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Hutchison China Meditech Limited
13 February 2018
Press Release
Chi-Med Completes Enrollment of 527 Patients in Pivotal Phase
III FALUCA Trial with Fruquintinib in Lung Cancer
London: Tuesday, February 13, 2018: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) has completed patient
enrollment of FALUCA, its Phase III pivotal trial of fruquintinib
in advanced, third-line, non-small cell lung cancer ("NSCLC")
patients in China. Fruquintinib is a highly selective and potent
oral inhibitor of vascular endothelial growth factor receptors
("VEGFR") 1, 2 and 3, that has met its primary endpoint in several
Phase II and III clinical trials in China for the treatment of
lung, colorectal and gastric cancers. Top-line FALUCA data is
expected to be reported in late 2018 when the overall survival
("OS") data is mature and, subject to a positive outcome, would be
followed by a second New Drug Application ("NDA") submission
thereafter. Fruquintinib's first NDA, for the treatment of
colorectal cancer, was submitted to the China Food and Drug
Administration ("CFDA") in June 2017.
About Fruquintinib
Fruquintinib (HMPL-013) is a highly selective small molecule
drug candidate that has been shown to inhibit VEGFR 24 hours a day
via an oral dose, with lower off-target toxicities compared to
other targeted therapies. Its tolerability, along with its clean
drug-drug interaction profile demonstrated to date, may enable
rational combination with other cancer therapies such as in our
ongoing clinical trials of fruquintinib in combination with
chemotherapy and targeted therapy. VEGFR plays a pivotal role in
tumor-related angiogenesis.
About FALUCA
FALUCA is a randomized, double-blind, placebo-controlled,
multi-center, Phase III registration study of fruquintinib targeted
at treating patients with advanced non-squamous NSCLC, who have
failed two lines of systemic chemotherapy. Patients were randomised
at a 2:1 ratio to receive either 5mg of fruquintinib orally once
per day, on a three-weeks-on / one-week-off cycle, plus best
supportive care ("BSC"); or placebo plus BSC. Randomization was
stratified by EGFR gene status and history of treatment by VEGF
inhibitors. The primary endpoint is OS, with secondary endpoints
including progression free survival ("PFS"), objective response
rate (ORR), disease control rate (DCR) and duration of response
(DoR). Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT02691299.
It was initiated following a similar Phase II clinical trial in
91 third-line NSCLC patients that succeeded in meeting its primary
efficacy endpoint of PFS, with no unexpected safety issues. Results
were highlighted in an oral presentation at the 17(th) World
Conference on Lung Cancer on December 6, 2016 (clinicaltrials.gov
identifier NCT02590965).
Other Fruquintinib Development Programs
Lung cancer in China: Along with FALUCA, fruquintinib is
concurrently being studied in a Phase II study in combination with
Iressa(R) (gefitinib) in first-line setting for patients with
advanced or metastatic NSCLC (clinicaltrials.gov identifier
NCT02976116). Preliminary results were highlighted in an oral
presentation at the 18(th) World Conference on Lung Cancer on
October 16, 2017.
Colorectal cancer in China: The CFDA acknowledged acceptance of
the NDA for fruquintinib for the treatment of patients with
advanced colorectal cancer ("CRC") in June 2017. Fruquintinib was
subsequently awarded priority review status in view of its
significant clinical value, according to a CFDA announcement in
September 2017. The NDA is supported by data from the successful
FRESCO study, a Phase III pivotal registration trial of
fruquintinib in 416 patients with CRC in China, which was
highlighted in an oral presentation at the American Society of
Clinical Oncology Annual Meeting held on June 5, 2017
(clinicaltrials.gov identifier NCT02314819). The FRESCO study
followed an initial Phase I trial in 40 solid tumor patients, a
Phase Ib study in 62 CRC patients, and a Phase II clinical trial in
71 CRC patients.
Gastric cancer in China: In October 2017, Chi-Med initiated a
pivotal Phase III clinical trial of fruquintinib in combination
with Taxol(R) (paclitaxel), known as the FRUTIGA study, for the
treatment of over 500 patients with advanced gastric or
gastroesophageal junction (GEJ) adenocarcinoma who have progressed
after first-line standard chemotherapy (clinicaltrials.gov
identifier NCT03223376). The FRUTIGA study followed a Phase I/II
clinical trial in 34 patients that demonstrated that combination
therapy of fruquintinib and Taxol(R) in such patients was generally
well-tolerated with promising tumor response (clinicaltrials.gov
identifier NCT02415023).
In China, fruquintinib is jointly developed with Eli Lilly and
Company.
United States bridging trial: In December 2017, Chi-Med
initiated a multi-center, open-label, Phase I clinical study to
evaluate the safety, tolerability and pharmacokinetics of
fruquintinib in U.S. patients with advanced solid tumors.
Additional details about this study may be found at
clinicaltrials.gov, using identifier NCT03251378.
About Chi--Med
Chi--Med is an innovative biopharmaceutical company which
researches, develops, manufactures and sells pharmaceuticals and
healthcare products. Its Innovation Platform, Hutchison MediPharma
Limited, focuses on discovering and developing innovative
therapeutics in oncology and autoimmune diseases for the global
market. Its Commercial Platform manufactures, markets, and
distributes prescription drugs and consumer health products in
China.
Chi--Med is 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
fruquintinib, plans to initiate clinical studies for 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
candidate fruquintinib 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 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, Corporate Finance
& Development +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
Brad Miles, BMC Communications +1 (917) 570 7340 (Mobile) bmiles@bmccommunications.com
Susan Duffy, BMC Communications +1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group +1 (917) 415 1750 (Mobile) mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile) david.dible@citigatedewerogerson.com
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
This information is provided by RNS
The company news service from the London Stock Exchange
END
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