On December 18, 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, reported that the National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for ATG-010 (selinexor), an oral Selective Inhibitor of Nuclear Export compound, in combination with bortezomib and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma (rrMM) in China (Press release, Antengene, DEC 18, 2020, View Source [SID1234573103]).
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The trial is a Phase 3 randomized, controlled, open-label, multicenter clinical 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 (SINE) and the first and only drug approved by the Food and Drug Administration (FDA) for use in both relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. In December 2020, National Comprehensive Cancer Network (NCCN) added three different ATG-010 combination regimens to its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for previously treated multiple myeloma, including SVd, SDd and SPd. In China, Antengene is conducting a Phase 2 registrational clinical trial of ATG-010 for rrMM (MARCH).
"The NMPA approval of BENCH trial demonstrates our ability to efficiently execute, and marks a great start of Antegene’s first Phase 3 registrational trial to validate SVd regimen’s efficacy and safety (as evidenced in the global BOSTON trial) in Chinese population." said Dr. Jay Mei, Founder, Chairman and CEO of Antengene. "Since becoming a public company, our clear focus has been on advancing the clinical development of ATG-010. We will initiate immediately our Phase 3 trial of ATG-010 for rrMM patients in China and believe the unique and novel MoA of ATG-010 will provide physicians new treatment options for more oncology indications."
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 Phase 2 registrational 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).