author | Presentation details | |
SPONSORED STUDIES | |||
| Fruquintinib plus Sintilimab in Treated Advanced Endometrial Cancer (EMC) Patients (Pts) with pMMR Status: Results From a Multicenter, Single-Arm Phase 2 Study | Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai, China | #5619 Poster Session - Gynecologic Cancer | |
| Efficacy and safety of fruquintinib in patients with metastatic colorectal cancer according to prior treatment sequence in the refractory setting: Results from FRESCO and FRESCO-2 | Tanios S. Bekaii-Saab, Mayo Clinic, U.S. | #3579 Poster Session - Gastrointestinal Cancer — Colorectal and Anal | |
| Fruquintinib in Refractory Metastatic Colorectal Cancer | Cathy Eng, Vanderbilt-Ingram Cancer Center, U.S. | Link Education Session: New Drugs in Oncology: Incorporation Into Practice | |
| Updates on Abstract 438730: Fruquintinib Plus Paclitaxel Versus Paclitaxel as Second-Line Therapy for Patients with Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (FRUTIGA): A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Phase 3 Study | Feng Wang, Sun Yat-Sen University Cancer Center, Guangzhou, China | Link Education Session: ASCO Plenary Series: Rapid Abstract Updates | |
| Surufatinib plus PD-1/L1 inhibitors as maintenance therapy following first line (1L) platinum-based chemotherapy combined with PD-1/L1 inhibitors in patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) | Yi Hu, Chinese PLA General Hospital, Beijing, China | #e15109 Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology | |
| First-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with advanced solid tumors: dose-escalation results of monotherapy | Xianjun Yu, Fudan University Shanghai Cancer Center, Shanghai, China | #e15112 Publication Only: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology | |
INVESTIGATOR-INITIATED STUDIES | |||
| Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab in metastatic colorectal cancer: updated findings from a single-arm, prospective phase II trial (RIFLE) | Chen Yajie, Zhang Zhen, Fudan University Shanghai Cancer Center, Shanghai, China | #e15570 Publication Only: Gastrointestinal Cancer—Colorectal and Anal | |
| A propensity score matched comparison of fruquintinib (FRU) versus FRU combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic colorectal cancer: real-world data | Lina He, Shuiping Tu, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China | #e15564 Publication Only: Gastrointestinal Cancer—Colorectal and Anal | |
| Phase Ib/II trial of hepatic arterial infusion chemotherapy (HAIC) in combination with fruquintinib as third-line therapy for refractory unresectable colorectal cancer liver metastases | Zhu Xu, Peking University Cancer Hospital and Institute, Beijing, China | #3561 Poster Session - Gastrointestinal Cancer—Colorectal and Anal | |
| Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as third-line treatment in patients with metastatic colorectal adenocarcinoma: Results from a single arm, phase 2, multicenter study | Jianjun Peng, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China | #3536 Poster Session - Gastrointestinal Cancer — Colorectal and Anal | |
| A phase II study to evaluate the efficacy and safety of fruquintinib combined with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced colorectal cancer liver metastases: An updated analysis of survival | Lu Wang, Zhang Ti, Fudan University Shanghai Cancer Center, Shanghai, China | #3543 Poster Session - Gastrointestinal Cancer — Colorectal and Anal | |
| Fruquintinib combined with sintilimab and SOX as conversion therapy for unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial | Suxia Luo, Fei Ma, Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China | #e16021 Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary | |
| Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer (LARC): a multicenter, single-arm, open-label, phase II study | Tao Zhang, Zhenyu Lin, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | TPS3643 Poster Session: Gastrointestinal Cancer — Colorectal and Anal | |
| Fruquintinib plus capecitabine versus capecitabine as first-line maintenance treatment of metastatic colorectal cancer (mCRC): Update results from the randomized, controlled, phase Ib/II study | Junjie Peng, Wenhua Li, Fudan University Shanghai Cancer Center, Shanghai, China | #3567 Poster Session: Gastrointestinal Cancer — Colorectal and Anal | |
| Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy as second-line therapy in metastatic colorectal cancer: updated results of a multicenter, single-arm, phase 2 trial | Yongshun Chen, Wensi Zhao, Renmin Hospital of Wuhan University, Wuhan, China | #3571 Poster Session: Gastrointestinal Cancer — Colorectal and Anal | |
| Comparative analysis of first-line therapy with fruquintinib plus chemotherapy versus standard therapy in advanced metastatic colorectal cancer (mCRC): A prospective cohort study compared with propensity score matching (PSM) cohort | Fuxiang Zhou, Wenbo Wang, Zhongnan Hospital of Wuhan University, Wuhan, China | #3591 Poster Session: Gastrointestinal Cancer —Colorectal and Anal | |
| Efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after developing resistance to several TKIs: A multi-centered retrospective study | Lu Xie, Binghao Li, Peking University People’s Hospital, Beijing, China; The Second Affiliated Hospital Zhejiang University, Hangzhou, China | #11528 Poster Session: Sarcoma | |
| Disitamab vedotin combined with fruquintinib in patients with HER2-expressing or HER2 mutation/amplified metastatic colorectal cancer refractory to at least two standard regimens: A prospective, exploratory, single-arm study | Hui Xu, Zhongnan Hospital of Wuhan University. Wuhan, China | #e15003 Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology | |
| Surufatinib combined with TAS-102 in third- or later-line therapy of patients with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II Study | Dongsheng Zhang, Sun Yat-sen University Cancer Center, Guangzhou, China | #e16297 Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary | |
| Surufatinib monotherapy or combined with vinorelbine as a late-line therapy in patients with refractory advanced non-small cell lung cancer (NSCLC) | Yanfang Zheng, Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou, China | #e20543 Publication Only: Lung Cancer — Non-Small Cell Metastatic | |
| Updated efficacy and safety results from the phase Ib/II study of surufatinib combined with camrelizumab and chemotherapy in patients with advanced colorectal cancer | Liangjun Zhu, Sheng Li, Jiangsu Cancer Hospital, Nanjing, China | #e15547 Publication Only: Gastrointestinal Cancer — Colorectal and Anal | |
| Phase II study to evaluate surufatinib in patients with osteosarcoma and soft tissue sarcoma who have failed in standard chemotherapy: updated analysis | Xing Zhang, Sun Yat-sen University Cancer Center, Guangzhou, China | #11539 Poster Session: Sarcoma | |
| Efficacy and safety of Surufatinib combined with EP regimen and Serplulimab in first-line treatment of NEC | Tao Zhang, Zhenyu Lin, Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | #e15123 Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology | |
| Performance of surufatinib in treating advanced neuroendocrine neoplasms: Insights from a real-world study | Qing Zhai, Linhui Zhu, Fudan University Shanghai Cancer Center; Shanghai Medical College, Fudan University, Shanghai, China | #e15124 Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology | |
| Epidemiological investigation of neuroendocrine differentiation in carcinomas: Focus on pancreatic and cholangiocarcinoma cohorts | Susheng Shi, Yaru Wen, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China | #e16375 Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary | |
| Efficacy and safety of surufatinib, toripalimab, nab-paclitaxel in combination with radiotherapy or surgery in the first-line treatment of esophageal squamous cell cancer: A single-centered prospective clinical trial | Fang Liu, Xiang Huang, Chinese PLA General Hospital, Beijing, China | #e16047 Publication Only: Gastrointestinal Cancer — Gastroesophageal, Pancreatic, and Hepatobiliary | |
| Efficacy and safety of second-line treatment with surufatinib for anlotinib-resistant radioiodine-refractory differentiated thyroid cancer: An exploratory multicenter study | Libo Chen, Yang Wang, Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China | #e15127 Publication Only: Developmental Therapeutics — Molecularly Targeted Agents and Tumor Biology | |
About HUTCHMED
HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery, global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception, HUTCHMED has focused on bringing cancer 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 marketed in the U.S. 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 U.S. 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 HMPL-295, the further clinical development for fruquintinib, surufatinib and HMPL-295, its expectations as to whether any studies on fruquintinib, surufatinib and HMPL-295, 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 HMPL-295, 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 HMPL-295 for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of nab-paclitaxel, sintilimab, toripalimab, pemetrexed, platinum, etoposide or cisplatin 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 U.S. 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 | |
| Ben Atwell / Alex Shaw, FTI Consulting | +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com |
| Zhou Yi, Brunswick | +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com |
| Nominated Advisor | |
| Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon | +44 (20) 7886 2500 |
FAQ
What did HUTCHMED announce about the 2024 ASCO Annual Meeting?
What is the ORR for fruquintinib combined with sintilimab in the Phase II study?
What is the median PFS for fruquintinib combined with sintilimab in EMC patients?
When will the 2024 ASCO Annual Meeting take place?
What is the disease control rate (DCR) in the Phase II study of fruquintinib combined with sintilimab?
What is the median overall survival (OS) for fruquintinib combined with sintilimab in EMC patients?
What other studies will HUTCHMED present at the 2024 ASCO Annual Meeting?
