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
13 12월 2023 - 9:00AM
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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