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 gastroesophageal 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®. 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 Oncology1. 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 Oncology2, 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 monotherapies 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®). To 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, Solebury Trout |
+1 (917) 570 7340 (Mobile)
bmiles@troutgroup.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 |
|
|
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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