REG - Hutchmed China Ltd - MAA of Fruquintinib Validated by the EMA

HUTCHMED (China)Announcement

15/06/2023 15:45

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RNS Number : 8943C  Hutchmed (China) Limited  15 June 2023

Press Release

 

Takeda and HUTCHMED Announce Marketing Authorization Application of Fruquintinib for Previously Treated Metastatic Colorectal Cancer Validated by the European Medicines Agency

 

- Application Includes Data from Phase III FRESCO-2 and FRESCO Clinical
Trials, which Demonstrated Superiority of Fruquintinib Plus Best Supportive
Care ("BSC") vs. Placebo plus BSC for Adult Patients with Previously Treated
Metastatic Colorectal Cancer -

Osaka, Japan, Cambridge, MA, Hong Kong, Shanghai & Florham Park, NJ -
Thursday, June 15, 2023: Takeda (TSE:4502/NYSE:TAK
(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Finvestors%2F&esheet=52286207&newsitemid=20200915005224&lan=en-US&anchor=TSE%3A4502%2FNYSE%3ATAK&index=2&md5=b7076f2bbb02ad331cdf76657f8aa07f)
) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) ("HUTCHMED
(https://www.hutch-med.com/) ") today announced that the European Medicines
Agency ("EMA") has validated and accepted for regulatory review the marketing
authorization application ("MAA") for fruquintinib, a highly selective and
potent inhibitor of vascular endothelial growth factor receptors ("VEGFR") -1,
-2 and -3 for the treatment of adult patients with previously treated
metastatic colorectal cancer ("CRC"). If approved, fruquintinib will be the
first and only highly selective inhibitor of all three VEGF receptors approved
in the E.U. for previously treated metastatic CRC. 1 (, 2 )

 

"European patients with metastatic colorectal cancer have not benefitted from
a treatment advancement in over a decade," said Awny Farajallah, M.D., head of
Global Medical Affairs Oncology at Takeda. "We are thrilled to have submitted
the marketing authorization application to the EMA, bringing us one step
closer to potentially offering this innovative therapy to patients with
advanced disease. We believe fruquintinib has the potential to address the
longstanding unmet need for patients with previously treated metastatic
colorectal cancer regardless of their biomarker status, and we look forward to
working with the regulators throughout the process."

 

The MAA for fruquintinib includes 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 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 overall survival ("OS")
and progression-free survival ("PFS"), respectively. Fruquintinib has been
generally well tolerated in patients to date.

 

"Based on fruquintinib's clinical profile to date, we are optimistic about its
potential as a choice for patients and physicians in the E.U. who find
treatment options to be limited for previously treated metastatic colorectal
cancer," said Dr. Michael Shi, Head of R&D and Chief Medical Officer,
HUTCHMED. "We believe the EMA validation of the marketing authorization
application for fruquintinib represents an exciting initial step toward
advancing treatment for patients in Europe and look forward to supporting
Takeda as it pursues this goal."

 

The validation follows the acceptance
(https://www.hutch-med.com/fruq-nda-acceptance/) by the U.S. Food and Drug
Administration ("FDA") of a new drug application ("NDA"), announced on May 25,
2023, which was granted Priority Review and assigned Prescription Drug User
Fee Act (PDUFA) goal date of November 30, 2023. Submission of an NDA to the
Japan Pharmaceuticals and Medical Devices Agency (PMDA) is also planned in
2023. Fruquintinib is currently approved in China under the brand name
ELUNATE(®). Approval in China was based on the results of the FRESCO study, a
Phase III pivotal registration trial of fruquintinib in 416 patients with
metastatic CRC in China, published in The Journal of the American Medical
Association, JAMA, in June 2018 (NCT02314819
(https://clinicaltrials.gov/ct2/show/NCT02314819) ). 3  In March 2023,
HUTCHMED and Takeda closed
(https://www.hutch-med.com/closing-of-fruquintinib-license-to-takeda-outside-china/)
an exclusive licensing agreement to further the global development,
commercialization and manufacture of fruquintinib outside of China.

 

About Fruquintinib

Fruquintinib is a highly selective and potent oral inhibitor of 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.

 

About FRESCO-2

The FRESCO-2 study is a multi-regional clinical trial conducted in the U.S.,
Europe, Japan and Australia investigating fruquintinib plus BSC vs placebo
plus BSC in patients with previously treated metastatic CRC. As previously
disclosed (https://www.hutch-med.com/fresco-2-met-primary-endpoint/) , the
691-patient study met its primary endpoint of OS in patients with metastatic
CRC who had progressed on standard chemotherapy and relevant biologic agents
and who had progressed on, or were intolerant to, TAS-102 and/or regorafenib.
In addition to OS, a statistically significant improvement in PFS, a key
secondary endpoint, was observed. Fruquintinib has been generally well
tolerated in patients to date. Summary results were initially presented at the
European Society for Medical Oncology (ESMO) Congress in September
2022.(( 4 )) Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT04322539
(https://clinicaltrials.gov/ct2/show/NCT04322539) .

 

About CRC

CRC is a cancer that starts in either the colon or rectum. According to the
International Agency for Research on Cancer, CRC is the third most prevalent
cancer worldwide, associated with more than 935,000 deaths in 2020. 5  In the
U.S., it is estimated that 153,000 patients will be diagnosed with CRC and
53,000 deaths from the disease will occur in 2023. 6  In Europe, CRC was the
second most common cancer in 2020 with approximately 520,000 new cases and
245,000 deaths. In Japan, CRC was the most common cancer with an estimated
148,000 new cases and 60,000 deaths in 2020.(5) Although early-stage CRC can
be surgically resected, metastatic CRC remains an area of high unmet need with
poor outcomes and limited treatment options. Some patients with metastatic CRC
may benefit from personalized therapeutic strategies based on molecular
characteristics; however, most patients have tumors that do not harbor
actionable mutations. 7 (, 8 , 9 , 10 , 11 )

 

About Takeda

Takeda is focused on creating better health for people and a brighter future
for the world. We aim to discover and deliver life-transforming treatments in
our core therapeutic and business areas, including gastrointestinal and
inflammation, rare disease, plasma-derived therapies, neuroscience, oncology
and vaccines. Together with our partners, we aim to improve the patient
experience and advance a new frontier of treatment options through our dynamic
and diverse pipeline. As a leading values-based, R&D-driven
biopharmaceutical company headquartered in Japan, we are guided by our
commitment to patients, our people and the planet. Our employees in
approximately 80 countries and regions are driven by our purpose and are
grounded in the values that have defined us for more than two centuries. For
more information, visit www.takeda.com (http://www.takeda.com/) .

 

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 (http://www.hutch-med.com/)
or follow us on LinkedIn (https://www.linkedin.com/company/hutchmed/) .

 

Takeda Media Contacts
Japanese Media

Jun Saito

Jun.Saito@takeda.com (mailto:Jun.Saito@takeda.com)

 

U.S. and International Media

Sara Noonan

Sara.Noonan@takeda.com (mailto:Sara.Noonan@takeda.com)

+1 (508) 566-2408

 

Emma Nash

Emma.Nash@takeda.com (mailto:Emma.Nash@takeda.com)

+1 (404) 927-9113

 

HUTCHMED 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

 

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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
submission of a MAA for fruquintinib for the treatment of CRC with the EMA and
the timing of such submission, the therapeutic potential of fruquintinib for
the treatment of patients with CRC 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 timing and outcome of clinical studies and
the sufficiency of clinical data to support MAA approval of fruquintinib for
the treatment of patients with CRC or other indications in the E.U. or other
jurisdictions such as the U.S. or Japan, its potential to gain approvals from
regulatory authorities on an expedited basis or at all; the efficacy and
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; each party's ability to satisfy the
terms and conditions under the license agreement; actions of regulatory
agencies, which may affect the initiation, timing and progress of clinical
trials or the regulatory pathway for fruquintinib; Takeda's ability to
successfully develop and commercialize fruquintinib; 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 as combination therapeutics with fruquintinib, such risks and
uncertainties include assumptions regarding the safety, efficacy, supply and
continued regulatory approval of these therapeutics. Such forward-looking
statements include, without limitation, statements regarding the plan to
develop and commercialize fruquintinib under the license agreement; potential
payments under the license agreement, including the upfront payment and any
milestone or royalty payments; potential benefits of the license agreement;
and HUTCHMED's strategy, goals and anticipated milestones, business plans and
focus. 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.

 

Takeda 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.

 

 1  Xu X, et al. Efficacy and safety of regorafenib and fruquintinib as
third-line treatment for colorectal cancer: a narrative review. Transl Cancer
Res. 2022;11(1):276-287. doi:10.21037/tcr-20-3539.

 2  Sun  Q, et al. Discovery of fruquintinib, a potent and highly selective
small molecule inhibitor of VEGFR 1, 2, 3 tyrosine kinases for cancer therapy,
Cancer Biol Ther. 2014;15:12, 1635-1645. doi:10.4161/15384047.2014.964087.

 3  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.

 4  Dasari NA, et al. LBA25 - FRESCO-2: A global phase III multiregional
clinical trial (MRCT) evaluating the efficacy and safety of fruquintinib in
patients with refractory metastatic colorectal cancer. Ann Oncol. 2022
Sep;33(suppl_7): S808-S869. doi:10.1016/annonc/annonc1089.

 5  Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of
Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J
Clin. 2021;71(3):209-249. doi:10.3322/caac.21660.

 6  Siegel RL, et al. Colorectal cancer statistics, 2023 [published online
ahead of print, 2023 Mar 1]. CA Cancer J Clin. 2023; 73(3):233-254.
doi:10.3322/caac.21772.

 7  Bando H, et al. Therapeutic landscape and future direction of metastatic
colorectal cancer. Nat Rev Gastroenterol Hepatol. 2023;20(5):306-322.
doi:10.1038/s41575-022-00736-1.

 8  D'Haene N, et al. Clinical application of targeted next-generation
sequencing for colorectal cancer patients: a multicentric Belgian experience.
Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17.
doi:10.18632/oncotarget.25099.

 9  Venderbosch, et al. Mismatch repair status and braf mutation status in
metastatic colorectal cancer patients: A pooled analysis of the Cairo, Cairo2,
coin, and Focus Studies. Clinical Cancer Res. 2014;20(20):5322-5330.
doi:10.1158/1078-0432.ccr-14-0332.

 10  Koopman, M., et al. Deficient mismatch repair system in patients with
sporadic advanced colorectal cancer. Br J Cancer. 2009;100(2):266-273.
doi:10.1038/sj.bjc.6604867.

 11  Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and
Winding Road From Negative Predictive Factor to Positive Actionable Target. Am
Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.

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