TIDMHCM
Hutchison China Meditech Limited
18 September 2019
Press Release
Chi-Med Highlights Oral Presentations at 2019 CSCO Annual
Meeting
London: Wednesday, September 18, 2019: Hutchison China MediTech
Limited ("Chi-Med") (AIM/Nasdaq: HCM) shares additional analyses
from three completed and ongoing clinical studies of fruquintinib
and savolitinib at the 22(nd) Annual Meeting of the Chinese Society
of Clinical Oncology ("CSCO") on September 18 to 22, 2019 in
Xiamen, China.
Fruquintinib (Elunate(R) ): Two subgroup analyses will be
presented from the FRESCO study, a randomized, double-blind,
placebo-controlled, multi-center, Phase III study of fruquintinib
efficacy and safety in third-line or above colorectal cancer
("CRC") patients.
Presentation Title Subgroup Analysis of Patients With Metastatic Colorectal Cancer Treated With Fruquintinib
1: in the FRESCO Trial Who Had Liver Metastasis
Presenting Author: Shukui Qin, Nanjing Chinese Medicine University Affiliated Bayi Hospital
Other Authors: Jin Li, Rui-Hua Xu, Lin Shen, Jianming Xu, Yuxian Bai, Yanhong Deng, Lei Yang, Zhen-dong Chen,
Haijun Zhong, Hongming Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianfeng Zhou, Nong Xu,
Tianshu Liu, Dong Ma, Changping Wu, Ying Cheng, Donghui Chen, Wei Li, Sanyuan Sun, Zhuang
Yu, Peiguo Cao, Haihui Chen, Jiejun Wang, Shubin Wang, Hongbing Wang, Xia Qin, Ning Wang,
Bin Zhang, Songhua Fan, Xiaojun Guo, Mengye Peng
Abstract #: 5278
Session: Plenary session
Date: Thursday, September 19, 2019
Time: 10:45 AM
The development of metastases is the main cause of death in
patients with CRC, and about 70% of patients with CRC develop liver
metastases during the course of their disease[1](,[2]) . Abstract
5278 is a subgroup analysis to determine the benefit of
fruquintinib to patients with liver metastases on study entry.
Liver metastases were present in 69% of the patients recruited into
the study.
Fruquintinib demonstrated a statistically significant increase
in overall survival ("OS"; 8.61 vs. 5.98 months; hazard ratio =
0.59, 95% CI: 0.45-0.77, p<0.001) and progression-free survival
("PFS"; 3.71 vs 1.84 months; hazard ratio = 0.22, 95% CI:
0.17-0.30, p<0.001) as compared with placebo in CRC patients
with liver metastasis, while the hepatotoxicity of fruquintinib was
comparable with placebo in CRC patients with liver metastasis.
Presentation Title Association Between Hand-Foot Skin Reaction and Survival Benefit of Fruquintinib in FRESCO
2: Trial
Presenting Author: Yuxian Bai, Harbin Medical University Cancer Hospital
Other Authors: Jin Li, Shukui Qin, Yanhong Deng, Lei Yang, Rui-hua Xu, Zhendong Chen, Haijun Zhong, Hongming
Pan, Weijian Guo, Yongqian Shu, Ying Yuan, Jianming Xu, Lin Shen, Ning Wang, Chao Zhu, Songhua
Fan, Wei Gong, Wei Wang
Abstract #: 5517
Session: CSCO CRC Expert Committee, CRC standardized treatment and MDT
Date: Saturday, September 21, 2019
Time: 11:17 AM
Abstract 5517 is a subgroup analysis of the FRESCO results to
explore whether patients in the fruquintinib group of the study
experiencing hand-foot skin reaction ("HFSR") saw a greater
survival benefit. These reactions of any grade developed in 52% of
patients who completed at least one cycle of fruquintinib
treatment.
The analysis indicated that patients who reported HFSR had a
greater survival benefit from fruquintinib, showing statistically
significant benefit in both median OS (11.24 vs. 7.54 months;
hazard ratio = 0.57, 95% CI: 0.42-0.78; p<0.001) and median PFS
(5.49 vs 3.48 months; hazard ratio = 0.70, 95% CI: 0.54-0.91;
p=0.008) compared to those that did not report HFSR.
Results of the FRESCO study were initially presented in an oral
presentation at the American Society of Clinical Oncology Annual
Meeting on June 5, 2017 and published in The Journal of the
American Medical Association, JAMA, in June 2018
(clinicaltrials.gov identifier: NCT02314819).
Fruquintinib is a highly selective and potent oral inhibitor of
vascular endothelial growth factor receptor ("VEGFR") 1/2/3. VEGFR
inhibitors play a pivotal role in blocking tumor-related
angiogenesis, cutting off the blood supply that a tumor needs to
grow rapidly. Fruquintinib has been designed to be a global
best-in-class VEGFR inhibitor for many types of solid tumors. It
was designed to improve kinase selectivity in comparison to other
approved small molecule tyrosine kinase inhibitors, to minimize
off-target toxicities, improve tolerability and provide more
consistent target coverage. Chi-Med retains all rights to
fruquintinib outside of China and is partnered with Eli Lilly and
Company in China.
Savolitinib:
Presentation Title: Phase II Study of Savolitinib in Patients with NSCLC Harboring MET Exon 14 Skipping Mutations:
Preliminary Efficacy and Safety Results
Presenting Author: Shun Lu, Shanghai Chest Hospital, Shanghai Jiao Tong University
Other Authors: Jian Fang, Xingya Li, Jianying Zhou, Lejie Cao, Ying Cheng, Liyan Jiang, Qisen Guo, Zongan
Liang, Yuan Chen, Helong Zhang, Nong Yang, Hua Xu, Xin Zhang, Biao Wu, Jianhua Shi, Zhigang
Han, Jianjin Huang, Zhixiong Yang, Xiaodong Zhang, Gongyan Chen, Yanping Hu, Jingxun Wu, Shan
Zeng, Sanyuan Sun, Longzhen Zhang, Rui Ma, Xiaorong Dong, Di Zhang, Jing Li, Linfang Wang,
Yongxin Ren, Weiguo Su
Abstract #: 5707
Session: CSCO NSCLC Expert Committee, SCLC Expert Committee, MDT for liver cancer with ALK and other
rare mutations
Date: Friday, September 20, 2019
Time: 4:40 PM
Abstract 5707 highlights updated preliminary efficacy and safety
results from the ongoing China Phase II study of savolitinib
monotherapy in NSCLC patients with mesenchymal epithelial
transition receptor ("MET") Exon 14 skipping mutations who have
failed prior systemic therapy or are unable to receive
chemotherapy.
Savolitinib showed promising antitumor activity in this
population with rapid and durable tumor response and disease
control, anti-tumor activity in brain metastasis, and a generally
tolerable safety profile with mostly grade 1 or 2 related treatment
emergent adverse events. The study continues to enroll patients.
Earlier results of this study were first presented on March 31,
2019 at the American Association of Cancer Research (AACR) Annual
Meeting 2019 (clinicaltrials.gov identifier: NCT02897479).
Savolitinib is a potent and selective inhibitor of MET, an
enzyme which has been shown to function abnormally in many types of
solid tumors. In clinical studies to date in over 1,000 patients
globally, savolitinib has shown promising signs of clinical
efficacy in patients with MET gene alterations in lung cancer,
kidney cancer, and gastric cancer with an acceptable safety
profile. Chi-Med is currently testing savolitinib in global
partnership with AstraZeneca, both as a monotherapy and in
combinations.
About Chi-Med
Chi-Med (AIM/Nasdaq: HCM) is an innovative biopharmaceutical
company which researches, develops, manufactures and markets
pharmaceutical products. Its Innovation Platform, Hutchison
MediPharma, has about 440 scientists and staff focusing on
discovering, developing and commercializing targeted therapeutics
and immunotherapies in oncology and autoimmune diseases. It has a
portfolio of eight cancer drug candidates currently in clinical
studies around the world. Chi-Med's Commercial Platform
manufactures, markets, and distributes prescription drugs and
consumer health products, covering an extensive network of
hospitals across China.
Chi-Med is headquartered in Hong Kong and is dual-listed on the
AIM market of the London Stock Exchange and the Nasdaq Global
Select Market. 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 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, including
as a combination therapies, 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. 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
David Dible, Citigate Dewe Rogerson +44 7967 566 919 (Mobile)
david.dible@citigatedewerogerson.com
Xuan Yang, Solebury Trout +1 (415) 971 9412 (Mobile)
xyang@troutgroup.com
Media Enquiries
UK & Europe - Anthony Carlisle, Citigate Dewe Rogerson +44 7973 611 888 (Mobile)
anthony.carlisle@cdrconsultancy.co.uk
Americas - Brad Miles, Solebury Trout +1 (917) 570 7340 (Mobile)
bmiles@troutgroup.com
Hong Kong & Asia ex-China - Joseph Chi Lo, Brunswick +852 9850 5033 (Mobile)
jlo@brunswickgroup.com
- Zhou Yi, Brunswick +852 9783 6894 (Mobile)
yzhou@brunswickgroup.com
Mainland China - Sam Shen, Edelman +86 136 7179 1029 (Mobile)
sam.shen@edelman.com
Nominated Advisor
Richard Gray / Atholl Tweedie, Panmure Gordon (UK) Limited +44 (20) 7886 2500
[1] van de Velde CJH. Treatment of liver metastases of
colorectal cancer. Annals of Oncology, Volume 16 (Supplement 2):
ii144 - ii149, June 2005. doi:10.1093/annonc/mdi702.
[2] Welch JP & Donaldson GA. The clinical correlation of an
autopsy study of recurrent colorectal cancer. Annals of Surgery,
189(4), 496-502, 1979. doi:10.1097/00000658-197904000-00027.
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END
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