HUTCHMED (China) Limited (“HUTCHMED”) (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. 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) 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 gastroesophageal
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 patients with advanced gastric or
gastroesophageal junction adenocarcinoma (FRUTIGA): a randomized,
multicenter, double-blind, placebo-controlled, phase 3
study |
Rui-Hua Xu, MD, PhD |
February ASCO Plenary Series SessionAbstract 438730Tuesday,
February 6, 20243 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 by the China
National Medical Products Administration in April 2023.
Fruquintinib is approved in China and the United States 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.
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 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 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 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
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 |
|
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Media Enquiries |
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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 |
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|
Nominated Advisor |
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Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
1 Plenary Series FAQs | ASCO. Accessed January
31, 2024.2 The Global Cancer Observatory, Stomach Cancer Fact
Sheet. Accessed April 6, 2023. 3 The Global Cancer Observatory,
China Fact Sheet. Accessed April 6, 2023.
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