RCS - Hutchmed China Ltd - Nature Medicine Publish Phase III FRUTIGA Results

HUTCHMED (China)Announcement

03/06/2024 07:00

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RNS Number : 7449Q  Hutchmed (China) Limited  03 June 2024

Press Release

 

HUTCHMED Highlights Publication of Phase III FRUTIGA Results in Nature Medicine

 

Updated subgroup efficacy and quality of life data were also presented on June
1 at ASCO 2024

 

Hong Kong, Shanghai & Florham Park, NJ - Monday, June 3, 2024: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM: HCM;
HKEX: 13) today announces that results from FRUTIGA, HUTCHMED's Phase III
trial of fruquintinib in combination with paclitaxel for the treatment of
second-line advanced gastric cancer in China, were published
(https://www.nature.com/articles/s41591-024-02989-6) in Nature Medicine.
Updated efficacy data in key subgroups and data on quality of life (QoL)
within this publication were also presented on June 1 at the American Society
of Clinical Oncology ("ASCO") 2024 Annual Meeting.

 

Fruquintinib is a selective oral inhibitor of vascular endothelial growth
factor receptors ("VEGFRs") 1, 2 and 3. It works as an anti-cancer therapy by
blocking tumor angiogenesis, a proliferation of blood vessels that is critical
for cancer growth. The VEGFR pathway plays a key role in the pathogenesis of
gastric cancer, which is the fifth most common malignant cancer worldwide,
with 1.1 million new cases per year 1 . The FRUTIGA trial results published by
Nature Medicine suggest that fruquintinib could be another effective treatment
option for gastric cancer patients.

 

FRUTIGA was a 1:1 randomized, double-blind, Phase III study conducted across
35 sites in China (NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) ). It evaluated fruquintinib
in combination with paclitaxel chemotherapy, compared with paclitaxel
monotherapy, for second-line treatment in 703 patients with advanced gastric
or gastroesophageal junction adenocarcinoma. The study was declared positive
due to a statistically significant improvement in progression-free survival
("PFS"), one of two dual primary endpoints. Median PFS for patients who
received fruquintinib plus paclitaxel was 5.6 months, compared to 2.7 months
for those who received paclitaxel monotherapy (stratified hazard ratio  "HR" 
= 0.569; p < 0.0001). An improvement was also observed in the dual primary
endpoint of median overall survival ("OS"), (9.6 months vs. 8.4 months) but
this was not statistically significant. Fruquintinib plus paclitaxel
demonstrated statistically significant improvements in multiple other
endpoints including objective response rate ("ORR"), disease control rate
(DCR) and duration of response (DoR). It was well tolerated, with a safety
profile consistent with expectations and previously reported studies. 2 

 

In further analysis of key subgroups presented at ASCO, PFS and OS results
were consistent with the primary analysis compared to the intention-to-treat
(ITT) population. There was a clear PFS benefit observed for fruquintinib plus
paclitaxel in the majority of subgroups, with particular benefit in both PFS
and OS in the intestinal-type and lymph node metastasis subgroups. An
exploratory post-hoc analysis for patients with lymph node metastasis revealed
superior benefits of fruquintinib versus placebo in PFS, OS, ORR, disease
control rate and duration of response. A possible mechanism for this effect is
fruquintinib's potent inhibition of VEGFR-‑3, which is closely linked to
lymph node metastasis and tumor invasion. Further analysis of patient-reported
quality of life ("QoL") revealed no adverse impact on QoL at end of treatment
compared to current standard of care. Together, these additional findings,
alongside previously reported results, support fruquintinib plus paclitaxel as
another treatment option in this indication.

 

Key results from FRUTIGA were previously disclosed
(https://www.hutch-med.com/frutiga-phase-iii-data-on-fruquintinib-in-second-line-gastric-cancer-at-asco-plenary-series-session/)
at the American Society of Clinical Oncology (ASCO) Plenary Series Session on
February 6, 2024, with the full presentation available here
(https://www.asco.org/meetings-education/monthly-plenary-series/program) . 3 

 

Fruquintinib is approved in China and the United States
(https://www.hutch-med.com/us-fda-approval-of-fruzaqla-fruquintinib/) for the
treatment of certain patients with metastatic colorectal cancer ("CRC"). A New
Drug Application ("NDA") for fruquintinib in combination with paclitaxel for
the treatment of second-line advanced gastric or gastroesophageal junction
adenocarcinoma in China was accepted for review
(https://www.hutch-med.com/nda-acceptance-in-china-for-fruquintinib-in-2l-gastric-cancer/)
by the China National Medical Products Administration (NMPA) in April 2023.

 

About Gastric Cancer

 

Gastric cancer is a cancer that starts in the stomach. It is the fifth most
common cancer worldwide in 2020. It was estimated to have caused approximately
770,000 deaths worldwide. 4  In China, it was estimated that over 478,000
people were diagnosed with gastric cancer, and approximately 374,000 people
died from gastric cancer. 5 

 

About Fruquintinib

 

Fruquintinib is a selective oral inhibitor of VEGFR-1, -2 and -3. VEGFR
inhibitors play a pivotal role in inhibiting 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 its potential use as part of combination therapy. Fruquintinib
has demonstrated a manageable safety profile and is being investigated in
combinations with other anti-cancer therapies.

 

About Fruquintinib Approval in China

 

In China, fruquintinib is co-developed and co-marketed by HUTCHMED and Eli
Lilly and Company under the brand name ELUNATE(®). It was included in the
China National Reimbursement Drug List (NRDL) in January 2020. The approval
was based on data from the FRESCO study, a Phase III pivotal registration
trial of fruquintinib in 416 patients with metastatic CRC in China, which were
published (https://jamanetwork.com/journals/jama/fullarticle/2685988) in the
Journal of the American Medical Association, JAMA. Since its launch in China
and as of mid‑2023, more than 80,000 colorectal cancer patients have been
treated with fruquintinib.

 

About Fruquintinib Approval in the U.S.

 

Takeda has the exclusive worldwide license to further develop, commercialize,
and manufacture fruquintinib outside of mainland China, Hong Kong and Macau.
Fruquintinib received approval in the U.S.
(https://www.hutch-med.com/us-fda-approval-of-fruzaqla-fruquintinib/) in
November 2023, where it is marketed by Takeda under the brand name
FRUZAQLA(®). The approval was based on data from two large, randomized,
controlled Phase III trials: the multi-regional FRESCO-2 trial, data from
which were published
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext)
in The Lancet, along with the FRESCO trial conducted in China, showing
consistent benefit among a total of 734 patients treated with fruquintinib.
Safety profiles were consistent across trials. Please see FRUZAQLA(®) full
Prescribing Information here
(https://takeda.info/Fruzaqla-Prescribing-Information) .

 

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
(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 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 gastric cancer 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 NDA approval
of fruquintinib for the treatment of patients with advanced gastric cancer in
China, 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, and the timing of these events. 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.

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
 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

 

 

 1  World Health Organization. GLOBOCAN 2020. Population fact sheets. China,
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)
(2020).

 2  Wang F, et al. Fruquintinib plus paclitaxel versus placebo plus paclitaxel
as second-line therapy for advanced gastric or gastro-esophageal junction
adenocarcinoma (FRUTIGA): a randomized, multicenter, double-blind,
placebo-controlled, phase 3 study [published online ahead of print, 2024 Jun
1]. Nat Med. 2024. DOI: 10.1038/s41591-024-02989-6.

 3  Xu RH, et al., Fruquintinib plus paclitaxel versus paclitaxel as
second-line therapy for patients with advanced gastric or gastroesophageal
junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind,
placebo-controlled, phase 3 study. J Clin Oncol. 2024;42, 438780-438780. DOI:
10.1200/JCO.2024.42.36_suppl.438780.

 4  The Global Cancer Observatory (https://gco.iarc.fr/) , Stomach Cancer Fact
Sheet
(https://gco.iarc.fr/today/data/factsheets/cancers/7-Stomach-fact-sheet.pdf)
.  Accessed April 6, 2023.

 5  The Global Cancer Observatory (https://gco.iarc.fr/) , China Fact Sheet
(https://gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf)
. Accessed April 6, 2023.

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