RCS - Hutchmed China Ltd - Breakthrough Therapy Designation for Fruquintinib

HUTCHMED (China)Announcement

20/07/2023 07:00

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RNS Number : 5221G  Hutchmed (China) Limited  20 July 2023

Press Release

 

HUTCHMED Receives Breakthrough Therapy Designation in China for Fruquintinib Combination with Sintilimab for Treatment of Advanced Endometrial Cancer, and Completes Enrollment of Registration Study

 

Hong Kong, Shanghai & Florham Park, NJ - Thursday, July 20, 2023: HUTCHMED
(China) Limited ("HUTCHMED (https://www.hutch-med.com/) ") (Nasdaq/AIM:HCM;
HKEX:13) today announces that the Center for Drug Evaluation of China's
National Medical Products Administration ("NMPA") has granted Breakthrough
Therapy Designation ("BTD") to the combination of fruquintinib and sintilimab
(a PD-1 antibody) for the treatment of patients with advanced endometrial
cancer ("EMC") with pMMR 1  tumors that have failed at least one line of
platinum-based therapy. A study for potential registration of this combination
in patients with previously treated advanced EMC in China has recently
completed enrollment.

 

It is a multi-center, open-label clinical study to evaluate the efficacy and
safety of fruquintinib in combination with sintilimab. Entry criteria include
those EMC patients who experienced disease recurrence, disease progression or
grade 3 or higher serious adverse events with treatment on platinum-based
chemotherapy. The primary endpoint is independent review committee (IRC)
assessed objective response rate ("ORR"), with secondary endpoints including
disease control rate ("DCR"), progression free survival ("PFS"), overall
survival ("OS"), as well as pharmacokinetic (PK) assessments. A total of 142
previously treated, advanced EMC patients were enrolled. Additional details
may be found at clinicaltrials.gov, using identifier NCT03903705
(https://www.clinicaltrials.gov/ct2/show/NCT03903705) .

 

Favorable results from this trial could lead to submission to the NMPA in the
first half of 2024 for regulatory approval in this treatment setting.

 

About Breakthrough Therapy Designation in China

NMPA grants BTD to new drugs that treat life-threatening diseases or serious
conditions for which there are no effective treatment options, and where
clinical evidence demonstrates significant advantages over existing therapies.
Drug candidates with BTD may be considered for conditional approval and
priority review when submitting a New Drug Application ("NDA"). This indicates
that the development and review of the therapy for this disease indication may
be expedited, to address patients' unmet needs more quickly.

 

About EMC

EMC is a type of cancer that begins in the uterus. Globally, an estimated
417,000 people were diagnosed with EMC and it caused approximately 97,000
deaths in 2020. 2  Іn China, an estimated 82,000 people were diagnosed with
EMC and it caused approximately 17,000 deaths in 2020. 3  Although early-stage
EMC can be surgically resected, recurrent and/or metastatic EMC remains an
area of high unmet need with poor outcomes and limited treatment
options. 4 (, 5 , 6 )

 

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of vascular
endothelial growth factor receptor ("VEGFR") -1, -2 and -3. VEGFR inhibitors
play a pivotal role in blocking tumor angiogenesis. Fruquintinib was designed
to improve kinase selectivity with the intention of minimizing off-target
toxicities, improving tolerability and providing more consistent target
coverage. Fruquintinib has been generally well tolerated in patients to date
and is being investigated in combinations with other anti-cancer therapies.

 

Fruquintinib was approved for marketing by the NMPA in September 2018 and
commercially launched in China in November 2018 under the brand name
ELUNATE(®) for the treatment of patients with metastatic colorectal cancer
("CRC") who have been previously treated with fluoropyrimidine, oxaliplatin
and irinotecan, including those who have previously received anti-VEGF therapy
and/or anti-epidermal growth factor receptor (EGFR) therapy (RAS wild type).
It has been included in the National Reimbursement Drug List ("NRDL") since
January 2020.

 

The safety and efficacy of fruquintinib for the following investigational uses
have not been established and there is no guarantee that it will receive
health authority approval or become commercially available in any country for
the uses being investigated.

 

Filing of a rolling submission of NDA to the U.S. Food and Drug Administration
("FDA") was accepted (https://www.hutch-med.com/fruq-nda-acceptance/) and
granted priority review in May 2023 with a Prescription Drug User Fee Act
(PDUFA) date of November 30, 2023. Submission to the European Medicines Agency
(EMA) was validated (https://www.hutch-med.com/fruquintinib-ema-validation/)
in June 2023, and submission to the Japan Pharmaceuticals and Medical Devices
Agency (PMDA) is expected to be completed in 2023. The submissions to the FDA
and the EMA include results from the Phase III FRESCO-2 trial along with data
from the Phase III FRESCO trial conducted in China. FRESCO-2 is a global Phase
III multi-regional clinical trial (MRCT) conducted in the U.S., Europe, Japan
and Australia investigating fruquintinib plus best supportive care ("BSC") vs.
placebo plus BSC in patients with previously treated metastatic CRC. The
FRESCO-2 trial met its primary and key secondary endpoints, showing a
significant and clinically meaningful improvement in OS and PFS, respectively.
Fruquintinib has been generally well tolerated in patients to date
(NCT04322539 (https://clinicaltrials.gov/ct2/show/NCT04322539) ). 7 

 

An NDA to the NMPA was accepted
(https://www.hutch-med.com/nda-acceptance-in-china-for-fruquintinib-in-2l-gastric-cancer/)
in April 2023 for fruquintinib in combination with paclitaxel for the
treatment of second-line advanced gastric or gastroesophageal junction
adenocarcinoma. The NDA includes results from the Phase III FRUTIGA trial, a
study in China to evaluate fruquintinib combined with paclitaxel compared with
paclitaxel monotherapy in this patient population. Its dual-primary endpoints
were PFS and OS. The trial met the PFS endpoint at a statistically and
clinically meaningful level, and while there was an improvement in median OS,
the OS endpoint was not statistically significant. Statistically significant
improvements were also shown in secondary endpoints including ORR, DCR and
duration of response (DoR). The safety profile was consistent with previously
reported studies (NCT03223376
(https://clinicaltrials.gov/ct2/show/NCT03223376) ).

 

HUTCHMED is also developing fruquintinib in China for the treatment of
multiple other solid tumor cancers in combination with anti-PD-1 monoclonal
antibodies. Fruquintinib is licensed to Takeda Pharmaceutical Company Limited
outside of China. HUTCHMED markets fruquintinib in China in partnership with
Eli Lilly and Company.

 

About Sintilimab

Sintilimab, marketed as TYVYT(®) (sintilimab injection) in China, is a PD-1
immunoglobulin G4 monoclonal antibody co-developed by Innovent Biologics, Inc.
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  Innovent is currently conducting more than 20 clinical
studies of sintilimab to evaluate its safety and efficacy in a wide variety of
cancer indications, including more than 10 registrational or pivotal clinical
trials.

 

In China, sintilimab has been approved for seven indications and included in
the NRDL for six indications.

 

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 oncology drugs now approved and marketed in China. 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 in combination with sintilimab for the
treatment of patients with advanced EMC 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 in combination with sintilimab for the
treatment of patients with advanced EMC 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 COVID-19 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.

 

CONTACTS
 Investor Enquiries
 Mark Lee, Senior Vice President                                   +852 2121 8200
 Annie Cheng, Vice President                                       +1 (973) 306-4490

 Media Enquiries
 Americas - Brad Miles, Solebury Strategic Communications          +1 (917) 570 7340 (Mobile) / bmiles@s (mailto:bmiles@soleburystrat.com)
                                                                   oleburystrat (mailto:bmiles@soleburystrat.com) .com
                                                                   (mailto:bmiles@soleburystrat.com)
 Europe - 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)
 Asia - 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  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  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  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  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  Siegel RL, et al. Cancer statistics, 2023. CA Cancer J Clin.
2023;73(1):17-48. DOI:10.3322/caac.21763.

 7  Dasari NA, et al. Fruquintinib versus placebo in patients with refractory
metastatic colorectal cancer (FRESCO-2): an international, multicentre,
randomised, double-blind, phase 3 study [published online ahead of print, 2023
Jun 15]. Lancet. 2023. DOI: 10.1016/S0140-6736(23)00772-9.

 8  Wang J, Fei K, Jing H, 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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