DJ EQS-News: Antengene Announces Acceptance of IND Application in China for ATG-010 (Selinexor) in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL in a Global Phase 2/3 Study
EQS-News / 07/12/2020 / 14:07 UTC+8
Antengene Announces Acceptance of IND Application in China for ATG-010
(Selinexor) in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL
in a Global Phase 2/3 Study
Shanghai and Hong Kong, PRC, December 7, 2020-- Antengene Corporation
Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical
company dedicated to discovering, developing and commercializing global
first-in-class and/or best-in class therapeutics in hematology and oncology,
announced that the National Medical Products Administration (NMPA) has
accepted the Investigational New Drug (IND) application for ATG-010
(selinexor) combined with R-GDP (SR-GDP) for the treatment of
relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). The trial is a
global Phase 2/ 3, multicenter, randomized study aiming to evaluate the
safety and efficacy of ATG-010 in combination with R-GDP (SR-GDP) in
patients with rrDLBCL (Code: XPORT-DLBCL-030).
ATG-010 is a first-in-class and only-in-class oral selective inhibitor of
nuclear export, developed by Antengene and Karyopharm Therapeutics Inc.
(NASDAQ: KPTI). In July 2019, the US Food and Drug Administration (FDA)
approved ATG-010 in combination with low-dose dexamethasone for the
treatment of relapsed/refractory multiple myeloma (rrMM). After its initial
approval of rrMM, FDA approved ATG-010 as a single-agent for the treatment
of rrDLBCL in June 2020. In China, Antengene is conducting a registrational
Phase 2 clinical trial to evaluate the efficacy and safety of ATG-010 in the
treatment of patients with rrDLBCL who have received at least 2 but no more
than 5 previous systemic regimens and the first patient was dosed in April
2020.
The Phase 2 part of the study aims to identify the optimal dose of ATG-010
(40mg or 60mg) in combination with R-GDP and will also evaluate the SR-GDP
regimen against an active R-GDP comparator arm. The Phase 3 part of the
study contains three arms and aims to evaluate the selected optimal dose of
ATG-010 in combination with R-GDP for up to 6 cycles followed by continuous
ATG-010 (SR-GDP->S) until disease progression versus the selected optimal
dose of ATG-010 in combination with R-GDP for up to 6 cycles followed by
placebo (SR-GDP->P) until disease progression and versus standard R-GDP with
matching placebo for up to 6 cycles followed by placebo (PR-GDP->P) until
disease progression. The study will be conducted at multiple international
centers across 11 countries, including China, U.S., Europe, Australia and
other countries. Up to 501 patients will be enrolled and treated in the
Phase 2/3 study.
"The submission of NDAs for ATG-010 in multiple APAC markets in the past few
weeks has marked a significant milestone for Antengene as our lead product
candidate, ATG-010, advances towards commercial stage. This IND acceptance
of ATG-010 in a new therapy for rrDLBCL marks another important milestone
for Antengene, demonstrating our commitment to bringing innovative oncology
therapies to cancer patients worldwide." Dr. Jay Mei, Founder, Chairman and
CEO of Antengene, commented, "We look forward to harnessing the power of
Antengeners to extend the lives and improve the quality of life of patients
by discovering, developing and commercializing novel therapies."
About ATG-010 (selinexor, XPOVIO(R))
ATG-010 (selinexor, XPOVIO(R)) is a first-in-class and only-in-class oral
selective inhibitor of nuclear export compound, developed by Antengene and
Karyopharm Therapeutics Inc. (NASDAQ: KPTI). In July 2019, the US Food and
Drug Administration (FDA) approved ATG-010 in combination with low-dose
dexamethasone for the treatment of relapsed/refractory multiple myeloma
(rrMM) and in June 2020 approved ATG-010 as a single-agent for the treatment
of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 is
so far the first and only oral SINE compound approved by the FDA. ATG-010 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
Therapeutics, presented positive results from the Phase 3 randomized, double
blind, placebo controlled, cross-over SEAL study evaluating single agent,
oral ATG-010 versus matching placebo in patients with liposarcoma.
Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of
ATG-010 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
ATG-010 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, obtained 10 investigational new drug approvals
and has 9 ongoing cross-regional clinical trials 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.
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that our actual future results or performance may be materially different
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the date of this article. Any of these intentions may alter in light of
future development.
XPORT-DLBCL-030 was initiated by Karyopharm Therapeutics Inc.;
XPOVIO(R) is a registered trademark of Karyopharm Therapeutics Inc.;
R-GDP: Rituximab, Gemcitabine, Dexamethasone and Cisplatin.
File: Antengene Announces Acceptance of IND Application in China for ATG-010
(Selinexor) in Combination with R-GDP (SR-GDP) for the Treatment of rrDLBCL
in a Global Phase 2/3 Study [1]
07/12/2020 Dissemination of a Marketing Press Release, transmitted by EQS
Group.
The issuer is solely responsible for the content of this announcement.
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December 07, 2020 01:07 ET (06:07 GMT)
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