TIDMHCM
Hutchmed (China) Limited
31 March 2023
Press Release
HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for
Fruquintinib for the Treatment of Refractory Metastatic Colorectal
Cancer
- NDA supported by data from global Phase III FRESCO-2 study in
the U.S., Europe, Japan and Australia along with data from Phase
III FRESCO study conducted in China -
- FRESCO-2 showed fruquintinib treatment reduced the risk of
death by 34% in refractory metastatic colorectal cancer (0.66 HR),
consistent with the 35% reduction in the risk of death seen in
FRESCO -
- Marketing authorization submissions in Europe and Japan on
track to complete in 2023 -
Hong Kong, Shanghai & Florham Park, NJ - Friday, March 31,
2023: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM,
HKEX:13) today announces that it completed the rolling submission
of a New Drug Application ("NDA") to the U.S. Food and Drug
Administration ("FDA") for fruquintinib, its highly selective and
potent oral inhibitor of VEGFR-1, -2 and -3, for the treatment of
refractory metastatic colorectal cancer ("CRC").
"This FDA submission is a significant milestone for patients in
the U.S. with metastatic CRC, one of the most common and deadly
cancers in the U.S. and worldwide. Fruquintinib is an important
treatment option for patients with metastatic CRC in China, where
it has been available to patients since 2018. We look forward to
working with our partner Takeda to commercialize fruquintinib
outside China, and we remain on track to submit regulatory filings
in Europe and Japan later this year," said Dr. Michael Shi, Head of
R&D and Chief Medical Officer of HUTCHMED.
The NDA is supported by the global Phase III multi-regional
clinical trial ("MRCT") FRESCO-2 study conducted in the U.S.,
Europe, Japan and Australia that investigated fruquintinib plus
best supportive care ("BSC") vs placebo plus BSC in patients with
refractory metastatic CRC, along with data from the FRESCO study
conducted in China. Filing of a Marketing Authorization Application
(MAA) to the European Medicines Agency (EMA) and an NDA to the
Japan Pharmaceuticals and Medical Devices Agency (PMDA) are planned
in 2023.
In March 2023, HUTCHMED and Takeda Pharmaceutical Company
Limited (TSE:4502, NYSE:TAK) closed an exclusive license agreement
to further the global development, commercialization and
manufacture of fruquintinib outside China. In China, fruquintinib
is approved under the brand name ELUNATE(R) and is included in the
China National Reimbursement Drug List ("NRDL"). HUTCHMED markets
fruquintinib in China in partnership with Eli Lilly and
Company.
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. [1] In the U.S., an estimated 153,000
patients were diagnosed with CRC and there were 53,000 deaths from
the disease in 2023. [2] In Europe, CRC was the second most common
cancer in 2020, with approximately 520,000 new cases and 245,000
deaths. In Japan, CRC is the most common cancer, with an estimated
148,000 new cases and 60,000 deaths in 2020.(1) Although early
stage CRC can be surgically resected, metastatic CRC remains an
area of high unmet need with poor outcomes and limited treatment
options.
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 Fruquintinib Approval in CRC in China
Fruquintinib was approved for marketing by the China National
Medical Products Administration (NMPA) in September 2018 and
commercially launched in China in November 2018 under the brand
name ELUNATE(R) . It has been included in the NRDL since January
2020. ELUNATE(R) is indicated for the treatment of patients with
metastatic 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). Results of
the FRESCO study [3] , a Phase III pivotal registration trial of
fruquintinib in 416 patients with metastatic CRC in China, were
published in The Journal of the American Medical Association, JAMA,
in June 2018 (NCT02314819). The primary endpoint of the study,
overall survival ("OS"), was achieved with a hazard ratio ("HR") of
0.65 (95% confidence interval ["CI"] 0.51-0.83; p<0.001)
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.
About the FRESCO-2 Phase III Trial in CRC Outside China
The FRESCO-2 study is a MRCT conducted in the U.S., Europe,
Japan and Australia that investigated fruquintinib plus BSC vs
placebo plus BSC in patients with refractory metastatic CRC
(NCT04322539 ). The results were presented at European Society for
Medical Oncology (ESMO) congress in September 2022. [4] The MRCT
FRESCO-2 study demonstrated that treatment with fruquintinib
resulted in a statistically significant and clinically meaningful
increase in the primary OS endpoint and key secondary progression
free survival ("PFS") endpoint compared to treatment with
placebo.
Specifically, the median OS was 7.4 months for the 461 patients
treated with fruquintinib compared to 4.8 months for the 230
patients in the placebo group (HR 0.66; 95% CI 0.55-0.80;
p<0.001). The median PFS was 3.7 months for patients treated
with fruquintinib compared to 1.8 months for patients in the
placebo group (HR 0.32; 95% CI 0.27-0.39; p<0.001). The disease
control rate ("DCR") was 55.5% in the fruquintinib group compared
to 16.1% for patients in the placebo group. Median duration of
follow-up was approximately 11 months for patients in both
groups.
The safety profile of fruquintinib in FRESCO-2 was consistent
with previously reported fruquintinib studies. Grade 3 or above
adverse events occurred in 62.7% of patients who received
fruquintinib, compared to 50.4% of patients who received placebo.
Grade 3 or above adverse events that occurred in more than 5% of
patients who received fruquintinib were hypertension (13.6% vs 0.9%
in the placebo group), asthenia (7.7% vs 3.9% in the placebo group)
and hand-foot syndrome (6.4% vs 0% in the placebo group). Treatment
related adverse events leading to discontinuation occurred in 20.4%
of patients who received fruquintinib, compared to 21.1% of
patients who received placebo.
About Other Fruquintinib Developments
Gastric Cancer in China: The FRUTIGA study is a randomized,
double-blind, Phase III study in China to evaluate fruquintinib
combined with paclitaxel compared with paclitaxel monotherapy, for
second-line treatment of advanced gastric cancer or
gastroesophageal junction adenocarcinoma (NCT03223376). Topline
results were announced in November 2022. The trial met one of the
primary endpoints of statistically significant improvement in PFS,
which is clinically meaningful. The other primary endpoint of OS
was not statistically significant per the pre-specified statistical
plan, although there was a numerical improvement in median OS.
Fruquintinib also demonstrated a statistically significant
improvement in secondary endpoints including objective response
rate (ORR), DCR, and improved duration of response (DoR). The
safety profile of fruquintinib in FRUTIGA was consistent with
previously reported studies. Results are expected to be disclosed
at an upcoming scientific meeting.
HUTCHMED is also developing fruquintinib for the treatment of
multiple solid tumor cancers in combination with PD-1 monoclonal
antibodies for the treatment of endometrial and other solid
tumors.
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.
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 an
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.
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 Trout +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,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] The Global Cancer Observatory. Accessed December 12,
2022.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html.
Accessed December 12, 2022.
[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, Lonardi S, 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.
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