TIDMHCM
Hutchmed (China) Limited
26 May 2023
Press Release
HUTCHMED Highlights Presentations at the 2023 ASCO Annual
Meeting
Hong Kong, Shanghai & Florham Park, NJ - Friday, May 26,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new and updated clinical data related
to HUTCHMED's novel investigational cancer therapies fruquintinib,
surufatinib and HMPL-453 in 21 abstracts that will be presented at
the upcoming American Society of Clinical Oncology (ASCO) Annual
Meeting, taking place June 2-6, 2023 in Chicago, IL and online.
Fruquintinib: further analyses from the FRESCO-2 study and
exploratory combination studies
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptor ("VEGFR")-1, -2 and
-3.[1] Fruquintinib has been generally well tolerated in patients
to date and is being investigated as a single agent and in
combination with other anti-cancer therapies. 13 presentations and
publications, including several investigator-initiated-trials
("IITs"), are listed in the table below.
Additional FRESCO-2 analyses: New analyses from the FRESCO-2
multi-regional clinical trial (MRCT) are being presented. FRESCO-2
is a key study supporting ongoing and upcoming submissions to the
U.S., European and Japanese regulatory authorities for the
treatment of previously treated metastatic colorectal cancer
("CRC"). FRESCO-2 results were first presented at the European
Society for Medical Oncology Congress 2022. These new analyses add
to the understanding of fruquintinib efficacy by specific lines of
therapy as well as adverse events of special interest ("AESI"). In
subgroup analyses by prior lines of therapies up to six or more and
by prior treatment with approved agents, fruquintinib improved
overall survival ("OS") and progression free survival ("PFS") for
all subgroups and prior therapies, consistent with those of the
intent-to-treat ("ITT") population. Furthermore, during the study
AESIs led to low rates of dose reduction (13.6% for patients who
received fruquintinib vs 0.9% for patients who received placebo)
and dose discontinuation (8.3% for patients who received
fruquintinib vs 6.1% for patients who received placebo).
CRC real-world data: Results from a prospective, 3,005-patient
Phase IV study to evaluate the safety of fruquintinib in real-world
clinical practice in China are consistent with the fruquintinib
safety profile observed in existing clinical studies, with no new
or significant safety signals identified.
PD-1 combination in ccRCC: PFS results from an exploratory study
of the fruquintinib and sintilimab (an anti-programmed cell death
protein-1 ["PD-1"] antibody) combination in metastatic clear cell
renal cell carcinoma ("ccRCC") are available with longer term
follow-up. At data cut-off on November 30, 2022, median PFS was
15.9 months in 20 previously treated patients. Median PFS was not
reached when results from this study were initially presented at
the 2021 Chinese Society of Clinical Oncology Annual Meeting (data
cut-off on August 31, 2021). No new safety signals were observed. A
Phase II/III trial of fruquintinib in combination with sintilimab
as second-line treatment for locally advanced or metastatic ccRCC
was initiated in October 2022 (NCT05522231).
IIT in 2L MSS CRC: A number of IITs are being presented,
including initial results of an IIT for fruquintinib in combination
with investigator's choice of chemotherapy in second-line
metastatic CRC with microsatellite-stable (MSS) phenotype. At
median follow up of 8.4 months, median PFS was not reached in 31
efficacy evaluable patients, disease control rate (DCR) was 90.3%
and objective response rate (ORR) was 48.4%. Five patients received
reduced doses of fruquintinib.
Surufatinib: exploratory results in combination with other
agents
Surufatinib is a small-molecule inhibitor of VEGFR-1, -2 and -3,
fibroblast growth factor receptor ("FGFR")-1 and colony-stimulating
factor 1 receptor (CSF-1R). Seven related presentations and
publications, including IITs, are listed in the table below.
PD-1 combinations: We conducted an open-label, multi-cohort,
single-arm Phase II study of surufatinib plus toripalimab (an
anti-PD-1 antibody) in several advanced solid tumors. We reported
the results from the advanced thyroid cancer and endometrial cancer
cohorts (NCT04169672). Amongst efficacy evaluable radioactive
iodine-refractory differentiated thyroid cancer patients, median
PFS was 10.9 months and median OS was not reached (median follow-up
duration was 22.1 months). Amongst efficacy evaluable endometrial
cancer patients, median PFS was 5.4 months and 12-month OS rate was
71.0% (median follow-up duration was 16.8 months). In both cohorts,
the combination showed a tolerable safety profile.
Combo IITs: A number of IITs are being presented for surufatinib
in combination with other agents, including with chemotherapy as
well as with camrelizumab (an anti-PD-1 antibody) plus different
chemotherapy regimens.
Preliminary results in an ongoing IIT in treatment of patients
with naïve metastatic pancreatic adenocarcinoma (PDAC) showed
median PFS of 8.8 months in patients who received a combination of
surufatinib, camrelizumab, nab-paclitaxel and S-1, compared to 5.8
months in patients who received gemcitabine in combination with
nab-paclitaxel. Markers of immune cells were observed in an
analysis of tissue samples from 13 (out of 20) patients who
received S--1 in combination with surufatinib, camrelizumab and
nab-paclitaxel. The combination safety profiles were
manageable.
The IIT in previously treated CRC study completed the dose
escalation phase of the study in 12 patients and enrolled a further
36 patients in the dose expansion phase of the study. The
investigators found the combination of surufatinib with
camrelizumab, irinotecan and GM-CSF to be well tolerated with a
manageable safety profile. Median PFS was 7.2 months (95% CI
3.7-10.7).
The IIT in previously treated, advanced driver-gene negative,
non-squamous, non-small cell lung cancer ("NSCLC") in combination
with chemotherapy. This study complements Phase II results
previously presented for the surufatinib and toripalimab
combination in patients with treatment naïve advanced NSCLC with
positive PD-L1 expression.
HMPL-453: first in human results
FGFRs regulate numerous cellular processes. Dysregulation of
FGFR signaling due to receptor fusion, mutation or amplification is
observed across multiple cancer types, making activated FGFRs an
important therapeutic target. HMPL-453 is a highly potent and
selective inhibitor of FGFR-1, -2, and -3. Preclinical data
presented at the American Association for Cancer Research Annual
Meeting 2023 (AACR 2023) showed that it has strong activity against
FGFR-deregulated tumors, supporting investigation in patients with
FGFR alterations (such as fusion and mutation) either as a single
agent or in combination with PD-1 blockade.
Here we present first-in-human data for HMPL-453 in patients
with previously treated advanced intrahepatic cholangiocarcinoma
(IHCC) harboring FGFR2 fusions. A Phase II registration intent
cohort is currently enrolling such patients (NCT04353375).
Further details including the full abstracts are available at
meetings.asco.org , as summarized below.
ABSTRACT PRESENTATION DETAILS
Abstract title Presenter / Lead author Presentation details
====================================== ====================================== ======================================
FRUQUINTINIB
====================================== ====================================== ======================================
Subgroup analyses of safety and Arvind Dasari, MD Anderson Cancer Abstract # 3604
efficacy by number and types of prior Center Poster Session
lines of treatment Gastrointestinal Cancer-Colorectal and
in FRESCO-2, a global phase III study Anal
of fruquintinib in patients with Monday, June 5, 2023, 8 am CDT, Hall A
refractory metastatic
colorectal cancer
====================================== ====================================== ======================================
Analysis of fruquintinib adverse Cathy Eng, Vanderbilt-Ingram Cancer Abstract # 3601
events of special interest from phase Center Poster Session
3 of the FRESCO-2 Gastrointestinal Cancer-Colorectal and
study Anal
Monday, June 5, 2023, 8 am CDT, Hall A
====================================== ====================================== ======================================
A phase IV study to evaluate the Jin Li, Tongji University Shanghai Abstract # e15568
safety of fruquintinib in Chinese East Hospital Publication Only
real-world clinical practice Gastrointestinal Cancer-Colorectal and
Anal
====================================== ====================================== ======================================
Fruquintinib plus sintilimab in Dingwei Ye, Fudan University Shanghai Abstract # e16514
patients with either treatment-naive Cancer Center Publication Only
or previously first Genitourinary Cancer-Kidney and
line treated metastatic clear-cell Bladder
renal cell carcinoma (ccRCC): Results
from a multicenter,
single-arm phase 2 study
====================================== ====================================== ======================================
Efficacy and safety of fruquintinib Wensi Zhao, Renmin Hospital of Wuhan Abstract # 3582
plus investigator's choice of University Poster Session
chemotherapy as second-line Gastrointestinal Cancer-Colorectal and
therapy in metastatic colorectal Anal
cancer: A multicenter, single-arm Monday, June 5, 2023, 8 am CDT, Hall A
phase 2 trial
====================================== ====================================== ======================================
Fruquintinib plus oxaliplatin combined Liucheng Wu, Guangxi Medical Abstract # e16063
with S-1 (SOX) as neoadjuvant therapy University Cancer Hospital Publication Only
for locally Gastrointestinal
advanced gastric adenocarcinoma Cancer-Gastroesophageal, Pancreatic,
(FRUTINEOGA): a multicenter, phase II and Hepatobiliary
study.
====================================== ====================================== ======================================
Association of neutrophil/lymphocyte Zhuqing Liu, Tongji University School Abstract # e14610
ratio and IFN-<GAMMA> with clinical of Medicine Publication Only
response and survival Developmental
in patients with MSS/pMMR mCRC treated Therapeutics-Immunotherapy
with anti-PD-1 and VEGF inhibitors
====================================== ====================================== ======================================
Efficacy and safety of radiation Zhenyu Lin, Tongji Medical College Abstract # e15559
therapy combined with anti-angiogenic Publication Only
agents and immunotherapy Gastrointestinal Cancer-Colorectal and
for MSS/pMMR metastatic colorectal Anal
cancer: A real-world study
====================================== ====================================== ======================================
A phase II study of fruquintinib in Zhiguo Luo, Fudan University Shanghai Abstract # e23547
the first- (1L) or second-line (2L) Cancer Center Publication Only
treatment of unresectable Sarcoma
metastatic soft tissue sarcoma
====================================== ====================================== ======================================
Quality of life, effectiveness, and Jun Zhang, Reijin Hospital Abstract # e15557
compliance of fruquintinib in the Publication Only
treatment of metastatic Gastrointestinal Cancer-Colorectal and
colorectal cancer: Results from a Anal
prospective real-world study.
====================================== ====================================== ======================================
Fruquintinib versus fruquintinib Lina He, Shanghai Jiao Tong University Abstract # e15592
combined with PD-1 inhibitors for Publication Only
metastatic colorectal Gastrointestinal Cancer-Colorectal and
cancer: Real-world data Anal
====================================== ====================================== ======================================
Phase II study of fruquintinib as Pengfei Zhang, West China Hospital Abstract # e16161
second or further-line therapy for Publication Only
patients with advanced Gastrointestinal
biliary tract cancer Cancer-Gastroesophageal, Pancreatic,
and Hepatobiliary
====================================== ====================================== ======================================
A phase I/IIa study of cetuximab Yong Li, Traditional Chinese Medicine Abstract # e15558
combined with fruquintinib in the Hospital of Guangdong Publication Only
previously treated RAS/BRAF Gastrointestinal Cancer-Colorectal and
wild-type metastatic colorectal Anal
cancer: Results of the CEFRU study
====================================== ====================================== ======================================
SURUFATINIB
====================================== ====================================== ======================================
A multicenter, single-arm phase 2 Dongmei Ji, Fudan University Shanghai Abstract # 6089
study of surufatinib plus toripalimab Cancer Center Poster Session
for patients with Head and Neck Cancer
locally advanced or metastatic Monday, June 5, 2023, 1:15 pm CDT,
radioactive iodine-refractory Hall A
differentiated thyroid cancer
====================================== ====================================== ======================================
A multicenter, single-arm, phase 2 Guangwen Yuan, Cancer Hospital Chinese Abstract # 5609
study of surufatinib plus toripalimab Academy of Medical Sciences Poster Session
for patients with Gynecologic Cancer
advanced endometrial cancer Monday, June 5, 2023, 1:15 pm CDT,
Hall A
====================================== ====================================== ======================================
A phase 1b/2 study of surufatinib plus Guanghai Dai, The Fifth Medical Center Abstract # 4142
camrelizumab, nab-paclitaxel, and S-1 of the PLA General Hospital Poster Session
(NASCA) as first-line Gastrointestinal
therapy for metastatic pancreatic Cancer-Gastroesophageal, Pancreatic,
adenocarcinoma (mPDAC) and Hepatobiliary
Monday, June 5, 2023, 8:00 am CDT,
Hall A
====================================== ====================================== ======================================
A phase Ib/II study to evaluate Sheng Li, Department of Oncology, Abstract # 3555
surufatinib combined with camrelizumab Jiangsu Cancer Hospital Poster Session
and chemotherapy in Gastrointestinal Cancer-Colorectal and
the second-line treatment of advanced Anal
colorectal cancer: Phase Ib results Monday, June 5, 2023, 8 am CDT, Hall A
====================================== ====================================== ======================================
Phase 1b/2 study of surufatinib in Wei Jiang, Guangxi Medical University Abstract # e21087
combination with docetaxel as Cancer Hospital Publication Only
second-line treatment of Lung Cancer-Non-Small Cell Metastatic
advanced driver-gene negative
non-squamous non-small cell lung
cancer (NSCLC)
====================================== ====================================== ======================================
Pathologic exploration of Yaru Wen, Cancer Hospital Chinese Abstract # e16238
neuroendocrine differentiation in Academy of Medical Sciences Publication Only
carcinomas Gastrointestinal
Cancer-Gastroesophageal, Pancreatic,
and Hepatobiliary
====================================== ====================================== ======================================
A phase II study of surufatinib in Xing Zhang, Sun Yat-sen University Abstract # e23540
patients with osteosarcoma and soft Cancer Center Publication Only
tissue sarcoma who Sarcoma
have failed in standard chemotherapy
====================================== ====================================== ======================================
HMPL-453
====================================== ====================================== ======================================
A phase 2 study of HMPL-453, a Jianming Xu, Fifth Medical Center, Abstract # e16118
selective FGFR tyrosine kinase Chinese PLA General Hospital Publication Only
inhibitor (TKI), in patients Gastrointestinal
with previously treated advanced Cancer-Gastroesophageal, Pancreatic,
cholangiocarcinoma containing FGFR2 and Hepato-biliary
fusions
====================================== ====================================== ======================================
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 oncology drugs now approved and
marketed in China. 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 its expectations regarding the therapeutic
potential of fruquintinib, surufatinib, and HMPL-453, the further
clinical development for fruquintinib, surufatinib, and HMPL-453,
its expectations as to whether any studies on fruquintinib,
surufatinib and HMPL-453 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
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-453, including as a combination therapy, 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
market of fruquintinib, surufatinib and HMPL-453 for a targeted
indication; the sufficiency of funding; and the impact of the
COVID-19 pandemic on general economic, regulatory and political
conditions. 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.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 306 4490
Media Enquiries
Americas - Brad Miles, Solebury Strategic Communications +1 (917) 570 7340 (Mobile) / bmiles@s oleburystrat .com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile) / HUTCHMED@fticonsulting.com
Asia - Zhou Yi, Brunswick +852 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure
Gordon +44 (20) 7886 2500
[1] Sun Q, et al. (2014) Discovery of fruquintinib, a potent and
highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine
kinases for cancer therapy, Cancer Biol Ther. 2014 15:12,
1635-1645. Doi: 10.4161/15384047.2014.964087
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