TIDMHCM
Hutchmed (China) Limited
01 December 2023
Press Release
HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO
Asia and ESMO Immuno-Oncology Congresses
Hong Kong, Shanghai & Florham Park, NJ - Friday, December 1,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM; HKEX:
13) today highlights that new clinical data from several ongoing
studies with HUTCHMED investigational drug candidates fruquintinib,
surufatinib and HMPL-295, which will be presented at the upcoming
European Society for Medical Oncology ("ESMO") Asia Congress,
taking place on December 1-3, 2023 in Singapore, and the ESMO
Immuno-Oncology Congress, taking place on December 6--8, 2023 in
Geneva, Switzerland.
HMPL-295:
Title: A first in human, open-label, dose-escalation study
of ERK1/2 inhibitor HMPL-295 in patients with advanced
solid tumors
Lead Author: Rujiao Liu, Department of Medical Oncology, Fudan
University Shanghai Cancer Center, Shanghai, China
Type: Oral presentation
Abstract # & 77MO
Link:
Session & Location: ESMO Asia - Developmental and precision medicine (ID
29), Hall 402
Date & Time: Friday, December 1, 2023, 11:50 am Singapore time
This presentation will report data from a multi-center,
open-label clinical trial to evaluate safety, tolerability,
pharmacokinetics and preliminary efficacy profile of HMPL-295, and
to determine the maximum tolerated dose ("MTD") and recommended
Phase II dose in patients with advanced malignant solid tumors. The
continuous-administration MTD was determined to be 50 mg QD, and
intermittent administration studies are ongoing.
HMPL-295 is an investigational, selective, oral inhibitor of
extracellular signal-regulated kinase 1 & 2 (ERK1/2), which is
a downstream component of the RAS-MAPK pathway signaling cascade.
The investigational compound has the potential to address intrinsic
or acquired resistance from upstream mechanisms such as RAS, RAF
and MEK. HMPL-295 is one of several investigational compounds
discovered by HUTCHMED that target the RAS-MAPK pathway.
Fruquintinib:
Title: Fruquintinib plus sintilimab in advanced cervical
cancer patients: Results from a multicenter, single-arm
Phase II study
Lead Author: Xiaotian Han, Oncologic Gynecology Department, Fudan
University Shanghai Cancer Center, Shanghai, China
Type: Oral presentation
Abstract # & 289MO
Link:
Session & Location: ESMO Asia - Gynaecological cancers (ID 28), Hall 401
Date & Time: Friday, December 1, 2023, 11:25 am Singapore time
Title: Fruquintinib plus sintilimab in patients with advanced
non-small cell lung cancer ("NSCLC") with PD-L1 positive
expression: A multicenter, single-arm phase II study
Lead Author: Shun Lu, Shanghai Lung Cancer Center, Shanghai Chest
Hospital, School of Medicine, Shanghai Jiaotong University,
Shanghai, China
Abstract # &
Link: 496P
Session & Location: ESMO Asia - Poster Display (ID78), Exhibition area
Date & Time: Saturday, December 2, 2023, 5:50 pm Singapore time
These presentations will report results from the cervical cancer
and NSCLC patient cohorts of the basket clinical trial in China of
fruquintinib plus sintilimab. This trial is an open-label,
multi-center, non-randomized, Phase study to assess the safety and
efficacy of fruquintinib in combination with sintilimab in patients
with advanced cervical cancer, endometrial cancer ("EMC"), gastric
cancer (GC), hepatocellular carcinoma (HCC), NSCLC or renal cell
carcinoma ("RCC"). Data from the EMC and RCC cohorts of this trial
led to the initiation of registration enabling programs. This
combination treatment showed promising antitumor activity in
advanced cervical cancer and NSCLC patients, particularly for
patients with PD-L1 positive status. This combination treatment
also showed manageable toxicity profiles consistent with that seen
in other cohorts.
Fruquintinib is a selective oral inhibitor of vascular
endothelial growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR
inhibitors play a pivotal role in blocking tumor angiogenesis.
Fruquintinib was designed to have enhanced selectivity that limits
off-target kinase activity, allowing for high drug exposure,
sustained target inhibition, and flexibility for the potential use
as part of combination therapy. Fruquintinib has demonstrated a
manageable safety profile and is being investigated in combination
with other anti-cancer therapies including the approved PD-1
inhibitor, sintilimab.
Title: Efficacy and safety of fruquintinib + best supportive
care (BSC) vs placebo + BSC in refractory metastatic
colorectal cancer: Asian vs non-Asian outcomes in
FRESCO-2
Lead Author: Daisuke Kotani, National Cancer Center Hospital East
Kashiwa, Japan
Abstract # &
Link: 93P
Session & Location: ESMO Asia - Poster Display (ID78), Exhibition area
Date & Time: Saturday, December 2, 2023, 5:50 pm Singapore time
This presentation will report efficacy and safety data according
to race for Asian and non-Asian patient subgroups from the FRESCO-2
study. FRESCO-2 is a global Phase III multi-regional clinical trial
(MRCT) conducted in the U.S., Europe, Japan and Australia
investigating fruquintinib plus best supportive care ("BSC") vs.
placebo plus BSC in patients with previously treated metastatic
colorectal cancer. There was a clinically meaningful improvement in
overall survival (OS) and progression-free survival (PFS) in both
Asian and non-Asian patients. The safety and efficacy subgroup
analysis results were consistent with the overall FRESCO-2
population and with the established monotherapy profile of
fruquintinib.
Investigator-initiated studies presentations:
Abstract title Presenter / Lead Presentation details
author
=================================== =============================== =========================
ESMO Asia Congress 2023
===============================================================================================
Tyrosine kinase Inhibitor Jingdong Zhang, Qian 96P
(TKI) plus PD-1 blockade in Dong, Poster presentation
TKI-responsive MSS/pMMR metastatic Medical Oncology (Gastrointestinal
colorectal adenocarcinoma: Department of Gastrointestinal tumours, colorectal)
updated results of TRAP study Cancer, Liaoning Saturday, December
Cancer Hospital & 2, 2023
Institute, Shenyang,
China
=================================== =============================== =========================
Efficacy and safety of fruquintinib Lin Yang, Xiaoting 186P
with Nab-Paclitaxel in Advanced Ma, Poster presentation
G/GEJ cancer after exposure Department of Medical (Gastrointestinal
to immune checkpoint inhibitors: Oncology, Chinese tumours, non-colorectal)
A single-center prospective Academy of Medical Saturday, December
clinical trial Sciences and Peking 2, 2023
Union Medical College
- National Cancer
Center, Beijing,
China
=================================== =============================== =========================
ESMO Immuno-Oncology Congress 2023
===============================================================================================
A single-center, Phase II Li Zhang, Wenfeng 74P
study of surufatinib combined Fang, Poster Display
with toripalimab, pemetrexed, Department of Medical Thursday, December
and platinum in patients with Oncology, Sun Yat-sen 7, 2023
advanced non-squamous non-small University Cancer
cell lung cancer (nsq-NSCLC) Center, Guangzhou,
China
=================================== =============================== =========================
Surufatinib plus toripalimab Li Zhang, Wenfeng 124P
combined with etoposide and Fang, Poster Display
cisplatin in patients with Department of Medical Thursday, December
advanced naïve small cell Oncology, Sun Yat-sen 7, 2023
lung cancer (SCLC) - Updated University Cancer
results of a phase Ib/II trial Center, Guangzhou,
China
=================================== =============================== =========================
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery and 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 it 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.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding the timing and outcome of clinical studies and the
sufficiency of clinical data to support approval of fruquintinib,
surufatinib and HMPL-295 for the treatment of patients with
colorectal cancer or other indications in jurisdictions such as
China, the U.S., the E.U. or Japan, its potential to gain approvals
from regulatory authorities on an expedited basis or at all; the
efficacy and safety profile of fruquintinib, surufatinib and
HMPL-295; assumptions regarding 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;
the sufficiency of funding; and the impact of COVID-19 or other
infectious diseases on general economic, regulatory and political
conditions. 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 / +1 973 306 4490 / 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
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