RCS - Hutchmed China Ltd - HUTCHMED and Innovent Announce NDA Acceptance

HUTCHMED (China)Announcement

02/04/2024 07:15

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RNS Number : 8974I  Hutchmed (China) Limited  02 April 2024

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 (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) and Innovent Biologics, Inc. ("Innovent
(https://www.innoventbio.com/) ") (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
(https://www.clinicaltrials.gov/study/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
(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, 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
(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 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
(https://www.hutch-med.com/) or follow us on LinkedIn
(https://www.linkedin.com/company/hutchmed/) .

 

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                                                  +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    pMMR = Mismatch Repair proficient.

 2    MSI-H = Microsatellite instability-high.

 3    The Global Cancer Observatory (https://gco.iarc.fr/) , World Fact
Sheet
(https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf)
. Accessed June 12, 2023.

 4    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 June 12, 2023.

 5    Yi A, et al. Real-world characteristics and treatment pattern of
patients with newly diagnosed endometrial cancer in China.  J Clin Oncol.
2023;41, no. 16_suppl (June 01, 2023) e17613-e17613. DOI:
10.1200/JCO.2023.41.16_suppl.e17613.

 6    Koppikar S, et al. Pan-Asian adapted ESMO Clinical Practice Guidelines
for the diagnosis, treatment and follow-up of patients with endometrial
cancer. ESMO Open. 2023;8(1):100774. DOI: 10.1016/j.esmoop.2022.100774.

 7    Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin.
2023;73(1):17-48. DOI:10.3322/caac.21763.

 8    Wang J, et al. Durable blockade of PD-1 signaling links preclinical
efficacy of sintilimab to its clinical benefit. mAbs 2019;11(8): 1443-1451.
DOI: 10.1080/19420862.2019.1654303.

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