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Hutchmed (China) Limited
10 December 2021
Press Release
HUTCHMED Highlights Surufatinib and Toripalimab Combination
Clinical Data being Presented at the ESMO Immuno-Oncology 2021
Meeting
Hong Kong, Shanghai & Florham Park, NJ - Friday , December
10, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM:HCM;
HKEX:13) today announces that new analyses and updates on the
ongoing studies of surufatinib combined with toripalimab, in
multiple disease settings, presented at the European Society for
Medical Oncology's (ESMO) Immuno-Oncology Congress 2021, taking
place virtually on December 8-11, 2021.
Further details of the poster presentations are as follows:
Title: Surufatinib plus toripalimab in patients with advanced
small cell lung cancer (SCLC) after failure of 1L
systemic chemotherapy
First Author: Ying Cheng, MD, Jilin Cancer Hospital
Abstract No. &
Link: 157P
Date & Time: Thursday, December 9, 2021, 11:30am - 11:50am CET
Title: Surufatinib plus toripalimab for 2L treatment of
advanced gastric or gastro-esophageal junction (G/GEJ)
adenocarcinoma, esophageal squamous cell carcinoma
(ESCC) and neuroendocrine carcinoma (NEC): A multicenter,
single-arm phase II study
First Author: Ming Lu, MD, Peking University Cancer Hospital &
Institute
Abstract No. &
Link: 155P
Date & Time: Thursday, December 9, 2021, 10:50am - 11:10am CET
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
Extra-pancreatic Neuroendocrine Tumors ("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 [1] . 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%).
Pancreatic Neuroendocrine Tumors ("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 [2] ,
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 toripalimab, tislelizumab and sintilimab, which are
approved as mono-therapies in China.
NETs in the U.S. and Europe : A U.S. Food and Drug
Administration ("FDA") New Drug Application (NDA) submission was
accepted in June 2021, followed by a Marketing Authorisation
Application (MAA) submission to the European Medicines Agency (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 Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed by
Junshi Biosciences. More than thirty company-sponsored toripalimab
clinical studies covering more than fifteen indications have been
conducted globally, including in China, the United States,
Southeast Asia, and European countries. Ongoing or completed
pivotal clinical trials evaluating the safety and efficacy of
toripalimab cover a broad range of tumor types including cancers of
the lung, nasopharynx, esophagus, stomach, bladder, breast, liver,
kidney and skin.
In China, toripalimab was the first domestic anti-PD-1
monoclonal antibody approved for marketing (approved in China as
TUOYI(R) ). T o date, four indications of toripalimab has been
approved by the NMPA for the treatment of melanoma, nasopharyngeal
carcinoma ("NPC") and urothelial carcinoma. In the United States,
the FDA has granted priority review for the toripalimab Biologics
License Application (BLA) for the treatment of NPC, which currently
has no FDA-approved immuno-oncology treatment options. Earlier, the
FDA granted 2 Breakthrough Therapy designations, 1 Fast Track
designation, 4 Orphan Drug designations for toripalimab.
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 more than 4,500 personnel across all
its companies, at the center of which is a team of over 1,400 in
oncology/immunology. Since inception it has advanced eleven cancer
drug candidates from in-house discovery into clinical studies
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 surufatinib for patients, its expectations as to
whether any studies on surufatinib would meet their primary or
secondary endpoints, and its expectations as to the timing of the
completion and the release of results from such studies.
Forward-looking statements involve risks and uncertainties. Such
risks and uncertainties include, among other things, assumptions
regarding enrollment rates and the timing and availability of
subjects meeting a study's inclusion and exclusion criteria;
changes to clinical protocols or regulatory requirements;
unexpected adverse events or safety issues; the ability of
surufatinib, including as a combination therapy, to meet the
primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions and to gain commercial
acceptance after obtaining regulatory approval; the potential
market of surufatinib for a targeted indication; the sufficiency of
funding; 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 toripalimab, tislelizumab or
sintilimab as combination therapeutics, such risks and
uncertainties include assumptions regarding their safety, efficacy,
supply and continued regulatory approval. 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, The Stock
Exchange of Hong Kong Limited and on AIM. 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] 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. Lancet Oncol.
2020;21(11):1500-1512. doi: 10.1016/S1470-2045(20)30496-4 .
[2] 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. Lancet Oncol.
2020; 21(11):1489-1499. doi: 10.1016/S1470-2045(20)30493-9 .
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