TIDMHCM
RNS Number : 7831T
Hutchison China Meditech Limited
17 October 2017
Chi-Med and AstraZeneca's Savolitinib Shows Encouraging Clinical
Activity in Second-Line EGFR Mutation-Positive Lung Cancer with
MET-Amplification
- Data for savolitinib in combination with Tagrisso(R) or
Iressa(R) presented at World Conference on Lung Cancer -
- New data give insights into disease progression and potential
next-generation treatment strategies in patients with EGFR-mutated
NSCLC with MET amplification -
London: Tuesday, October 17, 2017: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) and AstraZeneca PLC
("AstraZeneca") today presented preliminary safety and clinical
activity data of savolitinib when given in combination with either
Tagrisso(R) (osimertinib) or Iressa(R) (gefitinib) in two Phase
Ib/II proof-of-concept trials conducted in patients with epidermal
growth factor receptor ("EGFR") mutation-positive ("EGFRm")
non-small cell lung cancer ("NSCLC") with MET-amplification who had
progressed following first-line treatment with an EGFR inhibitor.
In both trials, the addition of savolitinib (600mg, once daily), an
investigational selective inhibitor of mesenchymal epithelial
transition factor ("c-MET") receptor tyrosine kinase, to
Tagrisso(R) (80mg, once daily) or Iressa(R) (250mg, once daily)
demonstrated preliminary anti-tumor activity. The data were shared
in two oral presentations at the International Association for the
Study of Lung Cancer 18(th) World Conference on Lung Cancer
("WCLC") in Yokohama, Japan, October 15 to 18, 2017.
Dr. Myung-Ju Ahn, Department of Hematology & Oncology,
Samsung Medical Center, Seoul, South Korea, said, "Secondary
resistance mechanisms often emerge during treatment with
mutation-targeted medicines, leading to disease progression. The
data presented at WCLC demonstrate the potential of utilizing
savolitinib in c-MET-driven lung cancers to address resistance
challenges."
Susan Galbraith, Head of Oncology, AstraZeneca Research and
Early Development, said, "We are committed to developing innovative
medicines to overcome the key drivers of cancer mechanisms of
resistance and are strategically focused on developing effective
combinations. The latest results for savolitinib in combination
with osimertinib and gefitinib support our approach in
collaboration with Chi-Med."
Preliminary Results for Savolitinib in Combination with
Tagrisso(R)[ [1](])
In the Phase Ib/II proof-of-concept TATTON trial in patients
with EGFRm advanced NSCLC with MET-amplification confirmed locally
or centrally, early data on safety and anti-tumor activity for
savolitinib in combination with Tagrisso(R) were presented. In 66
patients treated, the most common all-causality adverse events
("AEs") were nausea (44%), vomiting (35%), fatigue (30%), and
decreased appetite (30%), which were consistent with the known
safety profiles of savolitinib and Tagrisso(R) .
Preliminary data showed partial response according to Response
Evaluation Criteria in Solid Tumors ("RECIST") 1.1 criteria in 33%
of patients previously treated with third-generation T790M-directed
EGFR inhibitors, including Tagrisso(R) (n=30). In patients who had
progressed after prior treatment with a first- or second-generation
EGFR inhibitor, 61% of T790M mutation negative patients (n=23) had
a partial response, while 55% of T790M mutation positive patients
(n=11) had a partial response.
In those patients where MET-positive status was determined
centrally, preliminary data showed partial response in 28% of
patients previously treated with T790M-directed EGFR inhibitors
(n=25). In patients who had progressed after prior treatment with a
first- or second-generation EGFR inhibitor, 53% of T790M mutation
negative patients (n=15) had a partial response, while 57% of T790M
mutation positive patients (n=7) had a partial response.
The presentation will be available at
www.chi-med.com/ph2-savo-plus-tagrisso-nsclc/.
Preliminary data for Savolitinib in Combination with Iressa(R)[
[2](])
Data from the Phase Ib/II proof-of-concept trial assessing
savolitinib in combination with Iressa(R) in patients in China with
EGFRm advanced NSCLC with centrally confirmed MET-amplification who
had progressed following EGFR inhibitor therapy were also reported.
The most common AEs independent of causality in 51 patients treated
were vomiting (39%), increased alanine aminotransferase (ALT)
(37%), increased aspartate aminotransferase (AST) (35%), nausea
(35%), and rash (35%). These results were consistent with the known
safety profiles of savolitinib and Iressa(R) .
Preliminary results showed that 31% of patients had a partial
response according to RECIST 1.1 criteria, of which 52% of T790M
negative patients (n=23) and 9% of T790M positive patients (n=23)
achieved a partial response.
The presentation will be available at
www.chi-med.com/ph2-savolitinib-plus-iressa-nsclc/.
Mr. Christian Hogg, Chief Executive Officer of Chi-Med, said,
"MET-amplification impacts a meaningful proportion of patients with
EGFRm NSCLC who experience disease progression following treatment
with a tyrosine kinase inhibitor in the first or second-line
setting. Among patients with this difficult-to-treat resistance
mechanism, there is a clear unmet medical need."
About Savolitinib
Savolitinib (AZD6094/HMPL-504) is a potential first-in-class
selective 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
other selective c-MET inhibitors, such as renal toxicity.
Savolitinib was discovered by Chi-Med and is being developed in
collaboration with AstraZeneca. Savolitinib is currently being
studied in multiple tumor types worldwide including kidney, lung
and gastric cancers, both as a monotherapy and in combination with
other targeted and immunotherapy 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.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines, primarily for the treatment of diseases in
three main therapy areas - Oncology, Cardiovascular & Metabolic
Diseases and Respiratory. The Company also is selectively active in
the areas of autoimmunity, neuroscience and infection. AstraZeneca
operates in over 100 countries and its innovative medicines are
used by millions of patients worldwide.
For more information, please visit www.astrazeneca.com and on
Twitter @AstraZeneca.
Tagrisso(R) and Iressa(R) are trademarks of the AstraZeneca PLC
group of companies.
Forward-Looking Statements
This announcement 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
savolitinib, plans to initiate clinical studies for 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 the drug
candidate 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 savolitinib for a targeted indication and
the sufficiency of funding. In addition, as certain studies rely on
the use of Tagrisso(R) or Iressa(R) as a combination therapeutic
with savolitinib, such risks and uncertainties include assumptions
regarding the safety, efficacy, supply and continued regulatory
approval of Iressa(R) and Tagrisso(R) . 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 announcement, whether as a result of
new information, future events or circumstances or otherwise.
Inside Information
This announcement contains inside information for the purposes
of Article 7 of Regulation (EU) No 596/2014.
CONTACTS
Investor Enquiries
Mark Lee, Senior Vice President, Corporate Finance
& Development +852 2121 8200
U.K. & International Media Enquiries
Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile) anthony.carlisle@cdrconsultancy.co.uk
U.S. Based Media Enquiries
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Susan Duffy, BMC Communications +1 (917) 499 8887 (Mobile) sduffy@bmccommunications.com
Investor Relations
Matt Beck, The Trout Group +1 (917) 415 1750 (Mobile) mbeck@troutgroup.com
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile) david.dible@citigatedr.co.uk
Panmure Gordon (UK) Limited
Richard Gray / Andrew Potts +44 (20) 7886 2500
References
[1] Ahn M-J, et al. TATTON Phase Ib Expansion Cohort:
Osimertinib Plus Savolitinib for Patients with EGFR-mutant
MET-amplified NSCLC After Progression on Prior EGFR-TKI. Abstract
#8985. Presented at the World Lung Cancer Congress 2017, Yokohama,
Japan, 15-18 October 2017.
[2] Yang J-J, et al. A Phase Ib Trial of Savolitinib Plus
Gefitinib for Patients with EGFR-mutant MET-amplified Advanced
NSCLC. Abstract #8995. Presented at the World Lung Cancer Congress
2017, Yokohama, Japan, 15-18 October 2017.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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