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Hutchison China Meditech Limited
14 January 2021
Press Release
Chi-Med Highlights Savolitinib Clinical Data to be Presented at
Virtual WCLC
Hong Kong, Shanghai, & Florham Park, NJ: Thursday, January
14, 2021: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announces that the final analysis of savolitinib in
Phase Ib TATTON study Parts B and D will be presented at the
upcoming virtual 2020 World Conference on Lung Cancer (WCLC 2020),
taking place on January 28-31, 2021, virtually.
Further details of the featured poster presentation are as
follows:
Title: Osimertinib + savolitinib in patients with EGFRm MET-amplified/overexpressed
NSCLC: Phase Ib TATTON Parts B and D final analysis
Lead Author: Ji-Youn Han, Center for Lung Cancer, National Cancer
Center, Goyang, Republic of Korea
Session: FP14 - Targeted Therapy - Clinically Focused
Abstract # #FP14.03 / Link
/ Link:
A vailability Thursday, January 28, 2021 (from midnight Singapore
Date: time)
About Savolitinib
Savolitinib is an oral, potent, and highly selective small
molecule inhibitor of MET, a receptor tyrosine kinase which has
been shown to function abnormally in many types of solid tumors
promoting tumor growth, angiogenesis, and metastasis. Savolitinib
has been studied in over 1,000 patients to date. In clinical
studies, it has shown promising clinical efficacy in patients with
MET gene alterations in multiple tumor types with an acceptable
safety profile.
In 2011, Chi-Med entered into a global licensing and joint
development and commercialization agreement with AstraZeneca PLC
(LSE/STO/NYSE: AZN) for savolitinib. Savolitinib's global
development plan includes non-small cell lung cancer ("NSCLC") and
kidney cancer, and additional MET-driven tumors are being
explored.
Savolitinib development in NSCLC:
Phase II in MET Exon 14 alteration NSCLC ( NCT02897479 ) - In
May 2020, data from an ongoing open-label, Phase II registration
study was presented as part of the American Society of Clinical
Oncology 2020 Virtual Scientific Program ("ASCO 2020"). In patients
with MET Exon 14 skipping alteration NSCLC in the efficacy
evaluable population, savolitinib demonstrated a 49.2% objective
response rate ("ORR"), a 93.4% disease control rate (DCR) and a 9.6
months interim duration of response ("DoR"). 36% of patients in the
study have pulmonary sarcomatoid carcinoma (PSC), an aggressive
subtype of NSCLC. Data were not yet mature for DoR,
progression-free survival (PFS) or overall survival ("OS").
Clinical data indicated an acceptable safety profile, with a low
adverse event (AE) related discontinuations rate of 14.3%. This
data supported the China new drug application ("NDA") acceptance in
May 2020.
SAVANNAH Phase II study of savolitinib in combination with
Tagrisso(R) in patients who have progressed following Tagrisso(R)
due to MET amplification or overexpression ( NCT03778229 ) - The
SAVANNAH study is a single-arm, open-label study in epidermal
growth factor receptor ("EGFR") mutation positive NSCLC patients
with MET amplified/overexpressed tumors following progression after
treatment with Tagrisso(R) , an EGFR-tyrosine kinase inhibitor
owned by AstraZeneca.
Savolitinib development in kidney cancer:
MET-driven papillary renal cell carcinoma ("RCC") ( NCT03091192
) - In May 2020, data from 60 patients in the SAVOIR global study
of savolitinib monotherapy compared with sunitinib monotherapy in
MET-driven papillary RCC was presented at ASCO 2020. Savolitinib
demonstrated encouraging activity, including an ORR of 27% versus
7% for sunitinib, with no savolitinib responding patients with
disease progression at data cut-off, and an encouraging OS hazard
ratio of 0.51 (95% CI: 0.21-1.17; p=0.110) with median not reached
at data cut-off.
CALYPSO Phase II of savolitinib in combination with Imfinzi(R)
PD-L1 inhibitor in RCC ( NCT02819596 ) - The CALYPSO study is an
investigator initiated open-label Phase I/II study of savolitinib
in combination with Imfinzi(R) , a PD-L1 antibody owned by
AstraZeneca. The study is evaluating the safety and efficacy of the
savolitinib/Imfinzi(R) combination in patients with papillary RCC
and clear cell RCC.
Based on these data, AstraZeneca and Chi-Med are actively
evaluating the opportunity to progress clinical work in papillary
RCC for savolitinib.
Savolitinib development in other cancer indications:
Savolitinib opportunities are also continuing to be explored in
multiple other MET-driven tumor settings via investigator-initiated
studies including gastric cancer and colorectal cancer.
About Chi-Med
Chi-Med (Nasdaq/AIM: HCM) is an innovative 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 therapeutic
potential of savolitinib for the treatment of patients with NSCLC,
the further clinical development of savolitinib in this and other
indications, its expectations as to whether clinical studies of
savolitinib 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 the sufficiency of its
data to support NDA approval of savolitinib for the treatment of
patients with NSCLC in China, its potential to gain expeditious
approvals for savolitinib in other jurisdictions such as the U.S.,
E.U. or Japan, the safety profile of savolitinib, the potential for
savolitinib to become a new standard of care for NSCLC patients,
its ability to implement and complete its further clinical
development plans for savolitinib, its potential commercial launch
of savolitinib in China and other jurisdictions, 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 Tagrisso(R) and Imfinzi(R) as
combination therapeutics with savolitinib, such risks and
uncertainties include assumptions regarding the safety, efficacy,
supply and continued regulatory approval of Tagrisso(R) and
Imfinzi(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 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
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