HUTCHMED Highlights Clinical Data to be Presented at 2023 ESMO Asia and ESMO Immuno-Oncology Congresses
01 Dezember 2023 - 1:00AM
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 # &
Link: |
77MO |
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 # &
Link: |
289MO |
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 ІІ 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 author |
Presentation details |
ESMO Asia Congress 2023 |
Tyrosine kinase Inhibitor (TKI) plus PD-1 blockade in
TKI-responsive MSS/pMMR metastatic colorectal adenocarcinoma:
updated results of TRAP study |
Jingdong Zhang, Qian Dong,Medical Oncology Department of
Gastrointestinal Cancer, Liaoning Cancer Hospital & Institute,
Shenyang, China |
96PPoster presentation(Gastrointestinal tumours,
colorectal)Saturday, December 2, 2023 |
Efficacy and safety of fruquintinib with Nab-Paclitaxel in
Advanced G/GEJ cancer after exposure to immune checkpoint
inhibitors: A single-center prospective clinical
trial |
Lin Yang, Xiaoting Ma,Department of Medical Oncology, Chinese
Academy of Medical Sciences and Peking Union Medical College –
National Cancer Center, Beijing, China |
186PPoster presentation(Gastrointestinal tumours,
non-colorectal)Saturday, December 2, 2023 |
|
ESMO Immuno-Oncology Congress 2023 |
A single-center, Phase II study of surufatinib combined
with toripalimab, pemetrexed, and platinum in patients with
advanced non-squamous non-small cell lung cancer
(nsq-NSCLC) |
Li Zhang, Wenfeng Fang, Department of Medical Oncology, Sun Yat-sen
University Cancer Center, Guangzhou, China |
74PPoster DisplayThursday, December 7, 2023 |
Surufatinib plus toripalimab combined with etoposide and
cisplatin in patients with advanced naïve small cell lung cancer
(SCLC) – Updated results of a phase Ib/II trial |
Li Zhang, Wenfeng Fang, Department of Medical Oncology, Sun Yat-sen
University Cancer Center, Guangzhou, China |
124PPoster DisplayThursday, December 7, 2023 |
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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