TIDMHCM
Hutchison China Meditech Limited
24 March 2021
Press Release
HUTCHMED Initiates a Phase Ib/II Trial of Surufatinib in
Combination with Tislelizumab in Patients with Advanced Solid
Tumors
Hong Kong, Shanghai & Florham Park, NJ - Wednesday, March
24, 2021: Hutchison China MediTech Limited ("HUTCHMED")
(Nasdaq/AIM: HCM) has initiated a Phase Ib/II study of surufatinib
in combination with BeiGene's tislelizumab in patients with
advanced solid tumors in the U.S. and Europe. The first patient was
dosed on March 23, 2021. This trial is to explore potential
synergistic activity of the novel, oral angio-immuno kinase
inhibitor surufatinib with the anti-PD-1 antibody tislelizumab in
enhancing overall antitumor activity from inhibition of
angiogenesis along with stimulation of an immune response.
This is an open-label study to evaluate the safety,
tolerability, pharmacokinetics and efficacy of surufatinib in
combination with tislelizumab in patients with advanced solid
tumors. The study consists of two parts: dose finding (Part 1) and
dose expansion (Part 2). Part 1 will be conducted to determine the
recommended Phase II dose ("RP2D") and/or the maximum tolerated
dose (MTD) of surufatinib in combination with tislelizumab in
patients with advanced or metastatic solid tumors who have
progressed on, or are intolerant to, standard therapies. Part 2
will be an open-label, multi-cohort design to evaluate the
anti-tumor activity of surufatinib in combination with tislelizumab
in patients with specific types of advanced or metastatic solid
tumors, including neuroendocrine tumors, colorectal cancer, small
cell lung cancer, gastric cancer, and soft tissue sarcoma. Patients
will receive the RP2D determined in Part 1 of this study.
Additional details may be found at clinicaltrials.gov, using
identifier NCT04579757.
About Neuroendocrine Tumors ("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 non-pancreatic NET ("epNET"). Approved targeted
therapies include Sutent(R) (for pNET only) and Afinitor(R) for
pNET and well-differentiated, non-functional gastrointestinal or
lung NET.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of NETs in the U.S. in 2018. Importantly, NETs are
associated with a relatively long duration of survival compared to
other tumors. As a result, there were approximately 141,000
estimated patients living with NETs in the U.S. in 2018.
About Colorectal Cancer ("CRC")
CRC is cancer that starts in either the colon or rectum. CRC is
the third most common cancer worldwide, estimated to have caused
more than 935,000 deaths in 2020. [1] In the U.S., an estimated
150,000 people were diagnosed with CRC and 53,000 people died from
CRC in 2020. [2] In Europe, CRC is the second most common cancer,
with an estimated 507,000 new cases and 240,000 deaths in
2020.(4)
About Small Cell Lung Cancer ("SCLC")
Cancer of the lungs and bronchus were estimated to be diagnosed
in over 228,000 people in the U.S. and 477,000 people in Europe
during 2020. [3](, [4]) SCLC accounts for 10-15% of newly diagnosed
lung cancer cases. [5] SCLC carries a lower five-year survival rate
(6.6%) relative to lung cancer in general (20.5%).(3) (, [6])
About Gastric Cancer ("GC")
GC is cancer that starts in the stomach. In the U.S., an
estimated 27,000 people were diagnosed with GC during 2020, with
overall expected five-year survival rate of 32%. [7] In Europe, GC
was estimated to be diagnosed in 136,000 new patients and be the
cause of 97,000 deaths in 2020.(4)
About Soft Tissue Sarcoma ("STS")
STS is a heterogeneous group of tumors that start in different
soft tissues, such as muscles, tendons, and blood vessels. In the
U.S., an estimated 13,000 people were diagnosed with STS for during
2020, with overall five-year survival rate of 65%. [8] In Europe,
annual incidence of STS is estimated to be approximately 23,000.
[9]
About Surufatinib
Surufatinib is a novel, oral angio-immuno kinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
vascular endothelial growth factor receptor (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
NETs in the U.S. and Europe: 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. A U.S. FDA NDA rolling submission was initiated in December
2020 , to be followed by a marketing authorization application
(MAA) submission to the European Medicines Agency (EMA) in Europe.
The basis to support these filings includes the completed SANET-ep
[10] and SANET-p ([11]) studies, along with existing data from
surufatinib in U.S. epNET and pNET patients (clinicaltrials.gov
identifier: NCT02549937 ).
epNETs in China: On December 30, 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 progression-free survival (" PFS")
at a preplanned interim analysis. The positive results of this
trial were highlighted in an oral presentation at the 2019 ESMO
Congress and published in The Lancet Oncology in September 2020.
[12] 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: In 2016, we initiated the SANET-p study, which
is a pivotal Phase III study in patients with low- or
intermediate-grade, advanced pNET in China. It was terminated early
as the pre-defined primary endpoint of PFS was met
(clinicaltrials.gov identifier: NCT02589821 ) at a preplanned
interim analysis, leading to a second NDA accepted by the NMPA in
September 2020. The positive results of this study were presented
at the 2020 ESMO Virtual Congress and published simultaneously in
The Lancet Oncology ([13]) , demonstrating that surufatinib reduces
the risk of disease progression or death by 51% in patients, with
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.
Biliary tract cancer in China: In March 2019, we initiated a
Phase IIb/III study comparing surufatinib with capecitabine in
patients with advanced biliary tract cancer whose disease
progressed on first-line chemotherapy. The primary endpoint is
overall survival (OS) (clinicaltrials.gov identifier: NCT03873532
).
Immunotherapy combinations: We have 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.
About Tislelizumab
Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal
antibody specifically designed to minimize binding to
Fc<GAMMA>R on macrophages. In pre-clinical studies, binding
to Fc<GAMMA>R on macrophages has been shown to compromise the
anti-tumor activity of PD-1 antibodies through activation of
antibody-dependent macrophage-mediated killing of T effector cells.
Tislelizumab is the first drug from BeiGene's immuno-oncology
biologics program and is being developed internationally as a
monotherapy and in combination with other therapies for the
treatment of a broad array of both solid tumor and hematologic
cancers.
The NMPA has granted tislelizumab full approval for first-line
treatment of patients with advanced squamous non-small cell lung
cancer (NSCLC) in combination with chemotherapy. Tislelizumab has
also received conditional approval from the NMPA for the treatment
of patients with classical Hodgkin's lymphoma (cHL) who received at
least two prior therapies, and for the treatment of patients with
locally advanced or metastatic urothelial carcinoma (UC) with PD-L1
high expression whose disease progressed during or following
platinum-containing chemotherapy or within 12 months of neoadjuvant
or adjuvant treatment with platinum-containing chemotherapy. Full
approval for these indications is contingent upon results from
ongoing randomized, controlled confirmatory clinical trials.
In addition, three supplemental Biologics License Applications
for tislelizumab have been accepted by the Center for Drug
Evaluation (CDE) of the NMPA and are under review for first-line
treatment of patients with advanced non-squamous NSCLC in
combination with chemotherapy, for the second- or third-line
treatment of patients with locally advanced or metastatic NSCLC who
progressed on prior platinum-based chemotherapy, and for previously
treated unresectable hepatocellular carcinoma.
Currently, 15 potentially registration-enabling clinical trials
are being conducted in China and globally, including 12 Phase 3
trials and two pivotal Phase 2 trials.
In January 2021, BeiGene and Novartis entered into a
collaboration and license agreement to develop, manufacture, and
commercialize tislelizumab in North America, Europe, and Japan.
Tislelizumab is not approved for use outside of China.
About HUTCHMED
HUTCHMED (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
biopharmaceutical company committed, over the past twenty years, to
the discovery and global development of targeted therapies and
immunotherapies for the treatment of cancer and immunological
diseases. It has advanced ten cancer drug candidates from discovery
into clinical studies around the world and has an extensive
commercial infrastructure in its home market of China. For more
information, please visit: www.hutch-med.com.
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 and other federal
securities laws, including statements regarding the clinical
development of surufatinib in combination with tislelizumab,
HUTCHMED's and BeiGene's roles and responsibilities in the
collaboration, the opportunity and potential benefits of their
product candidates both as monotherapies and in combination, and
other information that is not historical information. Actual
results may differ materially from those indicated in the
forward-looking statements as a result of various important
factors, including the ability of HUTCHMED and BeiGene to develop
and receive regulatory approvals for the combination therapies in
the collaboration; the risk that the potential benefits of the
collaboration do not materialize or do not outweigh the costs; the
ability of HUTCHMED and BeiGene to demonstrate the efficacy and
safety of their respective drug candidates as monotherapies or in
combination; the clinical results for such drug candidates, which
may not support further development or marketing approval; actions
of regulatory agencies, which may affect the initiation, timing and
progress of clinical trials and marketing approval; HUTCHMED's and
BeiGene's ability to achieve commercial success for their marketed
products and drug candidates, if approved; HUTCHMED's and BeiGene's
ability to obtain and maintain protection of intellectual property
for their respective technology and drugs; BeiGene's and HUTCHMED's
reliance on third parties to conduct drug development,
manufacturing and other services; BeiGene's limited experience in
obtaining regulatory approvals and commercializing pharmaceutical
products and BeiGene's and HUTCHMED's ability to obtain additional
funding for operations and to complete the development and
commercialization of their drug candidates; and the impact of the
COVID-19 pandemic on BeiGene's and HUTCHMED's clinical development,
regulatory, commercial and other operations. 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 or BeiGene's filings with the U.S. Securities and
Exchange Commission and, in the case of HUTCHMED, on AIM. All
information in this press release is as of the date of this press
release, and neither HUTCHMED nor BeiGene undertakes a duty to
update such information unless required by law.
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 - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile) / +852 97 83 6894 (Mobile)
HUTCHMED@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Globocan. All Cancers Fact Sheet. World Health Organization.
https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf.
[2] SEER. Cancer Stat Facts: Colorectal Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/colorect.html
.
[3] SEER. Cancer Stat Facts: Lung and Bronchus Cancer. National
Cancer Institute.
https://seer.cancer.gov/statfacts/html/lungb.html.
[4] Globocan Europe Fact Sheet. World Health Organization.
https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf.
[5] SEER*Explorer. Small Cell Carcinoma of the Lung and
Bronchus. National Cancer Institute.
https://seer.cancer.gov/explorer/application.html?site=611&data_type=1&graph_type=2&compareBy=sex&chk_sex_1=1&race=1&age_range=1&stage=101&hdn_rate_type=1&advopt_precision=1&advopt_display=1.
[6] SEER*Explorer. Small Cell Carcinoma of the Lung and
Bronchus. National Cancer Institute.
https://seer.cancer.gov/explorer/application.html?site=611&data_type=4&graph_type=5&compareBy=sex&chk_sex_1=1&series=9&race=1&age_range=1&stage=101&advopt_precision=1.
[7] SEER. Cancer Stat Facts: Stomach Cancer. National Cancer
Institute. https://seer.cancer.gov/statfacts/html/stomach.html.
[8] SEER. Cancer Stat Facts: Soft Tissue including Heart Cancer.
National Cancer Institute.
https://seer.cancer.gov/statfacts/html/soft.html.
[9] Nagar SP, Mytelka DS, Candrilli SD, et al. Treatment
Patterns and Survival among Adult Patients with Advanced Soft
Tissue Sarcoma: A Retrospective Medical Record Review in the United
Kingdom, Spain, Germany, and France. Sarcoma. 2018;2018:5467057.
Published 2018 May 24. doi:10.1155/2018/5467057.
[10] Surufatinib in advanced neuroendocrine tumors -
extra-pancreatic (non-pancreatic).
[11] Surufatinib in advanced neuroendocrine tumors -
pancreatic.
[12] 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 .
[13] 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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