TIDMHCM
Hutchison China Meditech Limited
16 January 2017
Press Release
Chi-Med Initiates a Phase II Combination Study of Fruquintinib
with Iressa(R) (gefitinib) in First-Line Non-Small Cell Lung
Cancer
London: Monday, January 16, 2017: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) today announces that it has
initiated a Phase II study of a combination therapy using
fruquintinib and Iressa(R) in the first-line setting for patients
with advanced or metastatic non-small cell lung cancer ("NSCLC") in
China. Fruquintinib is a highly selective and potent oral inhibitor
of vascular endothelial growth factor receptors ("VEGFR"). The
first drug dose was administered on January 9, 2017.
This Phase II combination therapy study is a multi-center,
single-arm, open-label study. The objectives are to evaluate the
safety and tolerability as well as preliminary efficacy of the
combination therapy in the first-line setting for advanced or
metastatic non-squamous NSCLC patients with epidermal growth factor
receptor ("EGFR") activating mutations. Treatment will be continued
until disease progression or intolerable toxicity occurs.
Additional details about this study may be found at
clinicaltrials.gov, using identifier NCT02976116.
About NSCLC and Tyrosine Kinase Inhibitors ("TKIs") to address
EGFR-driven NSCLC
At an advanced stage, tumors secrete large amounts of vascular
endothelial growth factors ("VEGF"), which are protein ligandsthat
stimulate formation of excessive vasculature (angiogenesis) around
the tumor in order to provide greater blood flow, oxygen, and
nutrients to the tumor. VEGF and VEGFR play a pivotal role in
tumor-related angiogenesis. Inhibition of the VEGF/VEGFR pathway
represents an important therapeutic strategy in blocking the
development of new blood vessels essential for tumors to grow and
invade.
Every year, it is estimated that approximately 1.7 million new
patients around the world are diagnosed with NSCLC, according to
Frost & Sullivan. Lung cancer is the leading cause of cancer
death among both men and women, accounting for about one-quarter of
all cancer deaths (American Cancer Society), and more than breast,
prostate and colorectal cancers combined.
NSCLC patients with EGFR activating mutations, which are an
estimated 10-15% of NSCLC patients in the United States and Europe
and 30-40% of NSCLC patients in Asia, are particularly sensitive to
treatment with currently available EGFR-TKIs. However, tumors
almost always develop resistance to treatment leading to disease
progression. Combining therapies that inhibit different signaling
pathways has the potential to be more effective than inhibition of
a single pathway and to overcome tumor resistance.
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 without known off-target toxicities. It is
currently under the joint development in China by Chi-Med and its
partner Eli Lilly and Company. Two late-stage, pivotal Phase III
registration studies are ongoing in colorectal cancer (FRESCO) and
lung cancer (FALUCA). In addition, fruquintinib is also in clinical
development for gastric cancer.
Colorectal: The FRESCO trial is a randomized, double-blind,
placebo-controlled, multi-center, Phase III pivotal trial in
patients with locally advanced or metastatic colorectal cancer who
have failed at least two prior systemic antineoplastic therapies,
including fluoropyrimidine, oxaliplatin and irinotecan. Enrollment
was completed in May 2016. 416 patients were randomized at a 2:1
ratio to receive either: 5 mg of fruquintinib orally once per day,
on a three-weeks-on / one-week-off cycle, plus best supportive care
("BSC"); or placebo plus BSC. The primary endpoint is overall
survival ("OS"), with secondary endpoints including progression
free survival ("PFS"), objective response rate, disease control
rate and duration of response. Additional details of the FRESCO
study may be found at clinicaltrials.gov, using identifier
NCT02314819.
Lung: The FALUCA trial is a randomized, double-blind,
placebo-controlled, multi-center, Phase III registration study
targeted at treating patients with advanced non-squamous NSCLC, who
have failed two lines of systemic chemotherapy. Enrollment began in
December 2015. Patients are randomized at a 2:1 ratio to receive
either: 5 mg of fruquintinib orally once per day, on a
three-weeks-on / one-week-off cycle, plus BSC; or placebo plus BSC
. The primary endpoint is OS, with secondary endpoints including
PFS, ORR, DCR and duration of response. Chi-Med plans to enroll
approximately 520 patients in about 45 centers across China.
Additional details about FALUCA study may be found at
clinicaltrials.gov, using identifier NCT02691299.
Gastric: Chi-Med completed a Phase Ib dose finding study of
fruquintinib in combination with paclitaxel, which established a
combination regimen that was well tolerated. Additional details
about this study may be found at clinicaltrials.gov, using
identifier NCT02415023.
About Iressa(R) , an EGFR-TKI
Iressa(R) (gefitinib) is a targeted monotherapy developed by
AstraZeneca for the treatment of patients with advanced or
metastatic EGFR activating mutation positive NSCLC. Iressa(R) acts
by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking
the transmission of signals involved in the growth and spread of
tumors. Iressa(R) is approved in 91 countries worldwide.
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: 0001). 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. In addition, as certain studies rely on
the use of Iressa(R) as a combination therapeutic with
fruquintinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of Iressa(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
Christian Hogg, CEO +852 2121 8200
International Media Enquiries
Anthony Carlisle, +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
Citigate Dewe Rogerson
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, +44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Citigate Dewe Rogerson
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
NRAGGUGGGUPMUMQ
(END) Dow Jones Newswires
January 16, 2017 02:16 ET (07:16 GMT)