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Hutchison China Meditech Limited
10 February 2020
Press Release
Chi-Med Highlights Updated Phase II Savolitinib / Imfinzi(R)
Combination Data in Advanced Papillary Renal Cell Carcinoma at 2020
ASCO Genitourinary Cancers Symposium
London: Monday, February 10, 2020: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announced the
availability of updated 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 15, 2020, 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: Overall survival results for durvalumab and savolitinib in metastatic papillary renal cancer
Presenting Author: Cristina Suarez Rodriguez, MD, Hospital Univ. Vall D Hebron General, Barcelona, Spain
Other Authors: Thomas Powles, James M. G. Larkin, Poulam Patel, Begoña Pérez-Valderrama, Alejo
Rodriguez-Vida, Hilary Glen, Fiona Thistlethwaite, Christy Ralph, Srinivasan Gopalakrishnan,
Maria Jose Mendez-Vidal, Kelly Mousa, Aaron Prendergast, Laura Vosper, Wing-Kin Liu
Abstract #: 619 / Board D5
Oral Presentation: Rapid Abstract Session C: Renal Cell Cancer
Date & Time: Saturday, February 15: 10:00 AM-11:30 AM PST
Poster Presentation: Session C: Renal Cell Cancer
Date & Time: Saturday, February 16: 7:00 AM-7:55 AM and 12:30 AM-2:00 PM PST
Preliminary results of this study (cut-off date of September 25,
2018) were first presented on February 16, 2019 at ASCO-GU.[1]
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 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 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 MET inhibitors. In clinical studies to date, involving
over 1,000 patients, savolitinib has shown promising signs of
clinical efficacy in patients with MET gene alterations in multiple
tumor types with an acceptable safety profile. Chi-Med is currently
testing savolitinib in global partnership with AstraZeneca, both as
a monotherapy and in combination with immunotherapy, targeted
therapy and chemotherapy drugs.
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 500 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies for the treatment of cancer 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
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, 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 savolitinib 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
[1] Powles,et al. A phase II study investigating the safety and
efficacy of savolitinib and durvalumab in metastatic papillary
renal cancer (CALYPSO). 2019 American Society of Clinical Oncology
Genitourinary Cancers Symposium Abstract #545. Presented on
February 16, 2019.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
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END
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