TIDMHCM
Hutchison China Meditech Limited
28 July 2020
Press Release
Chi-Med's NDA for Savolitinib in Non-Small Cell Lung Cancer
Granted Priority Review in China
Hong Kong, Shanghai & Florham Park, NJ: Tuesday, July 28,
2020: Hutchison China MediTech Limited ("Chi-Med") (Nasdaq/AIM:
HCM) today announced that the China National Medical Products
Administration ("NMPA") has granted Priority Review status to the
New Drug Application ("NDA") for savolitinib for the treatment of
non-small cell lung cancer ("NSCLC") with MET Exon 14 skipping
mutations. This is the first NDA filing for savolitinib globally
and first for a selective MET inhibitor in China.
With over 774,000 new cases every year, China accounted for 37%
of the world's annual incidence of lung cancer in 2018.[1]
Approximately 80-85% of lung cancer cases are NSCLC.[2] It is
estimated that 2-3% of NSCLC patients have MET Exon 14 skipping
mutations; these mutations lead to poor prognosis.[3] The annual
incidence of MET Exon 14 skipping mutation NSCLC is estimated to be
12,000 to 20,000 in China.
About Priority Review in China
The NMPA's Priority Review procedure encourages research and
development of potential new medicines with clear clinical value,
medicines or vaccines that address urgent clinical needs, as well
as medicines that address serious infectious diseases, certain rare
diseases, and select pediatric conditions or formulations. A
potential new medicine may have clear clinical value if it is being
developed for serious conditions that are life threatening,
debilitating, or impact quality of life. NDAs undergoing Priority
Review would receive preferential allocation of NMPA resources
during the review process.[4]
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 (LSE,
STO, NYSE: AZN) for savolitinib. Savolitinib's global development
plan includes NSCLC and kidney cancer, and additional MET-driven
tumors are being explored.
Savolitinib development in NSCLC:
Phase II in MET Exon 14 mutation 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 mutation 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
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 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. Based on these data, AstraZeneca and Chi-Med are
actively evaluating the opportunity to progress clinical work in
papillary RCC for monotherapy savolitinib.
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.
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. 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
[1] Global Cancer Observatory. China Fact Sheet.
gco.iarc.fr/today/data/factsheets/populations/160-china-fact-sheets.pdf.
[2] American Cancer Society.
www.cancer.org/cancer/lung-cancer/about/what-is.html.
[3] Aw ad M et al. "MET Exon 14 Mutations in Non-Small-Cell Lung
Cancer Are Associated With Advanced Age and Stage-Dependent MET
Genomic Amplification and c-Met Overexpression." Journal of
Clinical Oncology 2016;34(7):721-730. doi: 10.1200/JCO.2015.63.4600
.
[4] National Medical Products Administration, "Drug Marketing
Authorization Priority Review Process."
http://www.nmpa.gov.cn/WS04/CL2138/378606.html .
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END
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