– FRESCO Phase III trial results for
fruquintinib in colorectal cancer in an
oral presentation –
– Five abstracts in total accepted for
fruquintinib, savolitinib and sulfatinib –
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that new clinical data on three of its novel
tyrosine kinase inhibitors, fruquintinib, savolitinib and
sulfatinib, will be presented at the 2017 American Society of
Clinical Oncology (“ASCO”) Annual Meeting, to be held in Chicago,
Illinois from June 2 to 6, 2017.
The five presentations, one oral presentation and four poster
presentations, cover the following studies:
Fruquintinib:
- The full results of the FRESCO Phase
III study in 416 patients with locally advanced or metastatic
colorectal cancer (“CRC”) will be highlighted in an oral
presentation on June 5, 2017. Primary endpoint median overall
survival was 9.30 months for fruquintinib versus 6.57 months in the
control group, with a hazard ratio of 0.65 and p< 0.001.
Fruquintinib was well tolerated, with manageable on-target
treatment related adverse events consistent with
previous studies.
Savolitinib:
- c-MET amplification (“amp”) is a major
acquired resistance (“AR”) pathway to Tagrisso® (osimertinib).
AstraZeneca PLC (“AstraZeneca”) will highlight an analysis of 23
EGFR-mutant non-small-cell lung cancer (“NSCLC”) patients with AR
to Tagrisso®. Analysis shows that about 30% (7/23 patients) of AR
is c-MET amp and that among the 7 patients with c-MET amp, 3
patients received combination Tagrisso®/savolitinib therapy; all 3
had partial response (“PR”) under RECIST (Response Evaluation
Criteria in Solid Tumors) guidelines.
- Savolitinib included in PAPMET Phase II
study (sponsored by NIH/NCI) of multiple c-MET and vascular
endothelial growth factor receptor (“VEGFR”) tyrosine kinase
inhibitors in metastatic papillary renal cell carcinoma patients.
PAPMET will evaluate four therapies in a 1:1:1:1 randomization,
sunitinib, cabozantinib, crizotinib and savolitinib in an about
275-patient study which began in 2016 and as at January 30, 2017
had registered 26 patients. PAPMET will study efficacy, safety and
correlation of clinical outcome with tumor molecular driver
alterations such as c-MET.
- Update on the VIKTORY trial, a
biomarker-based umbrella trial in gastric cancer. From June 2014 to
January 2017, a total of 432 metastatic gastric cancer patients
were enrolled in VIKTORY, a total of 23 patients (5.3%) were guided
into savolitinib monotherapy treatment (4/23 patients) or
savolitinib/docetaxel combination therapy (19/23) based on
molecular screening outcomes.
Sulfatinib:
- Preliminary results of a Phase II study
in advanced medullary thyroid cancer (“MTC”) and radioiodine
(“RAI”)-refractory differentiated thyroid cancer (“DTC”).
Sulfatinib is an oral, novel angio-immuno kinase inhibitor that
selectively targets VEGFR, fibroblast growth factor receptor-1
(“FGFR”) and colony-stimulating factor-1 receptor (“CSF-1R”). As at
December 31, 2016 a total of 18 patients had been enrolled with 1/6
MTC patients and 3/12 RAI-DTC patients reporting confirmed PRs, and
all other patients stable disease, under RECIST.
Presentation Details
Abstracts for the presentations are available at
abstracts.asco.org, as listed below:
Fruquintinib:
Title: A randomized, double-blind,
placebo-controlled, multi-centered phase III trial comparing
fruquintinib versus placebo plus best supportive care in Chinese
patients with metastatic colorectal cancer (FRESCO) Abstract
#: 3508
Presenter: Dr. Jin Li, Oncologist and Director
of the Tumor Department, Shanghai East Hospital, Tongji University
School of Medicine
Authors: J Li, S Qin, RH Xu, J Xu, L
Shen, Y Bai, Y Deng, L Yang, ZD Chen, H Zhong, H Pan, W Guo, Y Shu,
Y Yuan, J Zhou
Session: Gastrointestinal (Colorectal) Cancer
– Oral Abstract Session
Date & Time: Monday, June 5,
2017, 5:24 PM CDT
Location: Hall D2
Savolitinib:
Title: MET amplification (amp) as a resistance
mechanism to osimertinib Abstract #: 9020
Authors: Z Piotrowska, K Thress, M Mooradian, RS Heist, CG
Azzoli, J Temel, C Rizzo, R Nagy, R Lanman, S Gettinger, T Evans, A
Hata, A Shaw, LV Sequist
Session: Lung Cancer—Non-Small Cell
Metastatic
Date & Time: Saturday, June 3, 08:00 - 11:30
AM CDT
Location: Hall A
Title: A
randomized, phase II efficacy assessment of multiple MET kinase
inhibitors in metastatic papillary renal carcinoma (PRCC): SWOG
S1500 Abstract #: TPS4599
Authors: SK Pal, C
Tangen, IM Thompson, B Shuch, NB Haas, DJ George, M Stein, M Plets,
PN Lara
Session: Genitourinary (Nonprostate) Cancer
Date
& Time: Sunday, June 4, 08:00 – 11:30 AM CDT
Location: Hall A
Title: VIKTORY trial:
Report on AZD1775/paclitaxel in TP53 mutation (+) GC,
selumetinib/paclitaxel in ras aberrant GC, AZD5363/paclitaxel in
PIK3CA mt and biomarker negative, savolitinib/docetaxel in met (+),
and vistusertib/paclitaxel in RICTOR(+) GC Abstract #:
4024
Authors: J Lee, ST Kim, PG Mortimer, S Hollingsworth, E
Harrington, C Shepherd, E Kilgour, SH Park, H Lee, SY Oh, JH Kang,
JO Park, YS Park, HY Lim, KM Kim, WK Kang
Session:
Gastrointestinal (Noncolorectal) Cancer
Date & Time:
Saturday, June 3, 08:00 – 11:30 AM CDT
Location: Hall A
Sulfatinib:
Title: A phase II multicenter trial of the multitargeted
kinase inhibitor sulfatinib in advanced medullary thyroid cancer
(MTC) and radioiodine (RAI)-refractory differentiated thyroid
cancer (DTC) Abstract #: 6037
Authors: J Chen, Q
Ji, J Cao, D Ji, C Bai, Y Lin, B Pan, G Sun, J Li, C Qi, Y Hua
Session: Head and Neck Cancer
Date & Time:
Monday, June 5, 1:15 PM CDT
Location: Hall A
Once presented, the presentations will be available at
www.chi-med.com/news/. Further information about ASCO is available
at asco.org.
About Fruquintinib
Fruquintinib 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. Its tolerability, along
with its clean drug-drug interaction profile, enables 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 a pivotal
role in tumor-related angiogenesis, and the inhibition of 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 (“Lilly”). Chi-Med
and Lilly jointly announced top-line results from the FRESCO CRC
trial on March 3, 2017. In addition, fruquintinib is being studied
in China in a Phase III pivotal trial in NSCLC, known as FALUCA;
and a Phase II study using fruquintinib combined with Iressa®
(gefitinib) in the first-line setting for patients with advanced or
metastatic NSCLC. Other studies currently being planned, and soon
to be initiated, include a Phase III study in gastric cancer in
combination with paclitaxel in China, new studies in the United
States, and certain exploratory studies in combination with other
oncology agents.
About Savolitinib
Savolitinib (AZD6094/HMPL-504) is a potential global
first-in-class inhibitor of c-MET (also known as mesenchymal
epithelial transition factor) receptor tyrosine kinase, an enzyme
which has been shown to function abnormally in many types of solid
tumors. It was developed as a potent and highly selective oral
inhibitor specifically designed to address issues observed in the
clinic with first-generation c-MET inhibitors, including
renal toxicity.
Savolitinib was discovered by Chi-Med and is being developed in
collaboration with AstraZeneca. AstraZeneca and Chi-Med are
currently testing savolitinib in multiple tumor types worldwide
including kidney, lung and gastric cancers, both as a monotherapy
or in combination with other targeted and
immunotherapy agents.
About Sulfatinib
Sulfatinib is an oral, novel angio-immunokinase inhibitor that
selectively inhibits the tyrosine kinase activity associated with
VEGFR, FGFR and CSF-1R, three key tyrosine kinase receptors
involved in tumor angiogenesis and immune evasion. Inhibition of
the VEGFR signaling pathway can act to stop angiogenesis, the
growth of the vasculature around the tumor, and thereby starve the
tumor of the nutrients and oxygen it needs to grow rapidly.
Aberrant activation of the FGFR signaling pathway, which can be
increased by anti-VEGFR therapy treatment, is shown to be
associated with cancer progression by promoting tumor growth,
angiogenesis and formation of the myeloid derived suppressor cells.
Inhibition of the CSF-1R signaling pathway blocks the activation of
tumor-associated macrophages, which are involved in suppressing
immune responses against tumors.
Six sulfatinib clinical trials are underway in China and the
United States, including two Phase III studies and one Phase II
study in neuroendocrine tumors patients (SANET-p, SANET-ep and
SANET-1), one Phase II study in thyroid cancer patients and one
Phase II study in biliary tract cancer patients.
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, savolitinib and sulfatinib, plans to initiate
clinical studies for fruquintinib, savolitinib and sulfatinib, 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 candidates
fruquintinib, savolitinib and sulfatinib 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, savolitinib and sulfatinib for a targeted indication
and the sufficiency of funding. In addition, as certain studies
rely on the use of Iressa® (gefitinib) as a combination therapeutic
with fruquintinib and docetaxel and Tagrisso® (osimertinib) as a
combination therapeutic with savolitinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and continued regulatory approval of Iressa®, docetaxel and
Tagrisso®. 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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