Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited
(Nasdaq/AIM:HCM, HKEX:13) (“HUTCHMED”) today announced that the
U.S. Food and Drug Administration (“FDA”) has granted priority
review of the New Drug Application (“NDA”) 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 U.S. for previously treated metastatic CRC.1,2 The
Prescription Drug User Fee Act (PDUFA) goal date assigned by the
FDA for this NDA is November 30, 2023.
“We are confident that fruquintinib has the
potential to transform the treatment landscape for those living
with previously treated metastatic colorectal cancer, as
demonstrated by its strong clinical profile,” said Awny Farajallah,
M.D., head of Global Medical Affairs Oncology at Takeda. “There are
significant needs for patients with this disease in the U.S., and
we believe fruquintinib has the potential to address these needs
regardless of patients’ biomarker status. We look forward to
continuing conversations with the FDA with the goal to make this
therapy available to patients as soon as possible.”
The NDA 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 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 overall survival (“OS”) and
progression-free survival (“PFS”), respectively. Fruquintinib has
been generally well tolerated in patients to date.
“The clinical benefit of fruquintinib has been
confirmed in multiple ways, from global clinical studies to
commercialization in China. We are pleased to have Takeda as our
partner furthering development and commercialization of
fruquintinib outside of China,” said Dr. Michael Shi, Head of
R&D and Chief Medical Officer, HUTCHMED. “Today’s acceptance
marks a significant advancement towards the goal of providing
patients with previously treated metastatic colorectal cancer a
much-needed therapeutic option, given the limited treatment options
currently available to patients. This also supports our ongoing
vision to design and develop differentiated molecules that help
patients with high unmet needs globally.”
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).3 In March 2023, HUTCHMED and Takeda
closed 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,
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.
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 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 2020.6 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.
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 or follow us on
LinkedIn.
Takeda Media
Contacts:
Japanese
Media Jun
Saito Jun.Saito@takeda.com
U.S. and International
Media Sara
Noonan Sara.Noonan@takeda.com
+1
(508) 566-2408
Emma Nash 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@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 |
Asia – Zhou Yi, Brunswick |
+852 9783 6894 (Mobile) /
HUTCHMED@brunswickgroup.com |
|
|
Nominated Advisor |
|
Atholl Tweedie / Freddy Crossley / Daphne Zhang Panmure Gordon |
+44 (20) 7886 2500 |
|
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Takeda does not undertake to update any of the forward-looking
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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 NDA for fruquintinib for the treatment of CRC with
the FDA 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 NDA
approval of fruquintinib for the treatment of patients with CRC or
other indications in the U.S. or other jurisdictions such as Europe
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-20-35392 Sun Q, et al.
(2014) 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:
10.4161/15384047.2014.9640873 Li J, Qin S, Xu RH, 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. 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.216606 Siegel RL, al.
Colorectal cancer statistics, 2023 [published online ahead of
print, 2023 Mar 1]. CA Cancer J Clin. 2023;10.3322/caac.21772.
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future direction of metastatic colorectal cancer. Nat Rev
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D'Haene N, et al. Clinical application of targeted next-generation
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experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr
17. doi:10.18632/oncotarget.250999 Venderbosch, et al. (2014).
Mismatch repair status and braf mutation status in metastatic
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M., et al. (2009). Deficient mismatch repair system in patients
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Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and
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Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14.
doi:10.1200/EDBK_351354
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