Chi-Med Announces NDA Acceptance in China for Savolitinib in the Treatment of Non-Small Cell Lung Cancer with MET Exon 14 S...
May 29 2020 - 2:00AM
Hutchison China MediTech Limited (“Chi-Med”) (Nasdaq/AIM: HCM)
today announced that the New Drug Application (“NDA”) for
savolitinib for the treatment of non-small cell lung cancer
(“NSCLC”) with MET Exon 14 skipping mutations has been accepted for
review by the China National Medical Products Administration
(NMPA).
The NDA is supported by data from an open-label,
Phase II registration study. Interim data were presented on
the first 50 treated patients at the Chinese Society of Clinical
Oncology Annual Meeting in September 2019. An updated
analysis with 70 patients in the study will be presented by
Professor Shun Lu as part of the American Society of Clinical
Oncology (“ASCO”) 2020 Virtual Scientific Meeting, available on May
29, 2020 at 8:00 a.m. Eastern Time (“Phase II Study of Savolitinib
in Patients with Pulmonary Sarcomatoid Carcinoma and Other Types of
Non-Small Cell Lung Cancer Harboring MET Exon 14 Skipping
Mutations”, abstract #9519).
“With today’s NDA acceptance, savolitinib is one
step closer to benefitting a specific group of NSCLC patients who
have limited treatment options today and we are very proud of that.
After many years of collaboration with AstraZeneca, we hope that
this NDA is the first of many globally for savolitinib.” Mr
Christian Hogg, Chief Executive Officer of Chi-Med,
commented.
It is estimated that 2-3% of NSCLC patients have
MET Exon 14 skipping mutations, which predicts poor
prognosis.1 Annual incidence of lung cancer in China
accounted for 37.0% of the world’s annual incidence of lung cancer
in 2018.2
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.
About Savolitinib
Savolitinib is a small molecule inhibitor of
MET, a receptor tyrosine kinase 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. In
clinical studies to date, involving over 1,000 patients,
savolitinib has shown promising clinical efficacy in patients with
MET gene alterations in multiple tumor types with an acceptable
safety profile.
Savolitinib in NSCLC:
Phase II in MET Exon 14 deletion NSCLC
(NCT02897479) – NDA accepted and data to be presented at ASCO
2020.
SAVANNAH Phase II study of savolitinib in
combination with Tagrisso® in patients who have progressed
following Tagrisso® due to MET amplification (NCT03778229) – The
SAVANNAH study is a single-arm, open-label study in epidermal
growth factor receptor (EGFR) mutation positive NSCLC patients
following first- or second-line Tagrisso® therapy.
Savolitinib in kidney
cancer:
CALYPSO Phase II of savolitinib in combination
with Imfinzi® PD-L1 inhibitor in renal cell carcinoma (“RCC”)
(NCT02819596) – The CALYPSO study is an investigator initiated
open-label Phase I/II study of savolitinib in combination with
Imfinzi®, an anti-PD-L1 antibody owned by AstraZeneca. The
study is evaluating the safety and efficacy of the
savolitinib/Imfinzi® combination in patients with papillary RCC
(“PRCC”) and clear cell RCC.
SAVOIR Phase III in MET-positive PRCC
(NCT03091192) – In December 2018, enrollment was terminated in
SAVOIR, a global Phase III registration study of savolitinib
monotherapy compared with sunitinib monotherapy in MET-positive
PRCC. The early termination was driven by factors external to
the SAVOIR study. Data from the approximately 60 patients
randomized in SAVOIR prior to termination matured during 2019 and
will be presented by Professor Toni K. Choueiri at ASCO 2020
Virtual Scientific meeting in an oral abstract session, available
on May 29, 2020 at 8:00 a.m. Eastern Time (“SAVOIR: A Phase III
Study of Savolitinib Versus Sunitinib in Patients with MET-driven
Papillary Renal Cell Carcinoma”, abstract #5002). Based on these
data, AstraZeneca and Chi-Med are actively evaluating the
opportunity to restart clinical work in PRCC for monotherapy
savolitinib.
Savolitinib in other cancer
indications:
Investigator-initiated studies of savolitinib
have been undertaken in gastric cancer, prostate 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 eight 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 9783 6894
(Mobile), yzhou@brunswickgroup.com |
|
|
Nominated Advisor |
|
Freddy Crossley / Atholl Tweedie, Panmure Gordon
(UK) Limited |
+44 (20) 7886 2500 |
____________________
1Awad 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.
2 Global Cancer Observatory.
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