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Hutchison China Meditech Limited
04 September 2020
Press Release
Chi-Med Initiates FRESCO-2, a Global Phase III Trial of
Fruquintinib in Metastatic Colorectal Cancer
Hong Kong, Shanghai, & Florham Park, NJ: Friday, September
4, 2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) has initiated FRESCO-2, a Phase III registration study of
fruquintinib for the treatment of patients with metastatic
colorectal cancer ("CRC") in the U.S., Europe and Japan. The first
patient was dosed on September 3, 2020, in the U.S.
FRESCO-2 is a randomized, double-blind, placebo-controlled,
multicenter trial being conducted in patients with metastatic CRC.
The primary endpoint of the study is overall survival. This large
phase III trial will be enrolled in approximately 130 sites in 10
countries. Additional details of the study may be found at
clinicaltrials.gov, using identifier NCT04322539.
The U.S. Food and Drug Administration ("FDA") granted Fast Track
Designation for the development of fruquintinib for the treatment
of patients with metastatic CRC in June 2020. Clinical data
including the completed Phase III FRESCO study in Chinese patients
and this FRESCO-2 global study, if positive, would support a future
New Drug Application (NDA) for the treatment of patients with
advanced metastatic CRC (third-line and above), based on our
agreement with the FDA. The FRESCO-2 study design was also reviewed
and endorsed by the European Medicines Agency (EMA) and the
Japanese Pharmaceuticals and Medical Devices Agency (PMDA).
About CRC
CRC is cancer that starts in either the colon or rectum. CRC is
the third most common cancer worldwide, causing more than 860,000
deaths in 2018.[1] In the U.S., it is estimated that 150,000 people
will be diagnosed with CRC and 53,000 people will die from CRC in
2020.[2] In Europe, CRC is the second most common cancer, with an
estimated 490,000 new cases and 240,000 deaths in 2018.[3] In
Japan, CRC is the most common cancer, with an estimated 150,000 new
cases and 57,000 deaths in 2018.[4]
About Fruquintinib
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR
inhibitors play a pivotal role in blocking tumor angiogenesis.
Fruquintinib was designed to improve kinase selectivity to minimize
off-target toxicities, improve tolerability and provide more
consistent target coverage. The generally good tolerability in
patients to date, along with fruquintinib's low potential for
drug-drug interaction based on preclinical assessment, suggests
that it may also be highly suitable for combinations with other
anti-cancer therapies.
Chi-Med retains all rights to fruquintinib outside of China and
is partnered with Eli Lilly and Company ("Lilly") in China.
About Fruquintinib in metastatic CRC
Fruquintinib was approved for marketing by the China National
Medical Products Administration (NMPA) in September 2018 and
commercially launched by Lilly in late November 2018 under the
brand name Elunate(R) . Elunate(R) is for the treatment of patients
with metastatic CRC that have been previously treated with
fluoropyrimidine, oxaliplatin and irinotecan, including those who
have previously received anti-VEGF therapy and/or anti-EGFR therapy
(RAS wild type). Results of the FRESCO study, a Phase III pivotal
registration trial of fruquintinib in 416 patients with metastatic
CRC in China, were published in The Journal of the American Medical
Association, JAMA, in June 2018 (clinicaltrials.gov identifier:
NCT02314819).
In December 2017, Chi-Med initiated a multi-center, open-label,
Phase I/Ib clinical study to evaluate the safety, tolerability and
pharmacokinetics of fruquintinib in U.S. patients with advanced
solid tumors (clinicaltrials.gov identifier: NCT03251378).
Proof-of-concept cohorts in patients with metastatic CRC and
metastatic breast cancer were added in 2019.
Other Fruquintinib Development
Gastric Cancer in China : In October 2017, Chi-Med initiated the
FRUTIGA study, a randomized, double-blind, Phase III trial
evaluating the efficacy and safety of fru quintinib combined with
paclitaxel for second-line treatment of advanced g astric or
esophagogastric junction ("GEJ") a denocarcinoma. The trial is
designed to enroll patients who did not respond to first-line
standard chemotherapy. Subjects will receive either fruquintinib
combined with paclitaxel or placebo combined with paclitaxel.
Patients will be randomized at a 1:1 ratio and stratified according
to factors such as stomach vs. GEJ tumor type and performance
status. The primary efficacy endpoint is overall survival.
Secondary efficacy endpoints include progression-free survival (as
defined by RECIST 1.1), objective response rate, disease control
rate, duration of response, and quality-of-life score (EORTC
QLQ-C30, version 3.0). Biomarkers related to the antitumor activity
of fruquintinib will also be explored (clinicaltrials.gov
identifier NCT03223376). In June 2020, Chi-Med completed a planned
interim data review. Based on the preset criteria, the Independent
Data Monitoring Committee (IDMC) recommended that the trial
continue.
Immunotherapy combinations: Chi-Med has entered into three
collaboration agreements to evaluate the safety, tolerability and
efficacy of fruquintinib in combination with programmed death-1
(PD-1) monoclonal antibodies, including with tislelizumab
(BGB-A317, developed by BeiGene, Ltd.), Tyvyt (R) (sintilimab,
IBI308, developed by Innovent Biologics, Inc.) and geptanolimab
(GB226, developed by Genor Biopharma Co. Ltd.).
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative, commercial-stage,
biopharmaceutical company committed, over the past twenty years, to
the discovery and global development of targeted therapies and
immunotherapies for the treatment of cancer and immunological
diseases. It has a portfolio of nine cancer drug candidates
currently in clinical studies around the world and extensive
commercial infrastructure in its home market of China. 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 regarding the clinical
development of fruquintinib in CRC in the United States, Europe and
Japan, the potential therapeutic benefits of fruquintinib in CRC,
Chi-Med's clinical development plans for fruquintinib in other
jurisdictions and indications as well as the growth of Chi-Med.
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 fruquintinib, including as
a combination therapy, to meet the primary or secondary endpoint of
a study, its ability to fund, implement and complete its further
clinical development and commercialization plans for fruquintinib,
the timing of these events, and the impact of the COVID-19 pandemic
on general economic, regulatory and political conditions. In
addition, as certain studies rely on the use of combination
therapeutics with fruquintinib, such risks and uncertainties
include assumptions regarding the safety, efficacy, supply and
continued regulatory approval of such combination therapeutics.
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
Media Enquiries
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile), bmiles@troutgroup.com
Europe - Ben Atwell / Alex Shaw, FTI Consulting +44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779
545 055 (Mobile)
Chi-Med@fticonsulting.com
Asia - Joseph Chi Lo / Zhou Yi, Brunswick +852 9850 5033 (Mobile), jlo@brunswickgroup.com / +852 97
83 6894 (Mobile), y zhou@brunswickgroup.com
Nominated Advisor
Freddy Crossley / Atholl Tweedie, Panmure Gordon (UK)
Limited +44 (20) 7886 2500
[1] Ferlay J, Ervik M, Lam F, Colombet M, Mery L, Piñeros M,
Znaor A, Soerjomataram I, Bray F (2018). Global Cancer Observatory:
Cancer Today. Lyon, France: International Agency for Research on
Cancer. Available from: https://gco.iarc.fr/today
[2] SEER, Cancer Stat Facts: Colorectal Cancer.
seer.cancer.gov/statfacts/html/colorect.html
[3] The Global Cancer Observatory, Europe fact sheet.
gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf
[4] The Global Cancer Observatory, Japan fact sheet.
gco.iarc.fr/today/data/factsheets/populations/392-japan-fact-sheets.pdf
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