RCS - Hutchmed China Ltd - HUTCHMED and Innovent Announce ELUNATE Approval

HUTCHMED (China)Announcement

03/12/2024 10:00

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RNS Number : 5948O  Hutchmed (China) Limited  03 December 2024

Press Release

 

HUTCHMED and Innovent Jointly Announce NMPA Conditional Approval for
ELUNATE(®) (Fruquintinib) in Combination with TYVYT(®) (Sintilimab
Injection) for the Treatment of Advanced Endometrial Cancer

 

- First regulatory approval for fruquintinib combination therapy with an
immune checkpoint inhibitor -

 

Hong Kong, Shanghai & Florham Park, NJ - Tuesday, December 3, 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 ELUNATE(®) (fruquintinib)
and TYVYT(®) (sintilimab injection) has been granted conditional approval in
China for the treatment of patients with advanced endometrial cancer with
Mismatch Repair proficient ("pMMR") tumors that have failed prior systemic
therapy and are not candidates for curative surgery or radiation.  This
approval follows the priority review status and breakthrough therapy
designation by the National Medical Products Administration ("NMPA") of China
and marks the first regulatory approval for the combination of fruquintinib
with a leading immune checkpoint inhibitor.

 

The conditional approval by the NMPA was supported by registration stage 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 have experienced disease
recurrence, disease progression or intolerable toxicity with treatment on
platinum-based doublet chemotherapy. Results from FRUSICA-1 were presented at
the American Society of Clinical Oncology annual meeting in June 2024. 1 
(#_edn1) The study results showed that IRC-assessed objective response rate
(ORR) and disease control rate (DCR) was 35.6% and 88.5% respectively. The
combination treatment showed rapid on-set efficacy, with a median time to
response (TTR) of only 1.6 months. The median progression free survival (PFS)
and overall survival (OS) reached 9.5 months and 21.3 months respectively.
Adverse events are consistent with those reported for similar immunotherapy
and antiangiogenic agents combination treatments. Additional details can be
found at clinicaltrials.gov, using identifier NCT03903705
(https://www.clinicaltrials.gov/study/NCT03903705) .

 

"This approval of fruquintinib plus sintilimab could represent a paradigm
shift in managing this challenging disease. This innovative combination not
only leverages the synergistic effects of targeted therapy and immunotherapy,
but also addresses a critical gap in treatments available for patients with
limited responses to traditional therapies," said Prof. Xiaohua Wu, Director
of the Department of Gynecologic Oncology at Fudan University Affiliated
Cancer Hospital and Principal Investigator of the FRUSICA-1 study. "With the
promising efficacy and manageable safety profile observed in clinical trials,
we are eager to have this treatment option available to patients. It brings us
closer to our goal of improving survival and enhancing quality of life for
patients living with advanced endometrial cancer."

 

"This NMPA approval of fruquintinib in combination with sintilimab represents
a significant advancement for patients with advanced endometrial cancer who
have long await more effective treatments. It underscores the potential of
fruquintinib to be used with other therapeutic agents to improve patient
outcomes," said Dr. Michael Shi, Head of R&D and Chief Medical Officer of
HUTCHMED. "It is also a testament to our ongoing efforts to extend the
clinical benefit of fruquintinib to a broader patient population. We are eager
to make this innovative treatment available to advanced endometrial cancer
patients as soon as we can and will continue to explore further opportunities
to bring hope to more patients battling cancer."

 

Dr. Hui Zhou, Senior Vice President of Innovent, stated: "This approval of
sintilimab and fruquintinib combination therapy marks a meaningful advancement
in the treatment landscape for advanced endometrial cancer. Together with
HUTCHMED, we aim to provide a novel treatment option that improves survival
rates and quality of life for patients facing limited treatment options
against this aggressive cancer. TYVYT(®) (sintilimab injection), as a
cornerstone in immuno-therapy, continues to be evaluated in clinical trials in
combination with novel modalities. We remain steadfast in our commitment to
reinforcing the leadership position of TYVYT(®) (sintilimab injection) in
immuno-therapy and driving forward treatment solutions through innovation and
cooperation."

 

In July 2023, the NMPA granted Breakthrough Therapy Designation to the
combination of fruquintinib and sintilimab for this potential indication. This
designation recognizes the potential of a therapy to address a severe
condition with no effective treatment options, and where clinical evidence
demonstrates substantial advantages over existing therapies.

 

A Phase III confirmatory study of the fruquintinib and sintilimab combination
in this setting has been planned (NCT06584032
(https://clinicaltrials.gov/study/NCT06584032) ).

 

About Endometrial Cancer

 

Endometrial cancer originates in the uterus and remains a significant global
health challenge. In 2020, approximately 417,000 people were diagnosed with
endometrial cancer, resulting in around 97,000 deaths. 2  (#_edn2) Іn China
alone, an estimated 82,000 new cases and 17,000 were reported in 2020. 3 
(#_edn3) While early-stage endometrial cancer can often be surgically
resected, recurrent and/or metastatic endometrial cancer remains an area of
high unmet need with poor outcomes and limited treatment options. 4  (#_edn4)
(, 5  (#_edn5) , 6  (#_edn6) )

 

About Fruquintinib

 

Fruquintinib is a selective oral inhibitor of all three vascular endothelial
growth factor ("VEGF") receptors (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
drug exposure that achieves sustained target inhibition and flexibility for
potential use as part of a combination therapy.

 

About Fruquintinib Approvals

 

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-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. Since its launch in China, over 100,000
patients with colorectal cancer have been treated with fruquintinib.

 

Takeda has the exclusive worldwide license to further develop, commercialize,
and manufacture fruquintinib outside of mainland China, Hong Kong and Macau,
and markets under the FRUZAQLA(®) brand name.  Fruquintinib received
approval in the US
(https://www.hutch-med.com/us-fda-approval-of-fruzaqla-fruquintinib/) in
November 2023, in the EU
(https://www.hutch-med.com/european-commission-approval-for-fruzaqla-fruquintinib/)
in June 2024, in Switzerland in August 2024, in Canada, Japan
(https://www.hutch-med.com/japan-approval-for-fruzaqla-fruquintinib/) and the
United Kingdom in September 2024 and in Argentina, Australia and Singapore in
October 2024. Regulatory applications are progressing in many other
jurisdictions.

 

The global regulatory submissions are based on data from two large,
randomized, controlled Phase III trials, the global, multi-regional FRESCO-2
trial and the FRESCO trial conducted in China, showing consistent benefit
among a total of 734 patients treated with fruquintinib. Safety profiles were
consistent across trials. Results from the FRESCO-2 trial were published
(https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)00772-9/fulltext)
in The Lancet in June 2023, 7  (#_edn7) while results from the FRESCO trial
were published (https://jamanetwork.com/journals/jama/fullarticle/2685988) in
The Journal of the American Medical Association, JAMA. 8  (#_edn8)

 

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. 9 
(#_edn9)

 

In China, sintilimab has been approved and included in the updated 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.

 

Furthermore, sintilimab's eighth indication, in combination with fruquintinib
for the treatment of patients with advanced endometrial cancer with pMMR
tumors that have failed prior systemic therapy and are not candidates for
curative surgery or radiation, has been approved by the NMPA in December 2024.

 

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 non-small cell lung cancer 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
approved in the US, Europe and Japan. 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 empower patients worldwide with affordable, high-quality
biopharmaceuticals. The company discovers, develops, manufactures and
commercializes innovative medicines that target some of the most intractable
diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic,
autoimmune and eye diseases. Innovent has launched 11 products in the market.
It has 5 new drug applications under regulatory review, 3 assets in Phase III
or pivotal clinical trials and 17 more molecules in early clinical stage.
Innovent partners with over 30 global healthcare companies, including Eli
Lilly, Sanofi, Incyte, Adimab, LG Chem 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 and other jurisdictions, the safety
profile of the fruquintinib and sintilimab combination, 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
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, The Stock Exchange of Hong Kong Limited and on AIM.
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 Liberum     +44 (20) 7886 2500

 

 1  (#_ednref1)     Wu X, et al. Fruquintinib plus sintilimab in treated
advanced endometrial cancer (EMC) patients (pts) with PMMR status: Results
from a multicenter, single-arm phase 2 study. J Clin Oncol 42, 2024 (suppl
16; abstr 5619). DOI: 10.1200/JCO.2024.42.16_suppl.5619.

 2  (#_ednref2)      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.

 3  (#_ednref3)      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.

 4  (#_ednref4)      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.

 5  (#_ednref5)      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.

 6  (#_ednref6)      Siegel RL, et al. Cancer statistics, 2023. CA Cancer
J Clin. 2023;73(1):17-48. DOI:10.3322/caac.21763.

 7  (#_ednref7)      Dasari NA, et al. Fruquintinib versus placebo in
patients with refractory metastatic colorectal cancer (FRESCO‑2): an
international, multicentre, randomised, double‑blind, Phase III study.
Lancet. 2023;402(10395):41‑53. doi:10.1016/S0140‑6736(23)00772‑9.

 8  (#_ednref8)      Li J, et al. Effect of Fruquintinib vs Placebo on
Overall Survival in Patients With Previously Treated Metastatic Colorectal
Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496.
DOI:10.1001/jama.2018.7855.

 9  (#_ednref9)      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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