Press Release
HUTCHMED and Innovent Jointly Announce NDA
Acceptance in China for Fruquintinib Combination with Sintilimab
for the Treatment of Advanced Endometrial Cancer with Priority
Review Status
- NDA accepted and both fruquintinib and sintilimab
granted Priority Review, following Breakthrough Therapy designation
in July 2023 -
- First regulatory filing for fruquintinib for use in
combination with a leading immune checkpoint inhibitor -
Hong Kong, Shanghai
& Florham Park, NJ - Tuesday, April 2, 2024: HUTCHMED
(China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) and Innovent Biologics, Inc. ("Innovent") (HKEX:1801) today
jointly announce that the New Drug Application ("NDA") for the
combination of fruquintinib and sintilimab for the treatment of
patients with advanced endometrial cancer with pMMR[1] or non-MSI-H[2] tumors that
have failed prior systemic therapy but are not candidates for
curative surgery or radiation has been accepted and granted
priority review by the China National Medical Products
Administration ("NMPA").
The NDA is supported by data from FRUSICA-1, the
endometrial cancer registration cohort of a multi-center,
open-label Phase II study investigating fruquintinib in combination
with sintilimab in endometrial cancer patients who experienced
disease recurrence, disease progression or intolerable toxicity
with treatment on platinum-based doublet chemotherapy. The primary
endpoint was independent review committee (IRC) assessed objective
response rate (ORR), with secondary endpoints including disease
control rate (DCR), duration of response (DoR), progression free
survival (PFS), overall survival (OS), as well as pharmacokinetic
(PK) assessments. Data from FRUSICA-1 will be submitted for
presentation at an upcoming medical conference. Additional details
may be found at clinicaltrials.gov, using identifier NCT03903705.
"This is the first regulatory filing for the
combination of fruquintinib and the immune checkpoint inhibitor
sintilimab. It also represents an important step closer to
reshaping the treatment landscape for this challenging disease in
China," said Dr.
Michael Shi, Head of R&D and Chief Medical Officer of
HUTCHMED. "Endometrial cancer remains one of the most
common gynecological malignancies. We look forward to bringing this
much-awaited treatment advancement to endometrial cancer patients
to improve their treatment outcome."
"TYVYT® (sintilimab injection), as a
backbone therapy in immuno-oncology, in combination with an
anti-angiogenetic drug, may improve the prognosis for endometrial
cancer patients in China," said Dr. Hui Zhou, Senior Vice
President of Innovent. "We are excited about the NDA
acceptance and priority review designation, which increases our
potential to bring a new treatment option to endometrial cancer
patients, and concurrently strengthens the leadership position of
TYVYT® in China."
The NMPA granted Breakthrough Therapy designation to
the combination of fruquintinib and sintilimab for this potential
indication in July 2023. The NMPA granted this designation to this
combination as a new treatment that could target a serious
condition for which there are no effective treatment options, and
where clinical evidence demonstrates substantial advantages over
existing therapies.
About Endometrial Cancer
Endometrial cancer is a type of cancer that begins in
the uterus. Globally, an estimated 417,000 people were diagnosed
with endometrial cancer and it caused approximately 97,000 deaths
in 2020.[3] Іn China, an estimated 82,000
people were diagnosed with endometrial cancer, causing
approximately 17,000 deaths in 2020.[4]
Although early-stage endometrial cancer can be surgically resected,
recurrent and/or metastatic endometrial cancer remains an area of
high unmet need with poor outcomes and limited treatment
options.[5],[6],[7]
About Fruquintinib
Fruquintinib is a selective oral inhibitor of
vascular endothelial growth factor receptor ("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 a 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 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 for receiving anti-vascular
endothelial growth factor ("VEGF") therapy or anti-epidermal growth
factor receptor ("EGFR") therapy (RAS wild-type) in China, where it
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 colorectal cancer in China, which were published
in The Journal of the American Medical Association, JAMA. Since its launch in China and as
of mid-2023, fruquintinib has benefited more than 80,000 colorectal
cancer patients.
About Fruquintinib Approval in the United
States
Fruquintinib received approval for the treatment of
adult patients with metastatic colorectal cancer who have been
previously treated with fluoropyrimidine, oxaliplatin, and
irinotecan‑based chemotherapy, an
anti‑VEGF therapy, and, if RAS
wild‑type and medically appropriate, an
anti-EGFR therapy 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 metastatic colorectal cancer. 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. Takeda
has the exclusive worldwide license to further develop,
commercialize, and manufacture fruquintinib outside of mainland
China, Hong Kong and Macau.
About Sintilimab
Sintilimab, marketed as TYVYT® (sintilimab
injection) in China, is a PD-1 immunoglobulin G4 monoclonal
antibody co-developed by Innovent and Eli Lilly and Company.
Sintilimab is a type of immunoglobulin G4 monoclonal antibody,
which binds to PD-1 molecules on the surface of T-cells, blocks the
PD-1 / PD-Ligand 1 (PD-L1) pathway, and reactivates T-cells to kill
cancer cells.[8]
In China, sintilimab has been approved and included
in the NRDL for seven indications. The updated NRDL reimbursement
scope for TYVYT® (sintilimab injection) includes:
· For the treatment of relapsed
or refractory classic Hodgkin's lymphoma after two lines or later
of systemic chemotherapy;
· For the first-line treatment
of unresectable locally advanced or metastatic non-squamous
non-small cell lung cancer lacking EGFR or ALK driver gene
mutations;
· For the treatment of patients
with EGFR-mutated locally advanced or metastatic non-squamous
non-small cell lung cancer who progressed after EGFR-TKI
therapy;
· For the first-line treatment
of unresectable locally advanced or metastatic squamous non-small
cell lung cancer;
· For the first-line treatment
of unresectable or metastatic hepatocellular carcinoma with no
prior systematic treatment;
· For the first-line treatment
of unresectable locally advanced, recurrent or metastatic
esophageal squamous cell carcinoma;
· For the first-line treatment
of unresectable locally advanced, recurrent or metastatic gastric
or gastroesophageal junction adenocarcinoma.
Besides, the combination of sintilimab and
fruquintinib for the treatment of patients with advanced
endometrial cancer with pMMR or non-MSI-H tumors that have failed
prior systemic therapy but are not candidates for curative surgery
or radiation has been accepted and granted priority review by the
NMPA.
In addition, two clinical studies of sintilimab have
met their primary endpoints:
· Phase II study of sintilimab
monotherapy as second-line treatment of esophageal squamous cell
carcinoma;
· Phase III study of sintilimab
monotherapy as second-line treatment for squamous NSCLC with
disease progression following platinum-based
chemotherapy.
Statement: Innovent
does not recommend the use of any unapproved
drug(s)/indication(s).
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.
About Innovent
Innovent is a leading biopharmaceutical company
founded in 2011 with the mission to provide high-quality biologics
that are affordable to all. The company discovers, develops,
manufactures and commercializes innovative medicines that treat
some of the most intractable diseases. Its pioneering therapies
treat cancer, cardiovascular and metabolic, autoimmune and eye
diseases. Innovent has launched 10 products in the market, 3 new
drug applications under NMPA review, 5 assets in Phase III or
pivotal clinical trials and 18 more molecules in early clinical
stage. Innovent partners with over 30 global healthcare leaders,
including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson
Cancer Center.
Guided by the motto, "Start with Integrity, Succeed
through Action," Innovent maintains the highest standard of
industry practices and works collaboratively to advance the
biopharmaceutical industry so that first-rate pharmaceutical drugs
can become widely accessible. For more information, visit
www.innoventbio.com, or follow Innovent on Facebook and
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 the fruquintinib and sintilimab
combination for the treatment of patients with advanced endometrial
cancer and the further clinical development of the fruquintinib and
sintilimab combination 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 the fruquintinib and sintilimab combination for the treatment of
patients with advanced endometrial cancer in China, 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 the
fruquintinib and sintilimab combination, and the timing of these
events. 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. 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
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+852 2121 8200 /
ir@hutch-med.com
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Media Enquiries
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Ben Atwell / Alex Shaw,
FTI Consulting
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+44 20 3727 1030 /
+44 7771 913 902 (Mobile) /
+44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.com
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Zhou Yi, Brunswick
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+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
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+44 (20) 7886 2500
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