TIDMHCM
RNS Number : 7938A
Hutchmed (China) Limited
26 May 2023
Press Release
Takeda and HUTCHMED Announce New Drug Application (NDA) for
Fruquintinib for Treatment of Previously Treated Metastatic
Colorectal Cancer
Granted Priority Review
- Prescription Drug User Fee Act (PDUFA) Target Action Date set
for November 30, 2023 -
- NDA includes results from the Phase III FRESCO-2 and FRESCO
clinical trials -
OSAKA, Japan, CAMBRIDGE, Massachusetts, HONG KONG, SHANGHAI
&, FLORHAM PARK, New Jersey, Friday May 26, 2023 - 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(R) . 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.(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.
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@s oleburystrat .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 97 83 6894 (Mobile) / HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley / Daphne Zhang
Panmure Gordon +44 (20) 7886 2500
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and the timing of any such divestment(s); and other factors
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Takeda's other reports filed with the U.S. Securities and Exchange
Commission, available on Takeda's website at:
https://www.takeda.com/investors/sec-filings/ or at www.sec.gov.
Takeda does not undertake to update any of the forward-looking
statements contained in this press release or any other
forward-looking statements it may make, except as required by law
or stock exchange rule. Past performance is not an indicator of
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press release may not be indicative of, and are not an estimate,
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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-20-3539
[2] 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: 10.4161/15384047.2014.964087
[3] 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.21660
[6] Siegel RL, al. Colorectal cancer statistics, 2023 [published
online ahead of print, 2023 Mar 1]. CA Cancer J Clin.
2023;10.3322/caac.21772. doi:10.3322/caac.21772
[7] Bando H, et al. Therapeutic landscape and future direction
of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol
(2023). 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. (2014). 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 Research, 20(20), 5322-5330.
https://doi.org/10.1158/1078-0432.ccr-14-0332
[10] Koopman, M., et al. (2009). Deficient mismatch repair
system in patients with sporadic advanced colorectal cancer.
British Journal of Cancer, 100(2), 266-273.
https://doi.org/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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