RCS - Hutchmed China Ltd - Clinical Data to be Presented at Congresses
01/12/2023 07:00
For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20231201:nRSA2730Va&default-theme=true
RNS Number : 2730V 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 (https://www.hutch-med.com/) ")
(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
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/572)
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
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/1357)
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
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/1323)
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
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/1236)
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 Jingdong Zhang, Qian Dong, 96P
metastatic colorectal adenocarcinoma: updated results of TRAP study
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/2037)
Medical Oncology Department of Gastrointestinal Cancer, Liaoning Cancer
Hospital & Institute, Shenyang, China Poster presentation
(Gastrointestinal tumours, colorectal)
Saturday, December 2, 2023
Efficacy and safety of fruquintinib with Nab-Paclitaxel in Advanced G/GEJ Lin Yang, Xiaoting Ma, 186P
cancer after exposure to immune checkpoint inhibitors: A single-center
(https://cslide.ctimeetingtech.com/asia2023/attendee/confcal/print/presentation/1145)
prospective clinical trial Department of Medical Oncology, Chinese Academy of Medical Sciences and Peking
Union Medical College - National Cancer Center, Beijing, China Poster 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, Li Zhang, Wenfeng Fang, 74P
pemetrexed, and platinum in patients with advanced non-squamous non-small cell
(https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/print/presentation/229)
lung cancer (nsq-NSCLC) Department of Medical Oncology, Sun Yat-sen University Cancer Center,
Guangzhou, China Poster Display
Thursday, December 7, 2023
Surufatinib plus toripalimab combined with etoposide and cisplatin in patients Li Zhang, Wenfeng Fang, 124P
with advanced naïve small cell lung cancer (SCLC) - Updated results of a
(https://cslide.ctimeetingtech.com/immuno23hybrid/attendee/confcal/print/presentation/275)
phase Ib/II trial Department of Medical Oncology, Sun Yat-sen University Cancer Center,
Guangzhou, China Poster Display
Thursday, 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
(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. 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
(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
This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
or visit
www.rns.com (http://www.rns.com/)
.
RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
. END NRAURSVROBUAOAARecent news on HUTCHMED (China)
See all newsREG - Hutchmed China Ltd - Positive CHMP Opinion for Fruquintinib
AnnouncementREG - Hutchmed China Ltd - Vesting of Awards Under the LTIP
AnnouncementREG - Hutchmed China Ltd - 2023 Annual Report and Notice of AGM
AnnouncementRCS - Hutchmed China Ltd - Data to be Presented at AACR Congress 2024
AnnouncementRCS - Hutchmed China Ltd - HUTCHMED and Innovent Announce NDA Acceptance
Announcement