RCS - Hutchmed China Ltd - Presentation of Phase III Data on Fruquintinib

HUTCHMED (China)Announcement

07/02/2024 07:00

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RNS Number : 2475C  Hutchmed (China) Limited  07 February 2024

Press Release

 

HUTCHMED Highlights Presentation of Phase III Data on Fruquintinib in Second-Line Gastric Cancer at ASCO Plenary Series Session

 

Hong Kong, Shanghai & Florham Park, NJ - Wednesday, February 7, 2024:
HUTCHMED (China) Limited ("HUTCHMED (https://www.hutch-med.com/) ")
(Nasdaq/AIM:HCM; HKEX:13) today announces that data 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 presented at
the American Society of Clinical Oncology ("ASCO") Plenary Series Session on
February 6, 2024. The full presentation can be found here
(https://www.asco.org/meetings-education/monthly-plenary-series/program) .
Fruquintinib is a selective oral inhibitor of vascular endothelial growth
factor receptors ("VEGFR") -1, -2 and -3, which play a pivotal role in
blocking tumor angiogenesis.

 

The ASCO Plenary Series was established to feature practice-changing and
clinically relevant studies on the latest advances in cancer care. 1 

 

The FRUTIGA trial (clinicaltrials.gov identifier NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) ) was a 1:1 randomized,
double-blind, Phase III study conducted at 35 sites in China to evaluate
fruquintinib combined with chemotherapy, paclitaxel, compared with paclitaxel
monotherapy for second-line treatment of 703 patients with advanced gastric or
gastroesophageal junction adenocarcinoma. The dual primary endpoints were
progression-free survival ("PFS") and overall survival ("OS"), and the study
was declared positive as the PFS endpoint met statistical significance at a
pre-defined alpha level.

 

Median PFS for patients who received fruquintinib plus paclitaxel was 5.6
months, compared to 2.7 months for those who received paclitaxel monotherapy,
a statistically significant improvement (stratified hazard ratio  "HR"  =
0.569; p < 0.0001). The objective response rate ("ORR") was significantly
higher in the fruquintinib combination group (42.5% vs. 22.4%).

 

There was an improvement in OS with median OS of 9.6 months vs. 8.4 months,
however this was not statistically significant. There was an imbalance of
patients receiving subsequent antitumor therapies across the two groups, with
52.7% in the fruquintinib plus paclitaxel group vs. 72.2% in the paclitaxel
monotherapy group. Pre-specified sensitivity analyses showed that in patients
without these subsequent antitumor therapies, OS improvement was statistically
significant. Median OS for patients who received the combination therapy was
6.9 months compared to 4.8 months for those receiving the placebo, with a HR
of 0.72 (p = 0.0422).

 

Fruquintinib demonstrated a statistically significant improvement in multiple
other endpoints, including disease control rate ("DCR") at 77.2% vs. 56.3%,
and duration of response ("DoR") at 5.5 vs. 3.7 months. The most common (at
least 5%) grade 3 or above treatment-emergent adverse events were neutropenia
(60.0% vs. 36.4%), leukopenia (42.9% vs. 23.5%), anemia (11.7% vs. 10.6%) and
palmar-plantar erythrodysesthesia syndrome (8.9% vs. 4.9%). As such,
fruquintinib plus paclitaxel was well-tolerated with a safety profile
consistent with expectations.

 

The presentation concludes that fruquintinib plus paclitaxel could be a
promising second-line treatment option for patients with advanced gastric or
gastro-esophageal adenocarcinoma who have failed fluoropyrimidine- or
platinum-containing chemotherapy.

 

 Presentation title                                                              Presenter & Lead author      Presentation details
 Fruquintinib plus paclitaxel versus paclitaxel as second-line therapy for       Rui-Hua Xu,                  February ASCO Plenary Series Session
 patients with advanced gastric or gastroesophageal junction adenocarcinoma
                            (https://www.asco.org/meetings-education/monthly-plenary-series/program)
 (FRUTIGA): a randomized, multicenter, double-blind, placebo-controlled, phase   MD, PhD

 3 study                                                                                                      Abstract 438730

                                                                                                              Tuesday, February 6, 2024

                                                                                                              3 pm ET (8pm GMT, 4am HKT)

 

The 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 in April 2023.
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 ("mCRC").

 

 

About the ASCO Plenary Series

According to ASCO, the ASCO Plenary Series was established to feature
practice-changing and clinically relevant studies on the latest advances in
cancer care. Up to two abstracts are presented in each session, and
accompanied by a discussant presentation and a live question and answer
session. It was developed by ASCO so that researchers and clinicians can stay
current on cutting-edge research in oncology in between meetings, providing
faster dissemination of practice-changing science to better help clinicians
deliver the most up-to-date care and treatments to patients.

 

Abstracts at the ASCO Plenary Series are expected to address novel scientific
questions, detail clinical observations, and contain primary scientific data
in the form of a randomized phase II and III trial, or be original research
studies that highlight novel and high-impact research with practice-changing
implications. Presented studies are also expected to be placed in an oral
presentation at the ASCO Annual Meeting.

 

About the Phase III FRUTIGA Trial

FRUTIGA is a randomized, double-blind, Phase III study in China to evaluate
fruquintinib combined with paclitaxel compared with paclitaxel monotherapy,
for second-line treatment of advanced gastric cancer. The study enrolled 703
patients. Its dual-primary endpoints were PFS and OS. The trial met the PFS
endpoint at a statistically and clinically meaningful level. While there was
an improvement in median OS, the OS endpoint was not statistically significant
per the pre-specified statistical plan. Fruquintinib also demonstrated a
statistically significant improvement in secondary endpoints including
objective response rate (ORR), DCR and DoR. The safety profile of fruquintinib
in FRUTIGA was consistent with previously reported studies. Additional details
may be found at clinicaltrials.gov, using identifier NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) .

 

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. 2  In China, it was estimated that over 478,000
people were diagnosed with gastric cancer, and approximately 374,000 people
died from gastric cancer. 3 

 

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 the 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

Fruquintinib is approved for marketing in China, where it is co-marketed by
HUTCHMED and Lilly 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 mCRC 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,
fruquintinib has benefited more than 80,000 colorectal cancer patients as of
mid-2023.

 

About Fruquintinib Approval in the United States

Fruquintinib received approval in the United States in November 2023, where it
is marketed by Takeda under the brand name FRUZAQLA™. The approval was based
on data from two large 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. The trials
investigated fruquintinib plus best supportive care versus placebo plus best
supportive care in patients with previously treated mCRC. Both FRESCO and
FRESCO-2 met their primary and key secondary efficacy endpoints and showed
consistent benefit among a total of 734 patients treated with fruquintinib.
Safety profiles were consistent across trials.

 

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, the timing of these events, and the impact of the COVID-19
pandemic on general economic, regulatory and political conditions. 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  Plenary Series FAQs | ASCO
(https://old-prod.asco.org/meetings-education/asco-plenary-series/plenary-series-faqs)
.  Accessed January 31, 2024.

 2  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.

 3  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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