TIDMHCM
Hutchison China Meditech Limited
30 September 2019
Press Release
Chi-Med to Discuss Surufatinib Phase III and U.S. Phase I/Ib
Efficacy and Safety Data Presented at the 2019 ESMO Annual
Meeting
- Surufatinib achieved primary endpoint, reducing the risk of
progression or death by 67% in patients with non-pancreatic
neuroendocrine tumors ("NET") in the Phase III SANET-ep study -
- Preparations underway for the potential submission of
surufatinib New Drug Application ("NDA") by year end 2019 for
non-pancreatic NET tumors in China -
- Treatment options are limited for the 90% of all global NET
patients whose tumors originate outside of the pancreas.
Surufatinib represents an important potential advancement for these
patients -
- Conference call and webcast to be held on Monday, September
30, 2 p.m. Barcelona time to review surufatinib data -
London: Sunday, September 29, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today presented the results
of the Phase III study of surufatinib in advanced neuroendocrine
tumors - extra-pancreatic (SANET-ep) at the 2019 European Society
for Medical Oncology Congress ("ESMO"). The study has met the
pre-defined primary endpoint of progression free survival ("PFS")
early. Patients treated with surufatinib were 67% less likely to
see their disease progress or die as compared to patients on
placebo control, assessed by local investigators.
Chi-Med is holding an investor conference call and webcast on
Monday, September 30, to review the SANET-ep data. In addition,
safety and tolerability data presented from an ongoing U.S. Phase
Ib study of surufatinib in pancreatic NET patients who are
refractory to Sutent(R) and Afinitor(R) will also be discussed.
SANET-ep - Phase III study in patients with extra-pancreatic
(non-pancreatic) NET in China:
As announced in June 2019, the independent Data Monitoring
Committee ("IDMC") for the trial recommended that the study stop
early because it had met the pre-defined primary endpoint of PFS
during a planned interim analysis. Preparations are now underway
for the potential NDA submission by year end 2019 for this
indication in China.
At data cut-off as of March 31, 2019, 198 patients were
randomized 2:1 to treatment with either 300 mg of surufatinib
orally daily (N=129) or placebo control (N=69), on a 28-day cycle.
Median PFS per investigator assessment was 9.2 months for patients
treated with surufatinib, as compared to 3.8 months for patients in
the placebo group (hazard ratio ["HR"] 0.334; 95% confidence
interval ["CI"] 0.223-0.499; p<0.0001).
The efficacy of surufatinib was seen across all subgroups, and
supported by statistically significant improvement as measured by
secondary efficacy endpoints including objective response rate
("ORR"), disease control rate ("DCR"), time to response ("TTR"),
duration of response ("DoR"), safety, and tolerability. Efficacy
was also supported by Blinded Independent Image Review Committee
("BIIRC") assessment. Overall survival ("OS") data was not mature,
with only 18.7% OS events at data cut-off. Surufatinib was
generally well-tolerated in this study and the safety profile is
consistent with observations in prior clinical studies.
Dr. Jianming Xu, co-lead investigator for the SANET-ep study,
Head of the Department of Gastrointestinal Oncology, The Fifth
Medical Center, General Hospital of the People's Liberation Army in
Beijing, said: "The SANET-ep results showed that surufatinib
meaningfully benefited Chinese patients with progressive, advanced
extra-pancreatic NET, across multiple measures of efficacy and was
generally well tolerated. Importantly, these positive results were
achieved in patients regardless of tumor origin and in patients who
received prior systematic treatment for their disease."
Dr. Lin Shen, co-lead investigator for the SANET-ep study, Vice
President of the Beijing Cancer Hospital and Head of its Department
of Gastroenterological Oncology, said: "NET is a disease that many
oncologists encounter in their practices. Both in China and
globally, options are limited for NET patients whose tumors
originate outside of the pancreas. These patients account for over
90% of all NET cases. The SANET-ep results represent an important
potential advancement in clinical practice for these patients."
Summary of key efficacy results:
Surufatinib Placebo Hazard Ratio (95% CI),
(n=129) (n=69) p-value
----------- ---------- -------------------------
Primary endpoint:
PFS (investigator assessment) 9.2 months 3.8 months 0.334 (0.223-0.499),
p<0.0001
------------------------------- ----------- ---------- -------------------------
Secondary endpoints:
ORR 10.3% 0% (5.6%-17.0%), p=0.0051
Odds Ratio 3.3 (1.5-7.3),
DCR 86.5% 65.6% p=0.0022
TTR 3.7 months (1.8, 5.5)
DoR 5.6 months (2.0, 17.5)
------------------------------- ----------- ---------- -------------------------
Investor Audio Webcast and Conference Call Scheduled on Monday
at 2 p.m. Barcelona Time (1 p.m. London time, 8 a.m. New York time,
8 p.m. Hong Kong time):
Participating on the webcast will be members of the Chi-Med
management team as well as Dr. James Yao, Chair of Gastrointestinal
Oncology at MD Anderson Cancer Center and one of the lead
investigators for Chi-Med's ongoing Phase I/Ib surufatinib study in
NET. Toll-free dial-in numbers are as follows: U.K. 0808 109 0700;
U.S. 1 866 966 5335; Mainland China 4001 200558; and Hong Kong 800
900 476.
Presentation slides will be posted before the call begins.
Additional numbers and the slides will be available at
www.chi-med.com/event-information/, and a replay will also be
available shortly after the event.
Additional details from the SANET-ep study presentation
include:
-- Patient Characteristics: 83.8% of the patients in the study
had disease with pathological grade 2. 41.4% of patients had
disease originating outside of the gastrointestinal (GI) tract and
the lung or with unknown origin. 67.2% of patients received prior
systematic anti-tumor treatment for their disease, including
chemotherapy (39.9%), somatostatin analogue (31.8%), and everolimus
(9.1%). More patients in the surufatinib group received prior
loco-regional therapy (34.1%) relative to the placebo group
(23.3%). These therapies, such as chemoembolization, radiofrequency
ablation of the surrounding organs may lead to challenges in
evaluating lesions in those organs. A higher proportion of patients
in the placebo group had Eastern Cooperation Oncology Group (ECOG)
performance score of 0 (66.7%) than in the surufatinib group
(55.8%).
-- Subgroup analyses: PFS improvement was seen in multiple
pre-specified subgroups, regardless of site of primary tumor
(gastrointestinal or other), whether patients received prior
systematic treatment for their disease, and irrespective of their
baseline ECOG performance status.
-- Safety profile is consistent with previous reports and
surufatinib is generally well-tolerated. The most common Grade
>=3 adverse events ("AEs") among surufatinib treated patients
were hypertension (36.4% vs. 13.2%) and proteinuria (19.4% vs. 0%).
Any Grade >=3 AEs occurred in 76.6% of patients who received
surufatinib compared to 33.8% of patients who received placebo, and
17.8% of surufatinib patients had an AE leading to discontinuation
of treatment compared to 5.9% in the placebo group.
-- BIIRC Assessment: A BIIRC performed tumor assessment
retrospectively in parallel, which was used for supportive
sensitivity analysis of PFS. BIIRC median PFS was not a primary or
secondary endpoint of the study. Median PFS per pre-specified BIIRC
was 7.4 months for patients treated with surufatinib, as compared
to 3.9 months for patients in the placebo group (HR 0.657;
0.442-0.977; p=0.0372). As differences between investigator and
BIIRC reviews are often observed in global NET studies, post-hoc
blinded image adjudication by independent reviewers, who are
particularly experienced with evaluating NET patients, was
conducted for the 35 patients with PFS discrepancy >= 4 cycles
between BIIRC and investigator assessment. Per the post-hoc blinded
image adjudication, median BIIRC PFS was unchanged, although the
hazard ratio was 0.570 (CI 0.381-0.852), with p-value of
0.0065.
Additional details may be found at clinicaltrials.gov, using
identifier NCT02588170. A copy of the presentation will be
available at www.chi-med.com.
Surufatinib Phase I/Ib study in the US
Safety and tolerability data of surufatinib in western patients
were presented at ESMO 2019 as a poster on Sunday, September 29,
including data on 15 patients (12 efficacy evaluable) with heavily
treated pancreatic NET. The study confirmed 300mg as the
recommended Phase 2 dose (RP2D), the same as that used in the China
studies. Preliminary data shows promising anti-tumor activity in
the pancreatic NET patients, with ORR of 13.3% and DCR of 73.3%.
Additional details may be found at clinicaltrials.gov, using
identifier NCT02549937.
About Neuroendocrine Tumors
Neuroendocrine tumors 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. Neuroendocrine tumors are
typically classified as pancreatic neuroendocrine tumors or other
neuroendocrine tumors. Approved targeted therapies include
Sutent(R) and Afinitor(R) for pancreatic neuroendocrine tumors, or
well-differentiated, non-functional gastrointestinal or lung
neuroendocrine tumors.
According to Frost and Sullivan, there were 19,000 newly
diagnosed cases of neuroendocrine tumors in the U.S. in 2018.
Importantly, neuroendocrine tumors 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
neuroendocrine tumors in the U.S. in 2018 of which over 90%, or
approximately 132,000, were non-pancreatic neuroendocrine tumor
patients.
In China there were approximately 67,600 newly diagnosed
neuroendocrine patients in 2018 and, considering the U.S. incidence
to prevalence ratio, potentially as many as 300,000 patients living
with the disease.
About Surufatinib
Discovered and developed solely by Chi-Med, surufatinib
(previously known as HMPL-012 or sulfatinib) is a novel, oral drug
candidate 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, as well as colony stimulating factor-1 receptor
(CSF-1R), which regulates tumor-associated macrophages, promoting
the body's immune response against tumor cells. Surufatinib's
unique dual mechanism of action may be very suitable for possible
combinations with other immunotherapies. Surufatinib is in
proof-of-concept clinical trials in the U.S. and several
proof-of-concept and late-stage clinical trials in China, for
indications such as neuroendocrine tumors and biliary tract
cancer.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 440 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies in oncology and autoimmune diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world. Chi-Med's Commercial Platform
manufactures, markets, and distributes prescription drugs and
consumer health products, covering an extensive network of
hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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 for the clinical development of
surufatinib, plans to initiate clinical studies for surufatinib,
its expectations as to whether such studies 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, 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 in combination therapies, to meet the
primary or secondary endpoint of a study, to obtain regulatory
approval in different jurisdictions, to gain commercial acceptance
after obtaining regulatory approval, the potential market of
surufatinib for a targeted indication and the sufficiency of
funding. 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
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
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END
NRASEISAUFUSESU
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