HUTCHMED (China) Limited (“HUTCHMED”) (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 pMMR1 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.
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 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 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).7
An NDA to the NMPA was accepted 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).
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 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
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 |
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Investor Enquiries |
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Mark Lee, Senior Vice President |
+852 2121 8200 |
Annie Cheng, Vice President |
+1 (973) 306-4490 |
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Media Enquiries |
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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 |
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Nominated Advisor |
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Atholl Tweedie / Freddy Crossley / Daphne Zhang,
Panmure Gordon |
+44 (20) 7886 2500 |
_____________________
1 pMMR = Mismatch Repair proficient2 The Global
Cancer Observatory, World Fact Sheet. Accessed June 12, 2023.3 The
Global Cancer Observatory, China Fact Sheet. 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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