Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq:HCM)
has initiated FRUTIGA, a pivotal Phase III clinical trial of
fruquintinib in combination
with paclitaxel (Taxol®) for
the treatment in advanced
gastric or gastroesophageal
junction (“GEJ”) adenocarcinoma
patients in China. Fruquintinib is a highly selective and potent
oral inhibitor of vascular endothelial growth factor receptors
(“VEGFR”) 1, 2 and 3. This randomized, double-blind,
placebo-controlled, multicenter trial is being conducted in
patients with advanced gastric cancer who have progressed after
first-line standard chemotherapy. Advanced gastric cancer is a
major medical need, particularly in Asian populations, with limited
treatment options for patients who have failed first-line standard
chemotherapy with 5-fluorouracil (5-FU) and platinum doublets. For
gastric cancer, there are approximately 679,100 new cases and
498,000 deaths in China each year.[1]
“Fruquintinib was designed to be a highly selective inhibitor of
VEGFR 1, 2 and 3, which has shown the potential ability to combine
with chemotherapy – a novel approach in the treatment of advanced
gastric cancer,” said Christian Hogg, Chief Executive Officer of
Chi-Med. “With fruquintinib’s New Drug Application (“NDA”) in
third-line colorectal cancer (“CRC”) under review and its Phase III
trial in third-line non-small cell lung cancer nearing full
enrollment, we are excited to now also enter the final phase of
development in second-line gastric cancer, a very large indication
in which there is significant patient need for new treatment
options in China.”
About FRUTIGA
Over 500 patients will be enrolled into FRUTIGA, a randomized,
double-blind, Phase III trial to evaluate the efficacy and safety
of fruquintinib combined with paclitaxel compared with paclitaxel
monotherapy for second-line treatment of advanced gastric or GEJ
adenocarcinoma. The trial will enroll patients with disease that
has been confirmed through histology or cytology and who did not
respond to first-line standard chemotherapy containing platinum and
fluorouracil. All subjects will receive fruquintinib or placebo
combined with paclitaxel. Patients will be randomized at a 1:1
ratio and stratified according to factors such as stomach vs. GEJ
tumors and ECOG performance status. An Independent Data Monitoring
Committee (IDMC) will be established to review safety and efficacy
data.
The Primary efficacy endpoint is overall survival (“OS”).
Secondary efficacy endpoints include progression-free survival
(“PFS”, as defined by RECIST 1.1), objective response rate (“ORR”),
disease control rate (“DCR”), 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.
Additional details about this study can be found at
clinicaltrials.gov, using identifier NCT03223376.
FRUTIGA was initiated following the results of an open label,
multi-center Phase Ib dose finding/expansion study of
fruquintinib in combination with paclitaxel (Taxol®) in second-line
patients with advanced gastric cancer (clinicaltrials.gov
identifier NCT02415023). Results were presented at the American
Society of Clinical Oncology Gastrointestinal Cancers Symposium in
January 2017. A total of 32 patients were enrolled in the study and
28 of 32 patients were evaluable for efficacy, with an ORR rate of
36% and a DCR of 68%. At the fruquintinib recommended Phase II dose
(“RP2D”), ≥16 week PFS rate was 50% and ≥7 month OS was 50%.
Tolerability of the RP2D combination was as expected with common
treatment related Grade ≥3 adverse events (AEs) being neutropenia
(41%), leukopenia (28%), decreased hemoglobin (6%), and hand-foot
syndrome (6%).
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. 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 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, 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.
At an advanced stage, tumors secrete large amounts of VEGF, a
protein ligand, to stimulate formation of excessive vasculature
(angiogenesis) around the tumor to provide greater blood flow,
oxygen, and nutrients to the tumor. VEGF and VEGFR play pivotal
roles in tumor-related angiogenesis, and fruquintinib inhibits the
VEGF/VEGFR pathway. This represents an important therapeutic
strategy in blocking the development of new blood vessels essential
for tumors to grow and invade.
Fruquintinib is currently under joint development in China by
Chi-Med and its partner Eli Lilly and Company.
About Fruquintinib Development in Other Cancer Types
The China Food and Drug Administration (“CFDA”) acknowledged
acceptance of the NDA for fruquintinib for the treatment of
patients with advanced colorectal cancer in June 2017, and was
subsequently awarded priority review status in view of its
significant clinical value, according to the 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 on June 5, 2017
(clinicaltrials.gov identifier NCT02314819).
In addition to the FRUTIGA and FRESCO Phase III trials,
fruquintinib is being studied in China in a Phase III pivotal trial
in non-small cell lung cancer (“NSCLC”), known as FALUCA
(clinicaltrials.gov identifier NCT02691299); and a Phase II study
using fruquintinib combined with Iressa® (gefitinib) in the
first-line setting for patients with advanced or metastatic NSCLC
(clinicaltrials.gov identifier NCT02976116). Other studies
currently being planned include new studies in the United States
(clinicaltrials.gov identifier NCT03251378), and certain
exploratory studies in combination with other oncology agents.
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. 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.
1 CA Cancer J. Clin., 2016, 66: 115-132.
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version on businesswire.com: http://www.businesswire.com/news/home/20171031005613/en/
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