RCS - Hutchmed China Ltd - Data to be Presented at the 2025 ESMO Congress

HUTCHMED (China)Announcement

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RNS Number : 0786D  Hutchmed (China) Limited  13 October 2025

Press Release

 

HUTCHMED Highlights FRUSICA-2 Registration Trial Data to be Presented at the 2025 ESMO Congress

 

- The fruquintinib and sintilimab combination demonstrated significant PFS
improvements in advanced renal cell carcinoma patients after progression on
first-line therapies -

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, October 13, 2025:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) announces results from the FRUSICA-2 registration
clinical trial of the fruquintinib and sintilimab combination for the
treatment of patients with locally advanced or metastatic renal cell
carcinoma. Results of the Phase III part of the study will be presented on
Friday, October 17, 2025 during the European Society for Medical Oncology
("ESMO") Congress in Berlin, Germany.

 

FRUSICA-2 is a randomized, open-label, active-controlled registration study
evaluating the efficacy and safety of fruquintinib in combination with
sintilimab versus axitinib or everolimus monotherapy for the second-line
treatment of advanced renal cell carcinoma (NCT05522231
(https://clinicaltrials.gov/study/NCT05522231) ). A total of 234 patients were
randomized into a group that received fruquintinib plus sintilimab combination
therapy, or into a group that received axitinib or everolimus monotherapy. As
of the progression free survival ("PFS") final analysis cutoff of February 17,
2025, the median follow-up was 16.6 months.

 

The median PFS as assessed by blinded independent central review (BICR) was
22.2 months with fruquintinib plus sintilimab, compared to 6.9 months with
axitinib/everolimus (stratified hazard ratio  HR  0.373; stratified log-rank
p<0.0001). The objective response rate (ORR) was 60.5% vs 24.3% (Odds Ratio
4.622, p<0.0001), and the median duration of response (DoR) was 23.7 vs
11.3 months, respectively. Overall survival data were still evolving at the
time of data cutoff with maturity of approximately 20%. Efficacy benefits were
observed in all prognostic risk groups, as defined by the International mRCC
Database Consortium (IMDC) criteria.

 

The safety profile of the fruquintinib and sintilimab combination was
tolerable and consistent with the known profiles of each individual treatment.
Treatment-emergent adverse events (TEAEs) of grade 3 or above occurred in
71.4% of patients in the fruquintinib plus sintilimab group compared to 58.8%
for patients in the axitinib/everolimus group.

 

"The FRUSICA-2 trial results provide compelling evidence that fruquintinib and
sintilimab may offer a valuable new treatment option for patients with
advanced renal cell carcinoma," said Professor Dingwei Ye of Fudan University
Shanghai Cancer Center and the co-leading Principal Investigator of the
FRUSICA-2 study. "These findings show the combination's potential to address a
critical unmet need for this patient population, delivering consistent
benefits across varied patient profiles and prognostic risk groups."

 

"The FRUSICA-2 study suggests that fruquintinib and sintilimab could play a
meaningful role in shaping second-line treatment strategies for advanced renal
cell carcinoma," said Professor Zhisong He of Peking University First
Hospital and the co-leading Principal Investigator of the FRUSICA-2 study.
"These results point to the combination's potential to enhance clinical
outcomes, providing a new option for managing this challenging disease."

 

Supported by data from FRUSICA-2, a New Drug Application (NDA) for the
combination of fruquintinib and sintilimab in patients with locally advanced
or metastatic renal cell carcinoma who have failed prior treatment has been
accepted for review by the China National Medical Products Administration
(NMPA).

 

About Kidney Cancer and Renal Cell Carcinoma

It is estimated that approximately 435,000 new patients were diagnosed with
kidney cancer worldwide in 2022.(( 1  (#_edn1) )) In China, an estimated
74,000 new patients were diagnosed with kidney cancer in 2022.(( 2  (#_edn2)
)) Approximately 90% of kidney tumors are renal cell carcinoma.

 

The safety and efficacy of fruquintinib for the investigational uses discussed
above 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

Fruquintinib is a selective oral inhibitor of all three vascular endothelial
growth factor receptors ("VEGFR") -1, -2 and -3. VEGFR inhibitors play a
pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to
limit off-target kinase activity and improve drug exposure to achieve
sustained target inhibition. 3  (#_edn3)

 

Fruquintinib is co-developed and co-commercialized in China by HUTCHMED and
Eli Lilly and Company under the brand name ELUNATE(®).  It is approved for
the treatment of patients with metastatic colorectal cancer who have
previously received fluoropyrimidine, oxaliplatin and irinotecan-based
chemotherapy, and those who have previously received or are not suitable to
receive anti-VEGF therapy or anti-epidermal growth factor receptor (EGFR)
therapy (RAS wild-type) in China. The combination of fruquintinib and
sintilimab has received conditional approval in China for the treatment of
patients with advanced pMMR endometrial cancer who have failed prior systemic
therapy and are not candidates for curative surgery or radiation.

 

Takeda holds the exclusive worldwide license to further develop,
commercialize, and manufacture fruquintinib outside mainland China, Hong Kong
and Macau, marketing it under the brand name FRUZAQLA(®).

 

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. Since inception it has
focused on bringing 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 approved around the world including in the US, Europe and Japan.
For more information, please visit: www.hutch‑med.com
(https://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 US Private Securities Litigation Reform
Act of 1995. These forward-looking statements reflect HUTCHMED's current
expectations regarding future events, including but not limited to its
expectations regarding the therapeutic potential of fruquintinib, the further
clinical development for fruquintinib, its expectations as to whether any
studies on fruquintinib would meet their primary or secondary endpoints, and
its expectations as to the timing of the completion and the release of results
from such studies. Such risks and uncertainties include, among other things,
assumptions regarding enrollment rates and the timing and availability of
subjects meeting a study's inclusion and exclusion criteria; changes to
clinical protocols or regulatory requirements; unexpected adverse events or
safety issues; the ability of fruquintinib, including as combination
therapies, to meet the primary or secondary endpoint of a study, to obtain
regulatory approval in different jurisdictions and to gain commercial
acceptance after obtaining regulatory approval; the potential markets of
fruquintinib for a targeted indication, and the sufficiency of funding. In
addition, as certain studies rely on the use of other drug products such as
sintilimab as combination therapeutics, such risks and uncertainties include
assumptions regarding their safety, efficacy, supply and continued regulatory
approval. 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 US Securities and Exchange Commission, The Stock Exchange of
Hong Kong Limited and on AIM. 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 / ir@hutch-med.com (mailto:ir@hutch-med.com)

 Media Enquiries
 FTI Consulting -                                    +44 20 3727 1030 / HUTCHMED@fticonsulting.com
                                                     (mailto:HUTCHMED@fticonsulting.com)
    Ben Atwell / Alex Shaw                              +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
 Brunswick - Zhou Yi                                 +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com
                                                     (mailto:HUTCHMED@brunswickgroup.com)

 Panmure Liberum                                     Nominated Advisor and Joint Broker
 Atholl Tweedie / Emma Earl / Rupert Dearden         +44 20 7886 2500

 Cavendish                                           Joint Broker
 Geoff Nash / Nigel Birks                            +44 20 7220 0500

 Deutsche Numis                                      Joint Broker
 Freddie Barnfield / Jeffrey Wong / Duncan Monteith  +44 20 7260 1000

 

 1  (#_ednref1)   The Global Cancer Observatory, kidney cancer fact sheet.
https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/cancers/29-kidney-fact-sheet.pdf)
. Accessed February 19, 2025.

 2  (#_ednref2)   The Global Cancer Observatory, China fact sheet.
https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf
(https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf)
. Accessed February 19, 2025.

 3  (#_ednref3)   Sun Q, et al. Discovery of fruquintinib, a potent and
highly selective small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases
for cancer therapy. Cancer Biol Ther. 2014;15(12):1635-45. doi:
10.4161/15384047.2014.964087.

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