Antengene Announces Acceptance of IND Application in China for a Phase 3 Clinical Trial of ATG-010 (Selinexor) in Combination with Bortezomib and Dexamethasone (SVd) for the Treatment of rrMM

Dec 11, 2020View PDF

Shanghai and Hong Kong, PRC, December 11, 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), an oral Selective Inhibitor of Nuclear Export (SINE) compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China.

The trial is a randomized, controlled, open-label, multicenter, Phase 3 trial, aiming to evaluate the efficacy and safety of ATG-010, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with rrMM who have received one to three prior lines of therapy. A total of 150 patients will be randomized in a 2:1 ratio to receive SVd or Vd treatment.

ATG-010 is a first-in-class and only-in-class oral selective inhibitor of nuclear export and it is now the first and only drug approved by the Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma. In China, Antengene is conducting a registrational Phase 2 clinical trial of ATG-010 for rrMM (MARCH). The trial is expected to complete enrollment by the end of 2020.

“The result of the BOSTON study has demonstrated that the SVd regimen reduced the risk of disease progression or death with lower doses of bortezomib and dexamethasone in the triplet combination when compared to the standard Vd regimen. Addition of ATG-010 to Vd may be more convenient and provides a more significant therapeutic effect in patients with rrMM.” said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. “This planned Phase 3 trial, which is the registrational study based on BOSTON, is going to validate the SVd regimen’s efficacy and safety in Chinese population.”

About ATG-010 (selinexor, XPOVIO®)

ATG-010 (selinexor, XPOVIO®) 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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XPOVIO® is a registered trademark of Karyopharm Therapeutics Inc.
BOSTON study is initiated by Karyopharm Therapeutics Inc., the study aims to evaluate selinexor in combination with bortezomib and dexamethasone (SVd) compared to standard bortezomib plus dexamethasone (Vd) in patients with multiple myeloma who have received one to three prior lines of therapy.