TIDMHCM
Hutchmed (China) Limited
19 January 2022
Press Release
HUTCHMED Highlights Fruquintinib Clinical Data to be Presented
at the 2022 ASCO Gastrointestinal Cancers Symposium
Hong Kong, Shanghai & Florham Park, NJ - Wednesday, January
19, 2022: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM;
HKEX: 13) today announces that updated analysis of the ongoing
international Phase I/Ib trial of fruquintinib will be presented at
the upcoming 2022 ASCO Gastrointestinal Cancers Symposium, taking
place on January 20-22, 2022. The meeting will be held virtually
and in person at the Moscone Center in San Francisco, California,
US.
Further details of the presentation are as follows:
Title: Phase I/Ib trial of fruquintinib in patients with advanced
solid tumors: preliminary results of the dose expansion
cohorts in refractory metastatic colorectal cancer
Presenter: Arvind Dasari, MD, MS, MD Anderson Cancer Center
Session: Poster Session C: Cancers of the Colon, Rectum, and Anus
Abstract No.: 93
Date & Time: Saturday, January 22, 2022
Location: Moscone Center - West, Level 1, West Hall and virtually
About Colorectal Cancer ("CRC")
CRC is a cancer that starts in either the colon or rectum. CRC
is the third most common cancer worldwide, estimated to have caused
more than 915,000 deaths in 2020. [1] In the U.S., an estimated
150,000 people were diagnosed with CRC and 53,000 people died from
CRC in 2021. [2] In Europe, CRC is the second most common cancer,
with an estimated 507,000 new cases and 240,000 deaths in 2020.(1)
In Japan, CRC is the most common cancer, with an estimated 147,000
new cases and 59,000 deaths in 2020.(1)
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
VEGFR-1, -2 and -3. VEGFR inhibitors play a pivotal role in
blocking tumor angiogenesis. Fruquintinib was designed to improve
kinase selectivity to minimize off-target toxicities, improve
tolerability and provide more consistent target coverage. The
generally good tolerability in patients to date, along with
fruquintinib's low potential for drug-drug interaction based on
preclinical assessment, suggests that it may also be highly
suitable for combinations with other anti-cancer therapies.
About Fruquintinib Approval in China
Metastatic CRC in China: Fruquintinib was approved for marketing
by the China National Medical Products Administration (NMPA) in
September 2018 and commercially launched in China in late November
2018 under the brand name ELUNATE(R) . It was included in the China
National Reimbursement Drug List (NRDL) in January 2020. ELUNATE(R)
is indicated for the treatment of patients with metastatic CRC who
have been previously treated with fluoropyrimidine, oxaliplatin and
irinotecan, including those who have previously received anti-VEGF
therapy and/or anti-EGFR therapy (RAS wild type). Results of the
FRESCO study [3] , a Phase III pivotal registration trial of
fruquintinib in 416 patients with metastatic CRC in China, were
published in The Journal of the American Medical Association, JAMA,
in June 2018 (clinicaltrials.gov identifier: NCT02314819).
About Fruquintinib Development Beyond CRC Monotherapy
The safety and efficacy of fruquintinib for the following
investigational uses have not been established and there is no
guarantee that it will receive health authority approval or become
commercially available in any country for the uses being
investigated:
Gastric Cancer ("GC") in China : In October 2017, HUTCHMED
initiated the FRUTIGA study, a randomized, double-blind, Phase III
trial evaluating the efficacy and safety of fru quintinib combined
with paclitaxel for second-line treatment of advanced g astric or
esophagogastric junction ("GEJ") a denocarcinoma. The trial is
designed to enroll patients who did not respond to first-line
standard chemotherapy. Subjects receive either fruquintinib
combined with paclitaxel or placebo combined with paclitaxel.
Patients are randomized at a 1:1 ratio and stratified according to
factors such as stomach vs. GEJ tumor type and performance status.
The primary efficacy endpoint is overall survival (OS). Secondary
efficacy endpoints include progression-free survival (as defined by
RECIST 1.1), objective response rate, disease control rate,
duration of response, and quality-of-life score (EORTC QLQ-C30,
version 3.0). Biomarkers related to the antitumor activity of
fruquintinib will also be explored (clinicaltrials.gov identifier:
NCT03223376). In June 2020, HUTCHMED completed a planned interim
data review. Based on the preset criteria, the Independent Data
Monitoring Committee (IDMC) recommended that the trial
continue.
Immunotherapy combinations: HUTCHMED has entered into
collaboration agreements to evaluate the safety, tolerability and
efficacy of fruquintinib in combination with PD-1 monoclonal
antibodies, including with tislelizumab (BGB-A317, developed by
BeiGene, Ltd) and sintilimab (IBI308, developed by Innovent
Biologics, Inc. and marketed as TYVYT(R) in China).
-- Metastatic breast and endometrial cancers in the U.S.:
HUTCHMED initiated this open-label, multi-center, non-randomized,
Phase Ib/II study in the U.S. to assess the safety and efficacy of
fruquintinib in combination with tislelizumab in patients with
advanced, refractory triple negative breast cancer ("TNBC") and
endometrial cancer ("EMC"). This study is being conducted to
investigate if the addition of fruquintinib can potentially induce
activity to immune checkpoint inhibitor therapy in TNBC and EMC.
Additional details of the study may be found at clinicaltrials.gov,
using identifier NCT04577963. Safety and preliminary efficacy of
fruquintinib were demonstrated in advanced solid tumors, including
TNBC, in a Phase I study conducted in China (NCT01645215) and a
Phase I/Ib study is ongoing in the United States (NCT03251378).
-- Gastric, colorectal and non-small cell lung cancers in China
& Korea: BeiGene, Ltd. initiated this open-label, multi-center,
Phase II study to assess the safety and efficacy of fruquintinib in
combination with tislelizumab in patients with advanced or
metastatic, unresectable GC, CRC or non-small cell lung cancer
("NSCLC"). Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT04716634.
-- Solid tumors in China: HUTCHMED initiated this open-label,
multi-center, non-randomized, Phase II study to assess the safety
and efficacy of fruquintinib in combination with sintilimab in
patients with advanced EMC, cervical cancer, CRC, GC,
hepatocellular carcinoma (HCC), NSCLC or renal cell carcinoma
(RCC). Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT03903705. Preliminary
results of certain cohorts were presented at the 2021 American
Society of Clinical Oncology Annual Meeting (ASCO) and the Chinese
Society of Clinical Oncology Annual Meeting (CSCO).
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery, global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. It has more than 4,500 personnel across all
its companies, at the center of which is a team of over 1,400 in
oncology/immunology. Since inception it has advanced 11 cancer drug
candidates from in-house discovery into clinical studies 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 for the treatment of patients with
advanced CRC and the further clinical development of fruquintinib
in this and other indications. Forward-looking statements involve
risks and uncertainties. Such risks and uncertainties include,
among other things, assumptions regarding the sufficiency of
clinical data to support New Drug Application approval of
fruquintinib for the treatment of patients with advanced CRC in the
U.S., Europe, Japan, Australia or other jurisdictions, its
potential to gain expeditious approvals from regulatory
authorities, the safety profile of fruquintinib, HUTCHMED's ability
to fund, implement and complete its further clinical development
and commercialization plans for fruquintinib, the timing of these
events, and the impact of the COVID-19 pandemic on general
economic, regulatory and political conditions. In addition, as
certain studies rely on the use of other drug products such as
paclitaxel, tislelizumab and sintilimab as combination therapeutics
with fruquintinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of these therapeutics. 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, on AIM and on The
Stock Exchange of Hong Kong Limited. 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) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] The Global Cancer Observatory. Accessed September 21,
2021.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html .
Accessed September 21, 2021.
[3] Li J, Qin S, Xu RH, et al. Effect of Fruquintinib vs Placebo
on Overall Survival in Patients With Previously Treated Metastatic
Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA.
2018;319(24):2486-2496. doi:10.1001/jama.2018.7855.
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