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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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