TIDMHCM
Hutchmed (China) Limited
21 September 2021
Press Release
HUTCHMED Initiates SURTORI-01, a Phase III Trial of SULANDA(R)
in Combination with TUOYI(R) in the Treatment of Advanced
Neuroendocrine Carcinoma in China
Hong Kong, Shanghai & Florham Park, NJ - Tuesday, September
21, 2021: HUTCHMED (China) Limited ("HUTCHMED") (Nasdaq/AIM: HCM;
HKEX: 13) today announces that it has initiated SURTORI-01 , a
Phase III study to evaluate the efficacy and safety of sur ufatinib
(SULANDA(R) in China) in combination with tori palimab compared
with FOLFIRI to treat patients with advanced neuroendocrine
carcinoma ("NEC") who have progression of disease or intolerable
toxicity after previous first-line chemotherapy. The first patient
was dosed on September 18, 2021 in China. Toripalimab is marketed
as TUOYI(R) in China by Shanghai Junshi Biosciences Co., Ltd.
("Junshi Biosciences").
Professor Shen Lin, the lead principal investigator of the study
and Vice President of Peking University Hospital and Cancer
Institute, said: "There is a large unmet clinical need for patients
with NEC, many of whom have a bleak prognosis. Following the
encouraging preliminary data from the Phase II trial, we are
excited to move into the next stage of development in combining the
novel, oral angio-immuno kinase inhibitor surufatinib with the
anti-PD-1 antibody toripalimab. We look forward to further testing
the synergistic anti-tumor effects of this combination that could
benefit NEC patients who have limited treatment options."
At the American Society of Clinical Oncology (ASCO) 2021 Annual
Meeting, encouraging preliminary data from the Phase II trial were
disclosed for the surufatinib and toripalimab combination[1]. For
the 20 patients in the NEC cohort as of December 31, 2020, who
received an average of 5 cycles of treatments and are efficacy
evaluable, objective response rate ("ORR") was 20% and disease
control rate ("DCR") was 70%. Median progression-free survival
("PFS") was 3.9 months (95% CI: 1.3 - not reached). Grade 3 or
higher treatment-related adverse events occurred in 33% of
patients. Treatment related adverse events ("TRAEs") were
manageable, with surufatinib or toripalimab interruption occurred
in 6 (28.6%) and 4 (19%) patients respectively. There were neither
serious adverse events ("AEs") nor AEs inducing treatment
discontinuations or deaths. Updated data will be presented at the
Chinese Society of Clinical Oncology (CSCO) 2021 Annual Meeting in
late September.
The SURTORI-01 Phase III study is a randomized, controlled,
open-label, multi-center study where approximately 200 patients are
expected to be enrolled. For the study group, all patients will
receive study treatment in 21-day cycle and the treatment will
continue until there is a progression of disease, death,
intolerable toxicity, or the end of study treatment (as other
criteria specified in the protocol are met), whichever occurs
first. The primary outcome measure is OS. The secondary outcome
measures include PFS, ORR, duration of response (DoR), and DCR.
Additional details may be found at clinicaltrials.gov, using
identifier NCT05015621.
HUTCHMED is the sponsor of SURTORI-01 and responsible for all
clinical and regulatory execution of the Phase III study. HUTCHMED
and Junshi Biosciences are jointly funding the study.
Surufatinib is marketed in China under the brand name SULANDA(R)
for treating advanced neuroendocrine tumors ("NETs").
About NEC
Neuroendocrine neoplasms ("NEN") occur almost everywhere in the
body but are most common in the gastrointestinal tract, pancreas,
and lungs. NEC is one of the two common phenotypes of NEN. NECs are
poorly differentiated, highly proliferating NENs, while NETs are
well-differentiated, low-proliferating NENs. NECs are aggressive,
fast-growing neoplasms that usually fail to express hormones or
produce hormonal syndromes, and are not associated with hereditary
tumor diseases.[2]
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 NETs ("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 [3] . 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 NETs ("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 [4] ,
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 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 the first domestic anti-PD-1 monoclonal antibody
to obtain marketing approval in China. So far, more than thirty
company-sponsored clinical studies covering more than fifteen
indications have been conducted globally including in China and the
United States. On December 17, 2018, toripalimab was granted
conditional approval from the NMPA for the second-line treatment of
patients with unresectable or metastatic melanoma. In December
2020, toripalimab was successfully included in the updated National
Reimbursement Drug List. In February 2021, toripalimab received
NMPA's conditional approval for the treatment of patients with
recurrent or metastatic nasopharyngeal carcinoma ("NPC") after
failure of at least two lines of prior systemic therapy. In April
2021, toripalimab received NMPA's conditional approval for the
treatment of patients with locally advanced or metastatic
urothelial carcinoma who failed platinum-containing chemotherapy or
progressed within 12 months of neoadjuvant or adjuvant
platinum-containing chemotherapy. In addition, toripalimab has been
included in the Guidelines of the Chinese Society of Clinical
Oncology (CSCO) for the Diagnosis and Treatment of Melanoma, Head
and Neck Tumors, Urothelial Carcinoma and other indications.
In February 2021, the supplemental new drug application (the
"sNDA") of toripalimab in combination with cisplatin and
gemcitabine as the first-line treatment for patients with locally
recurrent or metastatic NPC was accepted for review by the NMPA. In
March 2021, toripalimab received Breakthrough Therapy Designation
for the first-line treatment of advanced mucosal melanoma by the
NMPA. In July 2021, the sNDA for toripalimab in combination with
platinum-containing chemotherapy as the first-line treatment for
patients with locally advanced or metastatic esophageal squamous
cell carcinoma was accepted for review by the NMPA.
In terms of international development, the first toripalimab
Biological License Application (BLA) has been submitted to the FDA
for the treatment of recurrent or metastatic NPC. The FDA has
granted two Breakthrough Therapy designations for toripalimab in
combination with chemotherapy for the first line treatment of
recurrent or metastatic NPC and also for toripalimab monotherapy in
second or third line treatment of recurrent or metastatic NPC.
Additionally, FDA has granted Fast Track designation for
toripalimab for the treatment of mucosal melanoma and orphan drug
designations for NPC, mucosal melanoma and soft tissue sarcoma.
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 NEC 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 NEC in the U.S., China 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] Shen L, Yu X, Lu M, et al. Surufatinib in combination with
toripalimab in patients with advanced neuroendocrine carcinoma:
Results from a multicenter, open-label, single-arm, phase II trial.
J Clin Oncol. 39 ,
2021 (suppl 15; abstr e16199). doi: 10.1200/ JCO.2021.39.15_suppl.e16199 .
[2] Klöppel G. Neuroendocrine Neoplasms: Dichotomy, Origin and
Classifications. Visc Med. 2017 ;33(5):324-330.
doi:10.1159/000481390.
[3] 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 .
[4] 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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