- Following its initial approval for the treatment of
relapsed/refractory multiple myeloma (R/R MM), XPOVIO®
has now received approval as a monotherapy for the treatment of
adult patients with relapsed/refractory diffuse large B-cell
lymphoma (R/R DLBCL) marking the second approved indication of
XPOVIO® in China.
- Results from the
registrational SEARCH study in China showed that the overall response rate
(ORR) among the 60 Chinese patients treated with XPOVIO®
met the study's prespecified primary endpoint.
-
XPOVIO® is an oral drug with a novel mechanism of
action. Antengene is currently developing multiple combination
regimens of XPOVIO® for the treatment of various
indications including myelofibrosis (MF), T-cell non-Hodgkin's
lymphoma (T-NHL), and endometrial cancer.
-
XPOVIO® has been approved for health insurance coverage
in the mainland of China,
Australia, Singapore and South
Korea. Furthermore, Antengene has submitted new drug
applications (NDAs) for XPOVIO® in other ASEAN markets
including Thailand, Malaysia and Indonesia. Approvals in these markets are
anticipated in the second half of 2024.
SHANGHAI and HONG
KONG, July 5, 2024 /PRNewswire/ -- Antengene
Corporation Limited ("Antengene", SEHK: 6996.HK), a leading
innovative, commercial-stage global biopharmaceutical company
dedicated to discovering, developing and commercializing
first-in-class and/or best-in-class medicines for cancer, today
announced that the China National Medical Products
Administration (NMPA) has approved a new indication of
XPOVIO® (selinexor) as a monotherapy for the
treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (R/R DLBCL).
A Novel Therapy Bringing Long-awaited Clinical Breakthrough
to the Treatment of R/R DLBCL
DLBCL is one of the most common subtypes of non-Hodgkin lymphoma
(NHL) in adults and is highly heterogeneous malignancy in both
clinical manifestations and prognosis. The current standard
treatment, immunotherapy, offers patients with DLBCL a five-year
progression-free survival rate of 60%-65% and curative outcomes for
40%-50% of treated patients. However, 10%-15% of DLBCL patients do
not respond to standard first-line treatment, and 20%-25%
experience relapses after achieving initial responses, leading to a
poor prognosis and enormous unmet clinical needs.
The Clinically Validated Efficacy and Convenience of Oral
Administration of Selinexor Offer Benefits to a Broad Spectrum of
Patients
The approval for the new indication was supported by
data from the registrational SEARCH study in
China. Results from the study, which enrolled a total of
60 Chinese patients with DLBCL, showed that patients treated in the
trial achieved a central radiological review assessed overall
response rate (ORR) meeting the pre-specified primary endpoint. The
SEARCH study demonstrated clear efficacy of orally-administered
selinexor monotherapy in Chinese patients, exhibiting significant
response rates, durable responses, long survival.
Prof. Jun Zhu, principal
investigator of the SEARCH study from Peking University affiliated
Beijing Cancer Hospital, said, "DLBCL is the most common
subtype of NHL in adults and accounts for 40% of all NHL cases in
China. The incidence of NHL has
been steadily rising year over year, while patients with third- and
later-lines relapsed or refractory disease lack effective and
convenient therapies. As a nuclear export protein inhibitor with a
novel mechanism of action (MOA), selinexor offers patients a new
treatment option that is efficacious and easy to use, with oral
availability that can reduce hospitalization and financial burden
on patients by allowing them to receive treatment at home. Overall,
the approval for this new indication of selinexor is indeed a great
news for Chinese patients with R/R DLBCL."
Approved in 40+ Markets Globally with Expanding Insurance
Coverage Across APAC
With a novel mechanism of action, XPOVIO® is the
world's first approved orally-available, selective XPO1 inhibitor.
XPOVIO® has a global commercial presence with approvals
in over 40 countries and regions. To date, XPOVIO® has
already been included for health insurance coverage in the mainland
of China, Australia, Singapore and South
Korea. Antengene has also submitted the NDAs in additional
ASEAN markets, including Thailand,
Malaysia and Indonesia, where approvals are expected in the
H2 of 2024.
About XPOVIO® (selinexor)
XPOVIO® is the world's first approved
orally-available, selective inhibitor of the nuclear export protein
XPO1. It offers a novel mechanism of action, synergistic
effects in combination regimens, fast onset of action, and durable
responses.
By blocking the nuclear export protein XPO1, XPOVIO®
can promote the intranuclear accumulation and activation of tumor
suppressor proteins and growth regulating proteins, and
down-regulate the levels of multiple oncogenic proteins.
XPOVIO® delivers its antitumor effects through three
mechanistic pathways: 1) exerting antitumor effects by inducing the
intranuclear accumulation of tumor suppressor proteins; 2) reducing
the level of oncogenic proteins in the cytoplasm by inducing the
intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone
sensitivity by activating the glucocorticoid receptors (GR)
pathway. To utilize its unique mechanism of actions,
XPOVIO® is being evaluated for use in multiple
combination regimens in a range of indications. At present,
Antengene is conducting multiple clinical studies of
XPOVIO® in the mainland of China for the treatment of relapsed/refractory
hematologic malignancies and solid tumors (3 of these studies are
being jointly conducted by Antengene and Karyopharm Therapeutics
Inc. [Nasdaq:KPTI]).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK:
6996.HK) is a leading commercial-stage R&D-driven global
biopharmaceutical company focused on the discovery, development,
manufacturing and commercialization of innovative
first-in-class/best-in-class therapeutics for the treatment of
hematologic malignancies and solid tumors, in realizing its vision
of "Treating Patients Beyond Borders".
Since 2017, Antengene has built a pipeline of 9 oncology assets
at various stages going from clinical to commercial, including 6
with global rights, and 3 with rights for the APAC region. To date,
Antengene has obtained 29 investigational new drug (IND) approvals
in the U.S. and Asia, and
submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for
XPOVIO® (selinexor) already approved in Mainland of
China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia.
Forward-looking statements
The forward-looking statements made in this article relate only
to the events or information as of the date on which the statements
are made in this article. Except as required by law, we undertake
no obligation to update or revise publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise, after the date on which the statements are made or to
reflect the occurrence of unanticipated events. You should read
this article completely and with the understanding that our actual
future results or performance may be materially different from what
we expect. In this article, statements of, or references to, our
intentions or those of any of our Directors or our Company are made
as of the date of this article. Any of these intentions may alter
in light of future development. For a further discussion of these
and other factors that could cause future results to differ
materially from any forward-looking statement, please see the other
risks and uncertainties described in the Company's Annual Report
for the year ended December 31, 2023,
and the documents subsequently submitted to the Hong Kong Stock
Exchange.
For more information, please contact:
Investor Contacts:
Donald Lung
E-mail: Donald.Lung@antengene.com
Mobile: +86 18420672158
PR Contacts:
Peter Qian
E-mail: Peter.Qian@antengene.com
Mobile: +86 13062747000
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