– Data to show potential of savolitinib to
treat EGFR-TKI resistance in both Iressa® and Tagrisso® refractory
patients with MET amplification –
– Results to further validate Chi-Med’s
scientific strategy of designing highly selective small molecule
TKIs that can be safely and effectively used in combination
regimens –
– Updated data through August 2017 will be
reviewed on-site in three oral presentations –
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that non-small cell lung cancer (“NSCLC”)
proof-of-concept clinical data on two of its novel tyrosine kinase
inhibitors (“TKI”), savolitinib and fruquintinib, will be presented
at the 18th World Conference on Lung Cancer (“WCLC”), to be held in
Yokohama, Japan from October 15 to 18, 2017. The three
oral presentations cover the following studies in epidermal
growth factor receptor (“EGFR”)-mutant NSCLC patients:
Savolitinib plus Tagrisso® (osimertinib) for
EGFR-mutant MET amplified NSCLC patients after progression on prior
EGFR-TKI, predominantly Iressa® (gefitinib) or
Tarceva® (erlotinib)
The proof-of-concept TATTON B study demonstrated promising
safety, tolerability, and efficacy of this combination. Data was
not yet mature at abstract data cut-off (April 2017). The
presentation will include data up to and including August 2017,
including further patient enrolment, response confirmations, and
duration of response results.
Title:
OA 09.03 – TATTON Ph Ib Expansion Cohort:
Osimertinib plus Savolitinib for Pts with EGFR-Mutant MET-Amplified
NSCLC after Progression on Prior EGFR-TKI Presenting Author:
Myung-Ju Ahn Authors: Ji-Youn Han, Lecia V Sequist, Byoung Chul
Cho, J.S. Lee, Sang-We Kim, W. Su, C. Tsai, James Chih-Hsin Yang,
Helena Yu, L. Horn, K. Lee, V. Haddad, M.M. Frigault, G. Ahmed, L.
Yang, D. Ghiorghiu, Geoffrey R. Oxnard Time & Location: Tuesday
October 17, 2017, 11:20AM – 11:30AM, Room 301 + 302 Session: OA 09
– EGFR TKI Resistance (ID 663)
Savolitinib plus Iressa® (gefitinib) for
EGFR-mutant MET amplified NSCLC patients after progression on prior
EGFR-TKI
This proof-of-concept study in China demonstrated promising
safety, tolerability, and efficacy of this combination. Data was
not yet mature at abstract data cut-off (March 2017). The
presentation will include data up to and including August 2017,
including further patient enrolment, response confirmations,
duration of response results, and confirmation of T790M status for
each patient.
Title:
OA 09.06 – A Phase Ib Trial of Savolitinib plus
Gefitinib for Chinese Patients with EGFR-Mutant MET-Amplified
Advanced NSCLC Presenting Author: Jin-Ji Yang Authors: Jian
Fang, Y. Shu, J. Chang, G. Chen, J. He, W. Li, X. Liu, N. Yang,
Caicun Zhou, J. Huang, L. Yang, A.A. Handzel, M.M. Frigault, G.
Ahmed, C. Egile, S. Morgan, Yi-Long Wu Time & Location: Tuesday
October 17, 2017, 11:55AM – 12:05PM, Room 301 + 302 Session: OA 09
– EGFR TKI Resistance (ID 663)
Fruquintinib plus Iressa® in stage IIIb/IV
EGFR-mutant NSCLC patients
This proof-of-concept study in first-line EGFR-mutant NSCLC
demonstrated no unexpected toxicities and a manageable preliminary
safety profile of this combination. Data was not yet mature at
abstract data cut-off (June 2017). The presentation will include
data up to and including August 2017, including further patient
enrolment, safety and efficacy results.
Title:
JCSE 01.12 – A Phase II Study of Fruquintinib in
Combination with Gefitinib in Stage IIIb/IV NSCLC Patients
Harboring EGFR Activating Mutations Presenting Author: Shun Lu
Authors: J. Zhou, X. Niu, M. Chen, Y. Hua, W. Su Time &
Location: Sunday October 15, 2017, 10:35AM – 10:50AM, F203 (Annex
Hall) Session: JCSE 01 – Joint IASLC / CSCO / CAALC Session:
Immunotherapy for Management of Lung Cancer: Ongoing Research from
East and West (ID 630) Poster Note: The study detailed in oral
presentation JCSE 01.12 will also be presented as poster P3.01-070
as part of the Advanced NSCLC poster session on Wednesday October
18, 2017 at 9:30AM, in Exhibit Hall (B + C).
Once presented, the presentations will be available at
www.chi-med.com/news/. Further information about WCLC is available
at www.wclc2017.iaslc.org.
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 PLC. AstraZeneca PLC 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 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 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.
Tagrisso® and Iressa® are trademarks of the AstraZeneca PLC
group of companies. Tarceva® is a trademark of the Astellas Pharma
Inc. group of companies.
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 and savolitinib, plans to initiate clinical studies
for fruquintinib and savolitinib, 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 and savolitinib 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 and savolitinib 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 Tagrisso® (osimertinib) or Iressa® (gefitinib) as
a combination therapeutic with savolitinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and continued regulatory approval of Iressa® 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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version on businesswire.com: http://www.businesswire.com/news/home/20170928006461/en/
Chi-MedInvestor EnquiriesMark LeeSenior Vice
President, Corporate Finance & Development+852 2121
8200orU.K. & International 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.comorSusan Duffy, BMC
Communications+1 (917) 499 8887
(Mobile)sduffy@bmccommunications.comorInvestor RelationsMatt
Beck, The Trout Group+1 (917) 415 1750
(Mobile)mbeck@troutgroup.comorDavid 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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