Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that data from the ongoing Phase I/II clinical
trial of fruquintinib in combination with paclitaxel (Taxol®) in
second-line patients with advanced gastric cancer will be presented
at the 2017 Gastrointestinal Cancers Symposium sponsored by the
American Society of Clinical Oncology (“ASCO-GI”), being held in
San Francisco, California from January 19 to 21, 2017.
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptors (“VEGFR”).
Chi-Med completed a Phase Ib dose finding study of fruquintinib
in combination with paclitaxel, which established a combination
regimen that was well tolerated, and continued to enroll patients
in this trial to expand the data-set. Additional details about this
study may be found at clinicaltrials.gov, using identifier
NCT02415023.
The most recent results of the study will be presented in detail
as follows:
Presentation Title: A Phase I/II trial of
Fruquintinib in Combination with Paclitaxel for Second-line
Treatment in Patients with Advanced Gastric Cancer
Authors:
Ruihua Xu, Dongsheng Zhang, Lin Shen, Jin Li, Jing Huang, Yang
Zhang, Jifang Gong, Weijian Guo, Songhua Fan, Ke Li, Ye Hua and
Weiguo Su
Abstract No: 128
Session: Poster Session A:
Cancers of the Esophagus and Stomach
Date & Time:
Thursday, January 19, 2017, 12:30 PM-6:30 PM (PST)
Once presented, the presentation will be available at
www.chi-med.com/news. Further information about ASCO-GI is
available at gicasym.org.
ABSTRACT
A Phase I/II Trial of Fruquintinib in
Combination with Paclitaxel for Second-line Treatment in Patients
with Advanced Gastric Cancer
Ruihua Xu, Dongsheng Zhang, Lin Shen, Jin Li, Jing Huang, Yang
Zhang, Jifang Gong, Weijian Guo, Songhua Fan, Ke Li, Ye Hua and
Weiguo Su
Background
Advanced gastric cancer is a major public health problem,
particularly in Asian countries. The treatment options are limited
in patients who failed standard first-line chemotherapy. This Phase
I/II study is aimed to evaluate the tolerability, pharmacokinetics
(“PK”) and preliminary efficacy of fruquintinib, a selective oral
VEGFR inhibitor, combined with paclitaxel as second-line therapy in
Chinese patients with advanced gastric cancer.
Patients and methods
This open arm Phase I/II trial (NCT02415023) consisted of dose
finding and dose expansion stages. In the dose finding stage, three
dose levels of fruquintinib (2, 3, 4mg once daily; three-weeks-on
and one-week-off) were evaluated in combination with standard
80mg/m2 paclitaxel (once weekly on day 1, 8 and 15) in a 28-day
cycle until the maximum tolerated dose (“MTD”) or recommended phase
II dose (“RP2D”) was reached. Additional patients were enrolled at
dose expansion phase with fruquintinib RP2D regimen to assess
further the efficacy, safety and PK profile.
Results
As of September 10, 2016, a total of 32 patients were enrolled
and dosed with fruquintinib in combination with weekly paclitaxel.
The RP2D of fruquintinib was determined to be 4 mg daily.
Two patients at 4 mg experienced dose-limiting toxicity, both
with febrile neutropenia. Grade 3 or 4 treatment emergent adverse
events (“TEAE”) were neutropenia (40.6%), leukopenia (28.1%),
decreased hemoglobin (6.25%), hand-foot skin reaction (6.25%),
neurophlegmon (6.25%), and hypertension (6.25%), with higher
frequencies in the 4mg cohort as compared with lower doses.
At steady state, fruquintinib drug exposure, i.e. the area under
the curve (AUCss), increased dose-proportionally and was within the
same range as given as a single agent. Paclitaxel exposure at
fruquintinib RP2D (4mg) however, increased by approximately 30% as
compared to that of single agent.
28 of 32 patients were evaluable for tumor response, and of
these, 10 patients achieved confirmed partial response (objective
response rate, (“ORR”) = 35.7%), 9 patients experienced stable
disease for at least 8 weeks (disease control rate, (“DCR”) =
67.9%). At fruquintinib RP2D, ≥16w progression free survival
(“PFS”) = 50% and ≥7m overall survival (“OS”) = 50%.
Conclusion
Combination therapy of fruquintinib and paclitaxel appeared to
be generally well-tolerated with promising tumor response in the
second-line setting in advanced gastric cancer. Further evaluation
of fruquintinib in a randomized control trial is warranted.
About Gastric Cancer
Every year, it is estimated that approximately one million new
patients around the world are diagnosed with gastric cancer,
according to Frost & Sullivan, and in 2015 China represented
approximately 44% of all newly diagnosed gastric cancer cases
worldwide. The very high prevalence of gastric cancer in China as
compared to the rest of the world is thought to be linked in part
to food preparation habits, such as the use of certain
preservatives. In 2015 there were an estimated 679,100 incidence
gastric cancer cases and 498,000 mortality cases in China,
according to the National Central Cancer Registry of China.
Gastric cancer is the third of most lethal cancer worldwide. As
it is often diagnosed at an advanced stage, prognosis is poor with
a median OS of less than 12 months. Although targeted therapy is
under development in China, chemotherapy remains the mainstay of
treatment for gastric cancer patients and confers only a moderate
survival advantage. Accordingly, we see a high medical need for new
targeted treatment options.
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) along with the currently reported gastric
cancer trial.
Colorectal: The FRESCO trial is a randomized,
double-blind, placebo-controlled, multicenter, 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: 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. The primary endpoint
is OS, with secondary endpoints including PFS, ORR, DCR 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: 5mg 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 this study may be found at
clinicaltrials.gov, using identifier NCT02691299.
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 paclitaxel as a combination therapeutic with
fruquintinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of paclitaxel. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20170116005219/en/
Chi-MedInvestor EnquiriesChristian Hogg, CEO+852
2121 8200orInternational Media EnquiriesAnthony Carlisle,
Citigate Dewe Rogerson+44 7973 611 888
(Mobile)anthony.carlisle@cdrconsultancy.co.ukorU.S. Based Media
EnquiriesBrad Miles, BMC Communications+1 (917) 570 7340
(Mobile)bmiles@bmccommunications.comororSusan Duffy, BMC
Communications+1 (917) 499 8887
(Mobile)sduffy@bmccommunications.comororInvestor
RelationsMatt Beck, The Trout Group+1 (917) 415 1750
(Mobile)mbeck@troutgroup.comororDavid Dible, Citigate Dewe
Rogerson+44 7967 566 919
(Mobile)david.dible@citigatedr.co.ukorPanmure Gordon (UK)
LimitedRichard Gray / Andrew Potts+44 (20) 7886 2500
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