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    Home > Active Ingredient News > Drugs Articles > Selinexor (ATG-010) Phase III Clinical Research SEAL data were published and reported orally at the 2020 Annual Meeting of the Society of Connective Tissue Oncology (CTOS).

    Selinexor (ATG-010) Phase III Clinical Research SEAL data were published and reported orally at the 2020 Annual Meeting of the Society of Connective Tissue Oncology (CTOS).

    • Last Update: 2020-12-20
    • Source: Internet
    • Author: User
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    Selinexor significantly improves the progression-free survival of patients with advanced non-removable decissive liposarcoma who have received at least 2 treatment options in the past (risk ratio: 0.70, p=0.023) According to SEAL Phase III clinical data, Selinexor has Great Potential for Development, Shanghai, China, and Massachusetts, USA, 2 December 2020 - Deki Pharmaceutical Co., Ltd. ("Deki Pharmaceuticals", Hong Kong Stock Exchange Code: 6996. HK) recently announced that its strategic partner Karyopharm Therapeutics Inc. (Karyopharm, NASDAQ®: KPTI) will publish Phase II clinical trial data for the treatment of advanced fatty sarcoma (SEAL) at the 2020 Annual Meeting of Connective Tissue Tumors (CTOS 2020). the
    SEAL study, a randomized, double-blind, placebo-controlled cross-study designed to assess the efficacy and safety of Selinexor single-drug therapy and placebo-controlled patients with late-stage non-surgically removable neurotic liposarcoma, reached the end of the main study and significantly prolonged the patient's progression-free survival (PFS).
    the study data will be used to support Karyopharm's application to the U.S. Food and Drug Administration (FDA) for a new drug in the first quarter of 2021.
    and Karyopharm launched a strategic partnership in 2018 to obtain exclusive development and commercial interests in ATG-010 (Selinexor), ATG-016 (Eltanexor), ATG-527 (Verdinexor) and ATG-019 (KPT-9274) in 17 countries and territories in Asia Pacific.
    Currently, Deqi Pharmaceuticals is conducting a number of clinical studies in China on ATG-010 (Selinexor), including registered clinical trials for the treatment of recurring multiple myeloma and diffuse large B-cell lymphoma, as well as clinical trials of non-small cell lung cancer, outer T-cell lymphoma and NK/T cell lymphoma based on high-risk tumor species in the Asia-Pacific region.
    addition, Deqi Pharmaceuticals is in the Asia-Pacific region for THEG-010 new drug market applications.
    SEAL study of phase II/III SEAL studies showed that the progression-free survival of the Selinexor group was 2.83 months and that the placebo group had a risk ratio of 2.07 months (risk ratio of 0.70; p=0.023).
    data show that Selinexor reduces a patient's risk of disease progression or death by about 30 percent compared to a placebo.
    six-month progression-free survival rates were 23.9 percent and 13.9 percent, respectively, in the Selinexor and placebo groups.
    12-month progress-free survival rate was 8.4 per cent and 2 per cent, respectively, for the two groups.
    in reducing the disease load on patients (in terms of shrinking tumor-targeted lesions), 7.5 percent of patients in the Selinexor group decreased by more than 15 percent, while patients in the placebo group did not observe the change.
    SEAL trial design allows placebo group patients to cross into the Selinexor group after objective disease progression.
    treatment-related adverse events in the SEAL study included blood cell reduction, gastrointestinal and systemic symptoms, consistent with previous Selinexor studies.
    most adverse events can be controlled through dose adjustment and symptom support therapy.
    most common treatment-related non-hematological system adverse events include nausea (81%), decreased appetite (60%), fatigue (51%) and vomiting (49%), and are mainly level 1 and 2 adverse events.
    3 and 4 adverse events associated with the most common treatment include anemia (19%), hyponatreemia (11%), thyroid reduction (10%) and fatigue (10%).
    Since 2012, Selinexor has conducted clinical trials on a wide range of tumors worldwide and has been FDA-approved for the treatment of recurring refractic multiple myeloma and recurring refractic diffuse large B-cell lymphoma, and is currently the only FDA-approved nucleoprotein1 (XPO1) inhibitors, and their application for complementary new drugs (sNDA) for patients with multiple myeloma with 2 lines and above has been submitted to the FDA to expand the new adaptation of Selinexor, which is dated March 19, 2021.
    The SEAL study SEAL (Selinexor treatment of advanced liposarcoma) was a randomized, double-blind, placebo-controlled, multi-center, II/III study (NCT02606461) designed to evaluate the efficacy and safety of Celinexor in patients with non-removable advanced dedifferentiated fatty sarcoma who had received at least 2 lines of treatment twice a week, at a fixed dose of 60 mg.
    57 patients were grouped in the Phase II study (grouped at 1:1) and about 285 patients in the Phase III study group (randomly grouped by 2:1).
    the placebo group were allowed to cross into the Selinexor group after confirming the progression of the disease.
    end point of this study is PFS.
    About Celinexor (XPOVIO®, ATG-010) Selinexor (ATG-010) is a global pioneering, oral, selective nuclear output protein inhibitor that works by binding and suppressing the nuclear output protein XPO1 (also known as CRM1).
    ATG-010 combination of low-dose dexemisun therapy for recurring refracilable multiple myeloma was approved by the FDA in July 2019 and a European Listing License Application (MAA) has been submitted to the European Medicines Agency (EMA).
    June 2020, ATG-010's treatment for recurring, incurable large B-cell lymphoma (including the transformation from folytic lymphoma) that has been treated with at least 2 lines in the past was also accelerated by the FDA.
    At the same time, a new drug application (sNDA) based on the ATG-010 combined boronitazome and low-dose dexamison joint drug in THE BOSTON trial was positive Phase III clinical data for the treatment of patients with recurring recurring refractic multiple myeloma treatments who had received at least one anti-multiple myeloma treatment program (sNDA) and was submitted to the FDA on March 19, 2021.
    In addition, clinical studies of ATG-010 for a number of other blood and solid tumors are under way, including atG-010 as the primary therapeutic drug, in conjunction with other marketed multiple myeloma drugs (code-named STOMP), clinical studies for the treatment of liposarcoma (codenate SEAL) and clinical studies for the treatment of endometrial cancer (code-named SIENDO).
    Deqi Pharmaceuticals is conducting a registered clinical study (code-named MARCH) of ATG-010 in China for recurring resusctic multiple myeloma, a registered clinical study of recurring recurring resuscable treatment of diffuse large B-cell lymphoma (code-named SEARCH), and has initiated clinical studies (codenate TRUMP), exosymetic T-cell lymphoma and NK/T-cell lymphoma (code-named TOUCH).
    about Deki Pharmaceuticals Deqi Pharmaceuticals Limited ("Deki Pharmaceuticals", Hong Kong Stock Exchange Stock Code: 6996. HK) is an Asia Pacific clinical phase biopharmaceutical company focused on innovative anti-tumor drugs, designed to provide cutting-edge, innovative anti-tumor therapies to patients in China, Asia Pacific and around the world.
    Since its inception, Deqi Pharmaceuticals has established a rich product pipeline of 12 clinical and preclinical innovative drugs, obtained 10 clinical approvals, and conducted 9 cross-regional clinical trials in the Asia Pacific region.
    Deqi people to "doctors without borders, innovation and sustainability" as the vision, and strive to solve the world's first and similar optimal therapy research and marketization, to solve the Asia-Pacific and even the world's patients unseeded clinical needs.
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