DJ EQS-News: Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has received FDA Approval of XPOVIO(R) (Selinexor) as a Treatment for Patients with Multiple Myeloma After At Least One Prior Therapy
EQS-News / 21/12/2020 / 15:21 UTC+8
Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc., has
received FDA Approval of XPOVIO(R) (Selinexor) as a Treatment for Patients
with Multiple Myeloma After At Least One Prior Therapy
--Oral XPOVIO(R) Approval as Combination Therapy in Patients with Multiple
Myeloma After At Least One Prior Therapy Significantly Expands the XPOVIO(R)
Addressable Patient Population -
-- Oral XPOVIO(R) is Now the Only Approved Multiple Myeloma Drug Indicated
as Part of a Once-Weekly Bortezomib Combination Regimen -
-- First Multiple Myeloma Drug with a New Mechanism of Action Approved by
the FDA in the Second-Line Setting Since 2016 -
-- FDA Approval Comes Approximately Three Months Ahead of Target PDUFA Date
-
Shanghai and Hong Kong, PRC, December 21, 2020 -- Antengene Corporation
Limited ("Antengene", SEHK: 6996.HK) today announced that the U.S. Food and
Drug Administration (FDA) has approved the supplemental New Drug Application
(sNDA) submitted by its partner Karyopharm Therapeutics Inc. (Nasdaq: KPTI)
for oral XPOVIO(R) (selinexor, ATG-010), a first-in-class, oral Selective
Inhibitor of Nuclear Export (SINE) medicine, in combination with bortezomib
and dexamethasone for the treatment of adult patients with multiple myeloma
who have received at least one prior therapy. This indication was approved
three months ahead of its March Prescription Drug User Fee Act (PDUFA) date
based on the result of a confirmatory Phase 3 BOSTON study.
XPOVIO(R) was previously approved under the FDA's Accelerated Approval
Program for the treatment of adult patients with relapsed or refractory
multiple myeloma (rrMM) who have received at least four prior therapies and
whose disease is refractory to at least two proteasome inhibitors, at least
two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
XPOVIO(R), a first-in-class and only-in-class oral SINE compound, and now
the first and only drug approved by FDA for use in both multiple myeloma and
diffuse large B-cell lymphoma, discovered and developed by Karyopharm, is
currently being developed by Antengene, who has the exclusive development
and commercial rights in certain Asia-Pacific markets, including China. In
December 2020, National Comprehensive Cancer Network (NCCN(R)) added three
different XPOVIO(R) combination regimens to its Clinical Practice Guidelines
in Oncology (NCCN(R) Guidelines) for previously treated multiple myeloma.
Antengene has conducted two Phase 2 registrational clinical trials of
XPOVIO(R) in China for relapsed or refractory multiple myeloma (MARCH) and
for relapsed or refractory diffuse large B-cell lymphoma (SEARCH). A Phase 3
randomized, controlled, open-label and multicenter BENCH trial has also
received the IND approval from the National Medical Products Administration
(NMPA) in China. Antengene is working on making XPOVIO(R) commercially
available in Asia Pacific regions and has submitted the New Drug
Applications (NDAs) for XPOVIO(R) to the Health Sciences Authority (HSA) of
Singapore and the Australian Therapeutic Goods Administration (TGA) for
three indications, including the treatment of patients with multiple myeloma
who have received at least one prior therapy.
"This is the third approved indication for XPOVIO(R), highlighting its
potential of clinical application and broad market prospects. XPOVIO(R)
offers patients with rrMM and their physicians the first oral SINE compound
and makes more treatment options available to cancer patients with critical
unmet medical needs." Dr. Jay Mei, M.D., Ph.D., Founder, Chairman and CEO of
Antengene said, "We plan to launch XPOVIO(R) as soon as possible for the
treatment of patients with rrMM and rrDLBCL in APAC following regulatory
approvals, by leveraging our established commercial infrastructure and
seasoned international team."
About the Phase 3 BOSTON Study
The approval of XPOVIO(R) in combination with once-weekly bortezomib plus
low-dose dexamethasone (SVd) is supported by the results of the
multi-center, Phase 3, randomized study, which evaluated 402 adult patients
with relapsed or refractory multiple myeloma who had received one to three
prior lines of therapy. The study was designed to compare the efficacy,
safety and certain health-related quality of life parameters of once-weekly
XPOVIO(R) (selinexor) in combination with once-weekly bortezomib plus
low-dose dexamethasone (SVd) versus twice-weekly bortezomib plus
dexamethasone (Vd). The primary endpoint of the study was progression-free
survival (PFS) and key secondary endpoints included overall response rate
(ORR), rate of peripheral neuropathy, and others. Additionally, the BOSTON
study allowed for patients on the Vd control arm to crossover to the SVd arm
following objective (quantitative) progression of disease verified by an
Independent Review Committee (IRC). The BOSTON study was conducted at over
150 clinical sites internationally.
Although the study had one of the highest proportions of patients with
high-risk cytogenetics (50%) as compared with other bortezomib-based
studies in previously treated myeloma, the median PFS in the SVd arm was
13.9 months compared to 9.5 months in the Vd arm, representing a 4.4 month
increase in median PFS (hazard ratio [HR] of 0.70; p=0.0075). The SVd group
also demonstrated a significantly greater ORR compared to the Vd group
(76.4% vs. 62.3%, p=0.0012). Importantly, SVd therapy compared to Vd therapy
showed consistent PFS benefit and higher ORR across several important
subgroups.
In addition, the following results favored SVd therapy as compared to Vd
therapy:
* SVd therapy demonstrated a significantly higher rate of deep responses,
defined as >= Very Good Partial Response compared to Vd therapy (44.6% vs.
32.4%) as well as a longer median duration of response (20.3 months vs. 12.9
months). Additionally, 17% of patients on the SVd arm achieved a Complete
Response or a Stringent Complete Response as compared to 10% of patients
receiving Vd therapy. All responses were confirmed by an IRC.
* Peripheral neuropathy (PN) rates were significantly lower on SVd compared
to Vd (32% vs. 47%). In addition, PN rates >= Grade 2 were also
significantly lower in the SVd arm compared to Vd (21% vs. 34%).
The most common adverse reactions were cytopenias, along with
gastrointestinal and constitutional symptoms and were consistent with those
previously reported from other selinexor studies. Most adverse reactions
were manageable with dose modifications and/or standard supportive care. The
most common non-hematologic adverse reactions were nausea (50%), fatigue
(42%), decreased appetite (35%), and diarrhea (32%) and were mostly Grade 1
and 2 events. The most common Grade 3 and 4 adverse reactions were
thrombocytopenia (43%), lymphopenia (38%), anemia (17%), and fatigue (13%).
About XPOVIO(R) (selinexor, ATG-010)
XPOVIO(R) (selinexor, ATG-010), a first-in-class and only-in-class oral
selective inhibitor of nuclear export compound discovered and developed by
Karyopharm, is currently being developed by Antengene, who has the exclusive
development and commercial rights in certain Asia-Pacific markets, including
China. In July 2019, the US Food and Drug Administration (FDA) approved
Selinexor (XPOVIO(R)) in combination with low-dose dexamethasone for the
treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020
approved selinexor (XPOVIO(R)) as a single-agent for the treatment of
relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing
Authorization Application (MAA) has also been submitted to the European
Medicines Agency (EMA) with a request for conditional approval of selinexor
(XPOVIO(R)) in this same rrMM indication. On December 18, 2020, the
supplemental New Drug Application (sNDA) requesting an expansion of its
indication to include the treatment for patients with multiple myeloma after
at least one prior therapy was approved by the FDA. Selinexor (XPOVIO(R)) is
so far the first and only oral SINE compound approved by the FDA. Selinexor
(XPOVIO(R)) is also being evaluated in several other mid-and later-phase
clinical trials across multiple solid tumor indications, including
liposarcoma and endometrial cancer. In November 2020, at the Connective
Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's
partner, Karyopharm, presented positive results from the Phase 3 randomized,
double blind, placebo controlled, cross-over SEAL study evaluating single
agent, oral selinexor (XPOVIO(R)) versus matching placebo in patients with
liposarcoma. Karyopharm also recently announced that the ongoing Phase 3
SIENDO study of selinexor (XPOVIO(R)) in patients with endometrial cancer
passed planned interim futility analysis and that Data and Safety Monitoring
Board (DSMB) recommended the study should proceed as planned without any
modifications. Top-line SIENDO study results are expected in the second half
of 2021.
Antengene is conducting two registrational Phase 2 clinical trials of
selinexor (XPOVIO(R)) in China for relapsed refractory multiple myeloma
(MARCH) and for relapsed refractory diffuse large B-cell lymphoma (SEARCH),
and has initiated clinical trials for high prevalence cancer types in the
Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell
lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading
clinical-stage Asia-Pacific biopharmaceutical company focused on innovative
oncology medicines. Antengene aims to provide the most advanced anti-cancer
drugs to patients in China, the Asia Pacific Region and around the world.
Since its establishment, Antengene has built a pipeline of 12 clinical and
pre-clinical stage assets and obtained 11 investigational new drug approvals
in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond
Borders". Antengene aims to address significant unmet medical needs by
discovering, developing and commercializing first-in-class/best-in-class
therapeutics.
Forward-looking Statements
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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
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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.
*XPOVIO(R) is a registered trademark of Karyopharm Therapeutics Inc.;
NCCN(R) is a registered trademark of National Comprehensive Cancer Network.
File: Antengene Announces its U.S. Partner, Karyopharm Therapeutics Inc.,
has received FDA Approval of XPOVIO(R) (Selinexor) as a Treatment for
Patients with Multiple Myeloma After At Least One Prior Therapy [1]
21/12/2020 Dissemination of a Marketing Press Release, transmitted by EQS
Group.
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(END) Dow Jones Newswires
December 21, 2020 02:22 ET (07:22 GMT)
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