Hutchison China Meditech Limited Savolitinib PRCC Data to be presented at ASCO GU
12 Février 2019 - 8:00AM
RNS Non-Regulatory
TIDMHCM
Hutchison China Meditech Limited
12 February 2019
Press Release
Chi-Med Highlights Preliminary Phase II Savolitinib / Imfinzi(R)
Combination Data in Advanced Papillary Renal Cell Carcinoma at 2019
ASCO Genitourinary Cancers Symposium
London: Tuesday, February 12, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announced the
availability of preliminary results from the Phase II CALYPSO study
of the savolitinib / Imfinzi(R) (durvalumab) combination in a
cohort of patients with metastatic papillary renal cell carcinoma
("PRCC"), an investigator initiated study led by Professor Thomas
Powles, Lead for Solid Tumour Research at Barts Cancer Institute,
and sponsored by Queen Mary University of London.
Full data from the PRCC cohort of the CALYPSO study will be
presented on Saturday, February 16, 2019, in oral and poster
presentations at the annual American Society of Clinical Oncology
Genitourinary Cancers Symposium ("ASCO GU") in San Francisco,
CA.
Further details from the presentation are as follows:
Presentation Title: A phase II study investigating the safety and efficacy of savolitinib and durvalumab in
metastatic
papillary renal cancer (CALYPSO)
First Author: Thomas Powles, MD, PhD, FCRP
Abstract No: 545
Oral Presentation: Oral Abstract Session C: Renal Cell Cancer
Date & Time: Saturday, February 16: 2:00 PM-3:30 PM PST
Poster Presentation: Session C: Renal Cell Cancer
Date & Time: Saturday, February 16: 7:00 AM-7:55 AM and 12:30 PM-2:00 PM PST
About PRCC in the CALYPSO study
PRCC is a subtype of kidney cancer that is unusually difficult
to treat, with low response rates from current treatment options
and no treatments approved for this specific indication. The
CALYPSO study is an independently sponsored open-label Phase II
study of Imfinzi(R) in combination with several drug candidates in
the treatment of renal cell carcinoma in the U.K. and Spain.
Several arms of CALYPSO are evaluating the treatment of PRCC and
clear cell renal carcinoma (ccRCC) with savolitinib, a highly
selective inhibitor of the c-MET receptor tyrosine kinase, both as
a monotherapy and in combination with Imfinzi(R) (durvalumab),
AstraZeneca's anti-programmed death-ligand 1 ("PD-L1") antibody.
CALYPSO enrolls an all-comer PRCC population with planned
retrospective molecular profiling. For further details, please
refer to clinicaltrials.gov number NCT02819596.
About Savolitinib
Savolitinib is a potential first-in-class inhibitor of c-MET, an
enzyme which has been shown to function abnormally in many types of
solid tumors. Chi-Med designed savolitinib to be a potent and
highly selective oral inhibitor, which, through chemical structure
modification, addresses human metabolite-related renal toxicity,
the primary issue that halted development of several other
selective c-MET inhibitors. In clinical studies to date, involving
over 700 patients, savolitinib has shown promising signs of
clinical efficacy in patients with c-MET gene alterations in PRCC,
NSCLC, colorectal cancer (CRC) and gastric cancer with an
acceptable safety profile. Chi-Med is currently testing savolitinib
in partnership with AstraZeneca in Phase Ib/II studies, in multiple
solid tumor indications, both as a monotherapy and in
combinations.
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 400 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
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.
Dual-listed on the AIM market of the London Stock Exchange and
the Nasdaq Global Select Market, Chi-Med is headquartered in Hong
Kong and majority owned by the multinational conglomerate CK
Hutchison Holdings Limited (SEHK: 1). 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
savolitinib, plans to initiate clinical studies for savolitinib,
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
candidate savolitinib to meet the primary or secondary endpoint of
a study, to obtain regulatory approval in different jurisdictions
and to gain commercial acceptance after obtaining regulatory
approval, the potential market of savolitinib for a targeted
indication and the sufficiency of funding. In addition, as certain
studies rely on the use of Imfinzi(R) as combination therapeutics
with savolitinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of Imfinzi(R) . 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
Richard Gray / Andrew Potts, Panmure Gordon (UK) Limited +44 (20) 7886 2500
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END
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