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RCS - Hutchmed China Ltd - HUTCHMED Presentations at 2024 ASCO Annual Meeting

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RNS Number : 7030P  Hutchmed (China) Limited  24 May 2024

Press Release

 

HUTCHMED Highlights Presentations at the 2024 ASCO Annual Meeting

 

 

Hong Kong, Shanghai & Florham Park, NJ - Friday, May 24, 2024: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (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 35.6%
including two complete responses. Disease control rate ("DCR") was 88.5%, and
duration of response was not reached, with 80.7% remaining in response after
nine months. Amongst the 98 patients, median progression-free survival (PFS)
was 9.5 months, and median overall survival (OS) was 21.3 months. Further
details are available in the abstract link below.

 

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)        Xiaohua Wu,                                                                     #5619 (https://meetings.asco.org/abstracts-presentations/234546)
 Patients (Pts) with pMMR Status: Results From a Multicenter, Single‑Arm

 Phase 2 Study                                                                    Fudan University Shanghai Cancer Center, Shanghai, China                        Poster Session - Gynecologic Cancer

 Efficacy and safety of fruquintinib in patients with metastatic colorectal       Tanios S. Bekaii-Saab,                                                          #3579 (https://meetings.asco.org/abstracts-presentations/234184)
 cancer according to prior treatment sequence in the refractory setting:

 Results from FRESCO and FRESCO-2                                                 Mayo Clinic, U.S.                                                               Poster Session - Gastrointestinal Cancer - Colorectal and Anal

 Fruquintinib in Refractory Metastatic Colorectal Cancer                          Cathy Eng,                                                                      Link (https://meetings.asco.org/abstracts-presentations/230961)

Vanderbilt-Ingram Cancer Center, U.S.

                                                                                                                                                                  Education Session: New Drugs in Oncology: Incorporation Into Practice

 Updates on Abstract 438730: Fruquintinib Plus Paclitaxel Versus Paclitaxel as    Feng Wang,                                                                      Link (https://meetings.asco.org/abstracts-presentations/230955)
 Second-Line Therapy for Patients with Advanced Gastric or Gastroesophageal

 Junction Adenocarcinoma (FRUTIGA): A Randomized, Multicenter, Double-Blind,      Sun Yat-Sen University Cancer Center, Guangzhou, China                          Education Session: ASCO Plenary Series: Rapid Abstract Updates
 Placebo-Controlled, Phase 3 Study

 Surufatinib plus PD-1/L1 inhibitors as maintenance therapy following first       Yi Hu,                                                                          #e15109 (https://meetings.asco.org/abstracts-presentations/235513)
 line (1L) platinum-based chemotherapy combined with PD-1/L1 inhibitors in

 patients (pts) with extensive-stage small cell lung cancer (ES-SCLC)             Chinese PLA General Hospital, Beijing, China                                    Publication Only: Developmental Therapeutics - Molecularly Targeted Agents and

                                                                                                                                                                Tumor Biology

 First-in-human study of HMPL-295, an ERK1/2 inhibitor, in patients with          Xianjun Yu,                                                                     #e15112 (https://meetings.asco.org/abstracts-presentations/235532)
 advanced solid tumors: dose-escalation results of monotherapy

                                                                                Fudan University Shanghai Cancer Center, Shanghai, China                        Publication Only: Developmental Therapeutics-Molecularly Targeted Agents and
                                                                                                                                                                  Tumor Biology

 INVESTIGATOR-INITIATED STUDIES
 Stereotactic ablative radiotherapy combined with fruquintinib and tislelizumab   Chen Yajie, Zhang Zhen,                                                         #e15570 (https://meetings.asco.org/abstracts-presentations/237557)
 in metastatic colorectal cancer: updated findings from a single-arm,

 prospective phase II trial (RIFLE)                                               Fudan University Shanghai Cancer Center, Shanghai, China                        Publication Only: Gastrointestinal Cancer-Colorectal and Anal

 A propensity score matched comparison of fruquintinib (FRU) versus FRU           Lina He, Shuiping Tu,                                                           #e15564 (https://meetings.asco.org/abstracts-presentations/237539)
 combined with PD-1 inhibitors for microsatellite stability (MSS) metastatic

 colorectal cancer: real-world data                                               Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai,     Publication Only: Gastrointestinal Cancer-Colorectal and Anal

                                                                                China

 Phase Ib/II trial of hepatic arterial infusion chemotherapy (HAIC) in            Zhu Xu,                                                                         #3561 (https://meetings.asco.org/abstracts-presentations/237071)
 combination with fruquintinib as third-line therapy for refractory

 unresectable colorectal cancer liver metastases                                  Peking University Cancer Hospital and Institute, Beijing, China                 Poster Session - Gastrointestinal Cancer-Colorectal and Anal

 Efficacy and safety of fruquintinib plus trifluridine/tipiracil (TAS-102) as     Jianjun Peng,                                                                   #3536 (https://meetings.asco.org/abstracts-presentations/234177)
 third-line treatment in patients with metastatic colorectal adenocarcinoma:

 Results from a single arm, phase 2, multicenter study                            The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China         Poster Session - Gastrointestinal Cancer - Colorectal and Anal

 A phase II study to evaluate the efficacy and safety of fruquintinib combined    Lu Wang, Zhang Ti,                                                              #3543 (https://meetings.asco.org/abstracts-presentations/237050)
 with tislelizumab and Hepatic arteryinfusion chemotherapy (HAIC) for advanced

 colorectal cancer liver metastases: An updated analysis of survival              Fudan University Shanghai Cancer Center, Shanghai, China                        Poster Session - Gastrointestinal Cancer - Colorectal and Anal

 Fruquintinib combined with sintilimab and SOX as conversion therapy for          Suxia Luo, Fei Ma,                                                              #e16021 (https://meetings.asco.org/abstracts-presentations/235778)
 unresectable locally advanced or metastatic gastric/gastroesophageal junction

 adenocarcinoma (GC/GEJC): A single-arm, open-label, phase 2 clinical trial       Henan Cancer Hospital/Affiliated Cancer Hospital of Zhengzhou University,       Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and

                                                                                Zhengzhou, China                                                                Hepatobiliary

 Short-course radiotherapy (SCRT) followed by fruquintinib plus adebrelimab and   Tao Zhang, Zhenyu Lin,                                                          TPS3643 (https://meetings.asco.org/abstracts-presentations/238383)
 CAPOX in the total neoadjuvant therapy of locally advanced rectal cancer

 (LARC): a multicenter, single-arm, open-label, phase II study                    Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of   Poster Session: Gastrointestinal Cancer - Colorectal and Anal

                                                                                Science and Technology, Wuhan, China

 Fruquintinib plus capecitabine versus capecitabine as first-line maintenance     Junjie Peng, Wenhua Li,                                                         #3567 (https://meetings.asco.org/abstracts-presentations/237080)
 treatment of metastatic colorectal cancer (mCRC): Update results from the

 randomized, controlled, phase Ib/II study                                        Fudan University Shanghai Cancer Center, Shanghai, China                        Poster Session: Gastrointestinal Cancer - Colorectal and Anal

 Efficacy and safety of fruquintinib plus investigator's choice of chemotherapy   Yongshun Chen, Wensi Zhao,                                                      #3571 (https://meetings.asco.org/abstracts-presentations/237084)
 as second-line therapy in metastatic colorectal cancer: updated results of a

 multicenter, single-arm, phase 2 trial                                           Renmin Hospital of Wuhan University, Wuhan, China                               Poster Session: Gastrointestinal Cancer - Colorectal and Anal

 Comparative analysis of first-line therapy with fruquintinib plus chemotherapy   Fuxiang Zhou, Wenbo Wang,                                                       #3591 (https://meetings.asco.org/abstracts-presentations/237112)
 versus standard therapy in advanced metastatic colorectal cancer (mCRC): A

 prospective cohort study compared with propensity score matching (PSM) cohort    Zhongnan Hospital of Wuhan University, Wuhan, China                             Poster Session: Gastrointestinal Cancer -Colorectal and Anal

 Efficacy and safety of fruquintinib-based treatment in patients with             Lu Xie, Binghao Li,                                                             #11528 (https://meetings.asco.org/abstracts-presentations/233338)
 refractory bone and soft tissue sarcomas after developing resistance to

 several TKIs: A multi-centered retrospective study                               Peking University People's Hospital, Beijing, China; The Second Affiliated      Poster Session: Sarcoma

                                                                                Hospital Zhejiang University, Hangzhou, China

 Disitamab vedotin combined with fruquintinib in patients with HER2-expressing    Hui Xu,                                                                         #e15003 (https://meetings.asco.org/abstracts-presentations/235509)
 or HER2 mutation/amplified metastatic colorectal cancer refractory to at least

 two standard regimens: A prospective, exploratory, single-arm study              Zhongnan Hospital of Wuhan University. Wuhan, China                             Publication Only: Developmental Therapeutics - Molecularly Targeted Agents and

                                                                                                                                                                Tumor Biology

 Surufatinib combined with TAS-102 in third- or later-line therapy of patients    Dongsheng Zhang,                                                                #e16297 (https://meetings.asco.org/abstracts-presentations/235726)
 with metastatic pancreatic cancer (mPDAC): an open-Label, single-Arm, phase II

 Study                                                                            Sun Yat-sen University Cancer Center, Guangzhou, China                          Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and

                                                                                                                                                                Hepatobiliary

 Surufatinib monotherapy or combined with vinorelbine as a late-line therapy in   Yanfang Zheng,                                                                  #e20543 (https://meetings.asco.org/abstracts-presentations/232303)
 patients with refractory advanced non-small cell lung cancer (NSCLC)

                                                                                Affiliated Cancer Hospital and Institute of Guangzhou Medical University,       Publication Only: Lung Cancer - Non-Small Cell Metastatic
                                                                                  Guangzhou, China

 Updated efficacy and safety results from the phase Ib/II study of surufatinib    Liangjun Zhu, Sheng Li,                                                         #e15547 (https://meetings.asco.org/abstracts-presentations/237501)
 combined with camrelizumab and chemotherapy in patients with advanced

 colorectal cancer                                                                Jiangsu Cancer Hospital, Nanjing, China                                         Publication Only: Gastrointestinal Cancer - Colorectal and Anal

 Phase II study to evaluate surufatinib in patients with osteosarcoma and soft    Xing Zhang,                                                                     #11539 (https://meetings.asco.org/abstracts-presentations/233333)
 tissue sarcoma who have failed in standard chemotherapy: updated analysis

                                                                                Sun Yat-sen University Cancer Center, Guangzhou, China                          Poster Session: Sarcoma

 Efficacy and safety of Surufatinib combined with EP regimen and Serplulimab in   Tao Zhang, Zhenyu Lin,                                                          #e15123 (https://meetings.asco.org/abstracts-presentations/235571)
 first-line treatment of NEC

                                                                                Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of   Publication Only: Developmental Therapeutics - Molecularly Targeted Agents and
                                                                                  Science and Technology, Wuhan, China                                            Tumor Biology

 Performance of surufatinib in treating advanced neuroendocrine neoplasms:        Qing Zhai, Linhui Zhu,                                                          #e15124 (https://meetings.asco.org/abstracts-presentations/235573)
 Insights from a real-world study

                                                                                Fudan University Shanghai Cancer Center; Shanghai Medical College, Fudan        Publication Only: Developmental Therapeutics - Molecularly Targeted Agents and
                                                                                  University, Shanghai, China                                                     Tumor Biology

 Epidemiological investigation of neuroendocrine differentiation in carcinomas:   Susheng Shi, Yaru Wen,                                                          #e16375 (https://meetings.asco.org/abstracts-presentations/235918)
 Focus on pancreatic and cholangiocarcinoma cohorts

                                                                                Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China             Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and

                                                                               Hepatobiliary

 Efficacy and safety of surufatinib, toripalimab, nab-paclitaxel in combination   Fang Liu, Xiang Huang,                                                          #e16047 (https://meetings.asco.org/abstracts-presentations/235921)
 with radiotherapy or surgery in the first-line treatment of esophageal

 squamous cell cancer: A single-centered prospective clinical trial               Chinese PLA General Hospital, Beijing, China                                    Publication Only: Gastrointestinal Cancer - Gastroesophageal, Pancreatic, and

                                                                               Hepatobiliary

 Efficacy and safety of second-line treatment with surufatinib for                Libo Chen, Yang Wang,                                                           #e15127 (https://meetings.asco.org/abstracts-presentations/235597)
 anlotinib-resistant radioiodine-refractory differentiated thyroid cancer: An

 exploratory multicenter study                                                    Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University    Publication Only: Developmental Therapeutics - Molecularly Targeted Agents and

                                                                                School of Medicine, Shanghai, China                                             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 (http://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 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 (mailto: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
                                                                       (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                    +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                       (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon       +44 (20) 7886 2500

 

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