TIDMHCM
Hutchison China Meditech Limited
25 September 2019
Press Release
Chi-Med Highlights Presentation of Clinical Data from the
Successful SANET-ep Phase III Trial at ESMO Annual Meeting
- Late-Breaking Abstract of the positive SANET-ep Phase III
trial of surufatinib in patients with non-pancreatic neuroendocrine
tumors ("NET") to be presented -
- Conference call and webcast with lead trial investigators to
be held on Monday, September 30 to review surufatinib data -
- Data from ongoing international clinical trials with
surufatinib and fruquintinib to be presented -
London: Wednesday, September 25, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) will showcase data from its
proprietary clinical programs at the 2019 European Society for
Medical Oncology Congress ("ESMO") on September 27 to October 1,
2019 in Barcelona, Spain.
A key highlight will be the oral presentation of a Late-Breaking
Abstract reporting efficacy and safety results from the positive
Phase III trial in China of surufatinib in non-pancreatic
neuroendocrine tumors ("NET"), known as SANET-ep. An interim
analysis in June 2019 confirmed that the study met its primary
endpoint of progression-free survival ("PFS"). As a result, the
independent data monitoring committee ("IDMC") recommended the
study be stopped, a year ahead of schedule, and preparations are
now underway for the submission of a New Drug Application ("NDA")
by the end of 2019 for this indication in China.
The Late-Breaking Abstract will be published on the ESMO website
coincident with the its presentation; the details of which are as
follows:
Title: Efficacy and Safety of Surufatinib in Patients with
Well-Differentiated Advanced Extrapancreatic Neuroendocrine
Tumors: Results from the Randomized Phase III Study
(SANET-ep)
Presenting Author: Jianming Xu, Head of the Department of Gastrointestinal
Oncology, The Fifth Medical Center, General Hospital
of the PLA
Abstract #: LBA76
Date & Time: Sunday, September 29, 2019, 16:30 CEST
Location: Tarragona Auditorium (Hall 7), Fira de Barcelona Gran
Via Conference Centre
A conference call and webcast for analysts and investors will be
held on Monday September 30, 1 p.m. U.K. time (2 p.m. Barcelona
time; 8 a.m. New York time; 8 p.m. Hong Kong time) to review the
SANET-ep trial data presented on Sunday, September 29. Safety and
tolerability data presented from an ongoing U.S. Phase Ib study of
surufatinib in pancreatic NET patients who have progressed on
Sutent(R) or Afinitor(R) treatment will also be discussed.
Participating in the call will be Dr. James Yao, Chair of GI
Oncology at MD Anderson Cancer Center and one of the lead
investigators for our ongoing Phase I/Ib surufatinib study in NET,
as well as members of the Chi-Med management team. Dial-in details
for the conference call will be available prior to the event at
www.chi-med.com/event-information, and a replay will also be
available shortly after.
Details of the abstract for the U.S. Phase Ib trial of
surufatinib in pancreatic NET patients are as follows:
Title: Safety and Tolerability of Surufatinib in Western Patients
with Solid Tumors
Presenting Author: Erika P. Hamilton, Director, Breast and Gynecologic
Cancer Research at Sarah Cannon Research Institute
Abstract # &
Link: 1393P
Date & Time: Sunday, September 29, 2019, 12:00 CEST
Location: Hall 4, Fira de Barcelona Gran Via Conference Centre
Other Clinical Data Abstracts
Fruquintinib in the U.S. and Europe: Safety and tolerability of
fruquintinib in Western patients with solid tumors will be
presented. Fruquintinib is currently in planning for a Phase III
registration study in the U.S. and Europe in metastatic colorectal
cancer ("CRC") patients who are resistant to or intolerant of prior
treatment with Stivarga(R) or Lonsurf(R) . In China, fruquintinib
is currently sold under the brand name Elunate(R) , and is for the
treatment of patients with metastatic CRC that have been previously
treated with fluoropyrimidine, oxaliplatin and irinotecan,
including those who have previously received anti-VEGF therapy
and/or anti-EGFR therapy (RAS wild type).
Title: Phase 1 Trial of Fruquintinib in Patients with Advanced
Solid Tumors: Results of the Dose Escalation Phase
Presenting Author: Andrea Wang-Gillam, Associate Professor of Medicine,
Division of Oncology, Section of Medical Oncology,
Washington University School of Medicine
Abstract #: 467P
Date & Time: Saturday, September 28, 2019, 12:00 CEST
Location: Hall 4, Fira de Barcelona Gran Via Conference Centre
Chi-Med retains all rights to surufatinib worldwide. It retains
all rights to fruquintinib outside of China and is partnered with
Eli Lilly and Company in China.
Trials-in-Progress Abstracts
Title: A Phase 1 Study of HMPL-523, a Selective Oral Anti-Spleen
Tyrosine Kinase Inhibitor, in Patients with Relapsed
or Refractory Lymphoma
Lead Author: Nathan Fowler, Associate Professor, Department of Lymphoma/Myeloma,
the University of Texas MD Anderson Cancer Center
Abstract #: 1106TiP
Date & Time: Saturday, September 28, 2019, 12:00 CEST
Location: Hall 4, Fira de Barcelona Gran Via Conference Centre
Title: A Phase 1 Study of HMPL-689, a Selective Oral Phosphoinositide
3-Kinase-Delta Inhibitor, in Patients with Relapsed
or Refractory Lymphoma
Lead Author: Jonathan B. Cohen, Associate Professor, Department
of Hematology and Medical Oncology, Emory University
School of Medicine
Abstract #: 1107TiP
Date & Time: Saturday, September 28, 2019, 12:00 CEST
Location: Hall 4, Fira de Barcelona Gran Via Conference Centre
About SANET-ep
SANET-ep is a randomized, double-blind, placebo-controlled,
multi-center, Phase III study of surufatinib in advanced
neuroendocrine tumors - extra-pancreatic patients in China for whom
there is no effective therapy. In June 2019, an interim analysis
was conducted, leading to the IDMC determination that the study met
the pre-defined primary endpoint of PFS and should be stopped
early. Preparations for an NDA submission are now underway for this
indication in China. In this study, patients with low- or
intermediate-grade advanced extra-pancreatic neuroendocrine tumors
for whom there is no effective therapy are randomized at a 2:1
ratio to receive either 300 mg of surufatinib orally daily or
placebo, on a 28-day treatment cycle. The primary endpoint of the
study is to evaluate the PFS, with secondary endpoints including
objective response rate (ORR), disease control rate (DCR), time to
response (TTR), duration of response (DoR), overall survival (OS),
safety, and tolerability. Additional details may be found at
clinicaltrials.gov, using identifier NCT02588170.
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 and fruquintinib, plans to initiate clinical studies
for surufatinib and fruquintinib, 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 drug candidates surufatinib and fruquintinib, including
as a 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 and
fruquintinib 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
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