TIDMHCM
Hutchison China Meditech Limited
21 September 2020
Press Release
Chi-Med Highlights Surufatinib Phase III Results in
Neuroendocrine Tumors at ESMO 2020 and Publications in The Lancet
Oncology
_ Phase III SANET-p demonstrated surufatinib reduces the risk of
disease progression or death by 51% in patients with pancreatic
neuroendocrine tumors ("NET") _
_ SANET-p results complement previously presented positive Phase
III SANET-ep results in patients with non-pancreatic NET, including
across multiple subgroups _
_ Results of both SANET-p and SANET-ep studies published in The
Lancet Oncology -
Hong Kong, Shanghai, & Florham Park, NJ: Monday, September
21, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that positive results of the Phase III study
of surufatinib in advanced neuroendocrine tumors - pancreatic
("SANET-p") were presented as a proffered paper session at the
European Society for Medical Oncology ("ESMO") Virtual Congress
2020 (Abstract Number 1156O). Results from SANET-p, in addition to
previously presented results from Phase III study of surufatinib in
advanced neuroendocrine tumors - extra-pancreatic ("SANET-ep"), are
published today in The Lancet Oncology.
"Surufatinib demonstrated statistically significant and
clinically meaningful benefits in patients with advanced pancreatic
NET. These results, combined with positive results from the
parallel study of surufatinib in patients with non-pancreatic NET,
support surufatinib as a promising treatment option for
well-differentiated NET patients regardless of tumor origin,"
commented Dr. Jianming Xu, lead investigator for the SANET-p study,
Head of the Department of Gastrointestinal Oncology, The Fifth
Medical Center, General Hospital of the PLA in Beijing.
As announced in January 2020, the Independent Data Monitoring
Committee ("IDMC") for the SANET-p trial recommended that the study
stop early because it had met the pre-defined primary endpoint of
progression free survival ("PFS") during a planned interim
analysis. At data cut-off as of November 11, 2019, 172 patients
were randomized 2:1 to treatment with either 300 mg of surufatinib
orally daily (N=113) or placebo control (N=59), on a 28-day cycle.
Median PFS was 10.9 months for patients treated with surufatinib,
as compared to 3.7 months for patients in the placebo group (hazard
ratio ["HR"] 0.491; 95% confidence interval ["CI"] 0.391-0.755; p
=0.0011). Benefit was observed across most major subgroups of pNET
patients. Objective response rates (ORR) were 19.2%[1] for the 104
efficacy evaluable patients in the surufatinib group versus 1.9%[2]
for the 53 efficacy evaluable patients in the placebo group, with a
disease control rate (DCR) of 80.8% versus 66.0%, respectively.
Most patients in the trial had Grade 2 disease with heavy tumor
burden, including liver metastasis and multiple organ involvement.
Efficacy was also supported by Blinded Independent Image Review
Committee (BIIRC) assessment, with a median PFS of 13.9 months for
surufatinib as compared to 4.6 months for placebo (HR 0.339; 95% CI
0.209-0.549; p <0.0001).
The safety profile of surufatinib was manageable and consistent
with observations in prior studies. Treatment was well tolerated
for most patients, with discontinuation rates as a result of
treatment emergent adverse events of 10.6% in the surufatinib group
as compared to 6.8% in the placebo group.
In the U.S., the Food and Drug Administration ("FDA") granted
surufatinib two Fast Track Designations, for both the
non-pancreatic NET and pancreatic NET development programs, and
Orphan Drug Designation for pancreatic NET development. A rolling
new drug application ("NDA") submission is being prepared, to be
followed by a marketing authorization application ("MAA")
submission to the European Medicines Agency ("EMA") in Europe,
based on the robust data from the two studies and the ongoing
multi-cohort Phase Ib study in the U.S. In December 2019, an NDA
for surufatinib for the treatment of patients with advanced
non-pancreatic NET was granted Priority Review status by the China
National Medical Products Administration ("NMPA"). A second NDA for
surufatinib for the treatment of patients with advanced pancreatic
NET has also been accepted by the NMPA.
About NET
NET 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. NET are typically classified as pancreatic NET or
non-pancreatic NET. Approved targeted therapies include Sutent(R)
and Afinitor(R) for pancreatic NET, or well-differentiated,
non-functional gastrointestinal or lung NET.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of NET in the U.S. in 2018. Importantly, NET 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 NET in the U.S. in 2018.
In China, there were approximately 67,600 newly diagnosed NET
patients in 2018 and, considering the current incidence to
prevalence ratio in China, potentially as many as 300,000 patients
living with the disease in the country. [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 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.
Chi-Med currently retains all rights to surufatinib
worldwide.
About Surufatinib Development
NET in the U.S. and Europe: In the U.S., surufatinib was granted
Fast Track Designations for development in pancreatic and
non-pancreatic (extra-pancreatic) NET in April 2020, and Orphan
Drug Designation for pancreatic NET in November 2019. A U.S. FDA
NDA submission is being prepared, to be followed by a MAA
submission to the EMA in Europe. The basis to support these filings
includes the completed SANET-ep and SANET-p studies, along with
existing data from surufatinib in U.S. non-pancreatic and
pancreatic NET patients (clinicaltrials.gov identifier:
NCT02549937).
Non-pancreatic NET in China: In November 2019 , a NDA for
surufatinib for the treatment of patients with advanced
non-pancreatic NET was accepted for review by the NMPA and granted
Priority Review status in December 2019. The NDA is supported by
data from the successful SANET-ep study, a Phase III study of
surufatinib in patients with advanced non -pancreatic NET in China
for whom there is no effective therapy. A 198-patient interim
analysis was conducted in June 2019, leading the IDMC to determine
that the study met the pre-defined primary endpoint of PFS and
should be stopped early. The positive results of this trial were
highlighted in an oral presentation at the 2019 ESMO Congress
(clinicaltrials.gov identifier: NCT02588170) and published in The
Lancet Oncology in September 2020. [4] Median PFS was 9.2 months
for patients treated with surufatinib, as compared to 3.8 months
for patients in the placebo group (HR 0.334; 95% CI: 0.223-0.499; p
<0.0001).
Pancreatic NET 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 pancreatic NET in China. Following an
interim analysis review conducted in January 2020 by the IDMC that
recommended the registrational study be terminated early as the
pre-defined primary endpoint of PFS had already been met
(clinicaltrials.gov identifier: NCT02589821), leading to a second
NDA accepted by the China NMPA. The results of this study were
presented at the ESMO Virtual Congress 2020 and published
simultaneously in The Lancet Oncology. [5]
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, developed by BeiGene, Ltd.),
Tuoyi (R) (toripalimab, developed by Shanghai Junshi Biosciences
Co. Ltd.) and Tyvyt (R) (sintilimab, developed by Innovent
Biologics, Inc.), which are approved in China.
About Chi-Med
Chi-Med (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 a portfolio of nine cancer drug candidates
currently in clinical studies around the world and extensive
commercial infrastructure in its home market of China. For more
information, please visit: www.chi-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. These forward-looking
statements reflect Chi-Med's current expectations regarding future
events, including its expectations regarding the submission of an
NDA for surufatinib for the treatment of NET in the U.S., China and
other jurisdictions, the therapeutic potential of surufatinib for
the treatment of patients with NET, the further clinical
development for surufatinib in this and other indications, 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 the sufficiency of the clinical
data to support NDA approval of surufatinib for the treatment of
patients with NET in the U.S. and China or other jurisdictions, its
potential to gain expeditious approvals from regulatory
authorities, the safety profile of surufatinib, enrollment rates,
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, its 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 Chi-Med's filings with the
U.S. Securities and Exchange Commission and on AIM. Chi-Med
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)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Responses in the surufatinib group included 13 confirmed
partial responses and 7 unconfirmed partial responses.
[2] There was 1 confirmed partial response in the placebo
group.
[3] According to Frost & Sullivan, in 2018, there were
19,000 newly diagnosed cases of NETs in the U.S and an estimated
141,000 patients living with NETs. The current incidence to
prevalence ratio in China is estimated at 4.4, lower than the 7.4
ratio in the U.S. due to lower access to treatment options.
[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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