RCS - Hutchmed China Ltd - Completed Enrollment of Phase II/III Trial

HUTCHMED (China)Announcement

13/12/2023 07:15

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RNS Number : 5223W  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
(https://www.hutch-med.com/) ") 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
(https://clinicaltrials.gov/study/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  (#_edn1) In China, an estimated 74,000 new
patients were diagnosed with kidney cancer in 2020. 2  (#_edn2) 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 (https://www.hutch-med.com/2023-asco-annual-meeting/) 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
(http://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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
                                                                   (mailto: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
                                                                   (mailto:HUTCHMED@fticonsulting.com)
 Zhou Yi, Brunswick                                                +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                                   (mailto:HUTCHMED@brunswickgroup.com)

 Nominated Advisor
 Atholl Tweedie / Freddy Crossley / Daphne Zhang, Panmure Gordon   +44 (20) 7886 2500

 

 

References

 1  (#_ednref1)   The Global Cancer Observatory, kidney cancer fact sheet.
https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf
(https://gco.iarc.fr/today/data/factsheets/cancers/29-Kidney-fact-sheet.pdf) .
Accessed September 28, 2022.

 2  (#_ednref2) The Global Cancer Observatory, China fact sheet.
https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf
(https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf)
. Accessed September 30, 2022.

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