Chi-Med Initiates a Phase II Study of Savolitinib in Pulmonary Sarcomatoid Carcinoma
February 20 2017 - 1:14AM
Business Wire
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM)
today announces that a Phase II study of savolitinib has been
initiated in locally advanced or metastatic pulmonary sarcomatoid
carcinoma (“PSC”) in China. Savolitinib is a highly selective and
potent oral c-Met inhibitor with global first-in-class potential.
The first drug dose was administered on February 10, 2017.
This Phase II study is a multi-center, single-arm, open-label
study to evaluate the efficacy and safety of savolitinib as a
monotherapy in treating locally advanced or metastatic PSC patients
harboring mesenchymal epithelial transition (“Met”) gene
alterations. The primary endpoint is objective response rate (ORR),
with secondary endpoints including progression free survival (PFS),
disease control rate (DCR), duration of response (DoR), overall
survival (OS) and safety. Additional details about this study can
be found at clinicaltrials.gov, using identifier NCT02897479.
About PSC and Met gene alterations
PSC is a rare subset of poorly differentiated non-small cell
lung cancer (“NSCLC”). Containing a component with sarcoma-like
(spindle and/or giant cell) features, PSC accounts for
approximately 0.4% of all cases of lung cancer in the US, according
to the Surveillance, Epidemiology and End Results database. These
tumors are highly aggressive with outcomes significantly worse than
other forms of NSCLC, and are more resistant to conventional
chemotherapies1,2. There is no approved targeted therapy for this
fatal disease.
The sarcomatoid component of some PSC tumors is believed to
derive from carcinoma cells through the activation of Met. Met gene
exon 14 skipping has been reported as one of the major genetic
alterations in PSC, acting as a negative control in Met signaling.
This genetic alteration has been found in approximately 20-30% of
PSC patients3. As such, a highly selective c-Met inhibitor may
provide clinically meaningful benefit to patients with PSC.
About Savolitinib
Savolitinib 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.
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 US 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 in PSC, 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 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. 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
US 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.
1 S. Yendamuri et al; Outcomes of sarcomatoid carcinoma of the
lung: A Surveillance, Epidemiology, and End Results database
analysis. Surgery 2012 152(3) 397-402.
2 T Vieira et al; Efficacy of First-Line Chemotherapy in
Patients with Advanced Lung Sarcomatoid Carcinoma. J Thorac Oncol
2013 8(12) 1574-7.
3 J. Tong et al; MET Amplification and Exon 14 Splice Site
Mutation Define Unique Molecular Subgroups of Non–Small Cell Lung
Carcinoma with Poor Prognosis. Clin Cancer Res 2016 22(12)
3048-56.
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