TIDMHCM
Hutchmed (China) Limited
20 September 2021
Press Release
HUTCHMED Initiates a Japan Bridging Study to Support Surufatinib
Registration for Advanced Neuroendocrine Tumors
- Following surufatinib launch in China in January 2021; NDA
acceptance by the U.S. FDA for review in June 2021; and MAA
validation by the EMA in July 2021 all for advanced neuroendocrine
tumors -
Hong Kong, Shanghai & Florham Park, NJ - Monday, September
20, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM;
HKEX: 13) today announces that it has initiated a Japan
registration-enabling bridging study for surufatinib to support the
registration of surufatinib in the treatment of patients with
advanced neuroendocrine tumors ("NETs"). The first patient was
dosed on September 15, 2021.
Based on dialogue with the Japanese Pharmaceuticals and Medical
Devices Agency (PMDA), it was agreed that the surufatinib Japanese
new drug application ("NDA") for the treatment of advanced NETs
include results from a pivotal study to be conducted in Japan, to
complement the registration data package supporting the NDA to the
U.S. Food and Drug Administration ("FDA") (accepted for review in
June 2021) and the Marketing Authorization Application ("MAA") to
the European Medicines Agency ("EMA") (validated in July 2021). The
basis for the NDA and the MAA includes data from a U.S. Phase I/II
study, as well as the completed Phase III SANET-ep and SANET-p
studies used to support marketing authorization in China in
advanced NETs, where surufatinib is currently marketed under the
brand name SULANDA(R) .
This Japan study is a two-stage, open label study of surufatinib
where approximately 34 patients are expected to be recruited. In
Part 1 of the study, the safety and tolerability of surufatinib
300mg once daily after 28 days of treatment will be assessed in
patients with relapsed/refractory non-hematological malignancies;
pharmacokinetics ("PK") and anti-tumor activity of surufatinib are
secondary endpoints. In Part 2 of the study, efficacy will be
assessed in patients with locally advanced or metastatic NETs; the
primary outcome measure is objective response rate (ORR). The
secondary outcome measures include disease control rate (DCR),
progression free survival ("PFS"), duration of response (DoR),
safety, and PK.
Surufatinib is the third potential new medicine discovered by
HUTCHMED to enter into clinical development in Japan. A global
Phase III registration study for fruquintinib, known as the
FRESCO-2 study, is ongoing in patients with refractory metastatic
colorectal cancer and is expected to enroll over 680 patients from
over 150 sites in 14 countries, including Japan. A global
single-arm, open-label study, known as the SAVANNAH study, is
ongoing for savolitinib (partnered with AstraZeneca PLC) in
combination with TAGRISSO(R) in non-small cell lung cancer patients
whose disease progressed following TAGRISSO(R) due to MET
amplification or overexpression.
About NETs
NETs form in cells that interact with the nervous system or in
glands that produce hormones. They can originate in various parts
of the body, most often in the gut or the lungs and can be benign
or malignant. NETs are typically classified as pancreatic NET
("pNET") or extra-pancreatic (non-pancreatic) NET ("epNET").
According to Frost & Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2020. Rates across the
European Union (E.U.) appear largely similar to the U.S. This is
supported by an analysis of global epidemiologic trends, which also
show growth in the incidence of NETs worldwide.[1] Importantly,
NETs are associated with a relatively long duration of survival
compared to other tumors. As a result, there were approximately
140,000 estimated patients living with NET in France, Germany,
Italy, Spain, and the United Kingdom in 2020.[2] In Japan,
approximately 6,700 people were diagnosed with
gastro-entero-pancreatic neuroendocrine neoplasms in 2016.[3]
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptors (VEGFR) and fibroblast
growth factor receptor (FGFR), which both inhibit angiogenesis, and
colony stimulating factor-1 receptor (CSF-1R), which regulates
tumor-associated macrophages, promoting the body's immune response
against tumor cells. Its unique dual mechanism of action may be
very suitable for possible combinations with other immunotherapies,
where there may be synergistic anti-tumor effects.
HUTCHMED currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
epNETs in China : On December 29, 2020, surufatinib was granted
drug registration approval by the National Medical Products
Administration of China ("NMPA") for the treatment of epNET.
Surufatinib is marketed in China under the brand name SULANDA(R) .
The approval was based on results from the SANET-ep study, a Phase
III trial (clinicaltrials.gov identifier: NCT02588170) in patients
with advanced epNETs conducted in China. The study met the
pre-defined primary endpoint of PFS at a preplanned interim
analysis, and was published in The Lancet Oncology [4] . Median PFS
was significantly longer for patients treated with surufatinib at
9.2 months, compared to 3.8 months for patients in the placebo
group (HR 0.334; 95% CI: 0.223-0.499; p<0.0001). Surufatinib had
an acceptable safety profile, with the most common treatment
related adverse events of grade 3 or worse being hypertension (36%
of surufatinib patients vs. 13% of placebo patients), proteinuria
(19% vs. 0%) and anemia (5% vs. 3%).
pNETs in China : On June 16, 2021, surufatinib was granted drug
registration approval by the NMPA for the treatment of pNET. The
approval was based on results from the SANET-p study, a Phase III
trial (clinicaltrials.gov identifier: NCT02589821) in patients with
advanced pNET in China. The pre-defined primary endpoint of PFS was
met at a preplanned interim analysis and was published in The
Lancet Oncology [5] , demonstrating that surufatinib reduces the
risk of disease progression or death by 51% in patients, with a
median PFS of 10.9 months compared to 3.7 months on placebo (HR
0.491; 95% CI: 0.391-0.755; p=0.0011). The safety profile of
surufatinib was manageable and consistent with observations in
prior studies.
Immunotherapy combinations: HUTCHMED entered into collaboration
agreements to evaluate the safety, tolerability and efficacy of
surufatinib in combination with anti-PD-1 monoclonal antibodies,
including with tislelizumab (BGB-A317), TUOYI (R) (toripalimab) and
TYVYT (R) (sintilimab), which are approved as monotherapies in
China.
NETs in the U.S. and Europe : A FDA NDA submission was accepted
in June 2021, followed by a MAA submission to the EMA validated in
July 2021. The basis to support these filings includes the
completed SANET-ep and SANET-p studies, along with existing data
from surufatinib in U.S. epNET and pNET patients
(clinicaltrials.gov identifier: NCT02549937 ). In the U.S.,
surufatinib was granted Fast Track Designations for development in
pNET and epNET in April 2020, and Orphan Drug Designation for pNET
in November 2019.
HUTCHMED has initiated an Expanded Access Protocol (EAP) in the
U.S. to ensure patients with NET with limited therapeutic options
have access to this treatment. Regulatory clearance of this
protocol has been granted by the FDA and this program is open for
site activation (clinicaltrials.gov identifier: NCT04814732).
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM; HKEX: 13) is an innovative,
commercial-stage, biopharmaceutical company. It is committed to the
discovery, global development and commercialization of targeted
therapies and immunotherapies for the treatment of cancer and
immunological diseases. A dedicated organization of over 1,400
personnel has advanced eleven cancer drug candidates from in-house
discovery into clinical studies around the world, with its first
three oncology drugs now approved. 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 surufatinib for the treatment of patients with NET and
the further clinical development of surufatinib 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 surufatinib for the treatment of patients
with NET in the U.S., China, Japan and other jurisdictions such as
the E.U., its potential to gain expeditious approvals from
regulatory authorities, the safety profile of surufatinib,
HUTCHMED's ability to fund, implement and complete its further
clinical development and commercialization plans for surufatinib,
the timing of these events, 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 capecitabine,
tislelizumab, TUOYI(R) , and TYVYT(R) as combination therapeutics
with surufatinib, 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
Investor Enquiries
Mark Lee, Senior Vice President +852 2121 8200
Annie Cheng, Vice President +1 (973) 567 3786
Media Enquiries
Americas - Brad Miles, +1 (917) 570 7340 (Mobile)
Solebury Trout bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile)
FTI Consulting HUTCHMED@fticonsulting.com
Asia - Zhou Yi, +852 97 83 6894 (Mobile)
Brunswick HUTCHMED@brunswickgroup.com
Nominated Advisor
Atholl Tweedie / Freddy Crossley,
Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] Fraenkel M, Kim M, Faggiano A, de Herder WW, Valk GD;
Knowledge NETwork. Incidence of gastroenteropancreatic
neuroendocrine tumours: a systematic review of the literature.
Endocr Relat Cancer. 2014;21(3):R153-R163. Published 2014 May 6.
doi: 10.1530/ERC-13-0125.
[2] According to Frost & Sullivan, in 2020, there were
19,000 newly diagnosed cases of NETs in the U.S. and an estimated
143,000 patients living with NETs. Report on file.
[3] Masui T, Ito T, Komoto I, Uemoto S; JNETS Project Study
Group. Recent epidemiology of patients with
gastro-entero-pancreatic neuroendocrine neoplasms (GEP-NEN) in
Japan: a population-based study. BMC Cancer. 2020;20(1):1104.
Published 2020 Nov 14. doi: 10.1186/s12885-020-07581-y.
[4] Xu J, Shen L, Zhou Z, et al. Surufatinib in advanced
extrapancreatic neuroendocrine tumours (SANET-ep): a randomised,
double-blind, placebo-controlled, phase 3 study [published online
ahead of print, 2020 Sep 20]. Lancet Oncol. 2020;
S1470-2045(20)30496-4. doi:10.1016/S1470-2045(20)30496-4 .
[5] Xu J, Shen L, Bai C, et al. Surufatinib in advanced
pancreatic neuroendocrine tumours (SANET-p): a randomised,
double-blind, placebo-controlled, phase 3 study [published online
ahead of print, 2020 Sep 20]. Lancet Oncol. 2020;
S1470-2045(20)30493-9. doi: 10.1016/S1470-2045(20)30493-9 .
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