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 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) Patients (Pts) with pMMR Status: Results
From a Multicenter, Single-Arm Phase 2 Study |
Xiaohua Wu, Fudan University Shanghai Cancer Center, Shanghai,
China |
#5619Poster 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. |
#3579Poster Session - Gastrointestinal Cancer — Colorectal and
Anal |
Fruquintinib in Refractory Metastatic Colorectal
Cancer |
Cathy Eng, Vanderbilt-Ingram Cancer Center, U.S. |
LinkEducation 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 |
LinkEducation 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 |
#e15109Publication 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 |
#e15112Publication 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 |
#e15570Publication 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 |
#3561Poster 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 |
#3536Poster 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 |
#3543Poster 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 |
#e16021Publication 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 |
TPS3643Poster 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 |
#3567Poster 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 |
#3571Poster 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 |
#3591Poster 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 |
#11528Poster 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 |
#e15003Publication 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 |
#e16297Publication 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 |
#e20543Publication 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 |
#e15547Publication 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 |
#11539Poster 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 |
#e15123Publication 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 |
#e15124Publication 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 |
#e16375Publication 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 |
#e16047Publication 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 |
#e15127Publication Only: Developmental Therapeutics — Molecularly
Targeted Agents and Tumor Biology |
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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.
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.