TIDMHCM
Hutchmed (China) Limited
13 December 2023
Press Release
HUTCHMED Announces that it has Completed Enrollment of a Phase
II/III Trial of Fruquintinib in Combination with Sintilimab for
Advanced Renal Cell Carcinoma in China
Hong Kong, Shanghai & Florham Park, NJ - Wednesday, December
13, 2023: HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13)
("HUTCHMED") today announces that it has completed enrollment of
its Phase II/III trial of fruquintinib in combination with
sintilimab as second-line treatment for locally advanced or
metastatic renal cell carcinoma ("RCC") in China.
The study is a randomized, open-label, active-controlled study
to evaluate the efficacy and safety of fruquintinib in combination
with sintilimab versus axitinib or everolimus monotherapy for the
second-line treatment of advanced RCC. The primary endpoint is
progression free survival ("PFS") per RECIST 1.1 as assessed by
blinded independent central review (BICR). The secondary endpoints
include objective response rate ("ORR"), disease control rate
("DCR"), duration of response ("DoR"), time to response (TTR),
overall survival ("OS"), safety, and quality of life. A total of
234 patients have been enrolled in the study. The leading principal
investigators are Dr Dingwei Ye of Fudan University Shanghai Cancer
Center and Dr Zhisong He of Peking University First Hospital.
Additional details may be found at clinicaltrials.gov, using
identifier NCT05522231.
The first patient in China received the first dose on October
27, 2022 and HUTCHMED expects to announce topline results from the
study around year end 2024. If favorable, the results would enable
a New Drug Application submission to China's National Medical
Products Administration ("NMPA").
About Kidney Cancer and RCC
It is estimated that approximately 430,000 new patients were
diagnosed with kidney cancer worldwide in 2020. [1] In China, an
estimated 74,000 new patients were diagnosed with kidney cancer in
2020. [2] Approximately 90% of kidney tumors are RCC.
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:
About Fruquintinib and Second-line treatment of RCC
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.
The U.S. Food and Drug Administration ("FDA") has approved five
immune-oncology combination therapies for first-line treatment of
advanced RCC, however, no immune-oncology combination therapies
have been approved in China, indicating an unmet medical need in
these settings.
As presented at the 2023 American Society of Clinical Oncology
Annual Meeting (ASCO), a proof of concept study of fruquintinib
plus sintilimab demonstrated promising efficacy and tolerable
safety profile in this setting. At the data cutoff date of November
30, 2022, all 20 enrolled previously treated patients were efficacy
evaluable, and median follow-up duration was 23.3 months. The
confirmed ORR was 60.0% and DCR was 85.0%. Median DoR was 13.9
months and mPFS was 15.9 months. OS was not reached.
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 its expectations regarding the submission of a
NDA for fruquintinib for the treatment of RCC with the NMPA and the
timing of such submission, the therapeutic potential of
fruquintinib for the treatment of patients with RCC 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 timing and outcome of clinical studies and the
sufficiency of clinical data to support NDA approval of
fruquintinib for the treatment of patients with CRC, RCC or other
indications in China or other jurisdictions, its potential to gain
approvals from regulatory authorities on an expedited basis or at
all; the efficacy and safety profile of fruquintinib; HUTCHMED
ability to fund, implement and complete its further clinical
development and commercialization plans for fruquintinib; the
timing of these events; actions of regulatory agencies, which may
affect the initiation, timing and progress of clinical trials or
the regulatory pathway for fruquintinib; and the impact of COVID-19
on general economic, regulatory and political conditions. In
addition, as certain studies rely on the use of other drug products
such as sintilimab as combination therapeutics with fruquintinib,
such risks and uncertainties include assumptions regarding the
safety, efficacy, supply and continued regulatory approval of these
therapeutics. Such forward-looking statements include, without
limitation, statements regarding the plan to develop, manufacture
and commercialize fruquintinib; and HUTCHMED's strategy, goals and
anticipated milestones, business plans and focus. 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.
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
References
[1] The Global Cancer Observatory, kidney cancer fact sheet. https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf. Accessed September 28, 2022.
[2] The Global Cancer Observatory, China fact sheet.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
. Accessed September 30, 2022.
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