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
2020.2 In Japan, CRC is the most common cancer, with an estimated
147,000 new cases and 59,000 deaths in 2020.2
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®. It
was included in the China National Reimbursement Drug List (NRDL)
in January 2020. ELUNATE® 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 study3, 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 fruquintinib
combined with paclitaxel for second-line treatment of advanced
gastric or esophagogastric junction (“GEJ”) adenocarcinoma. 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® 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, Solebury Trout |
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.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 9783 6894 (Mobile)
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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