SHANGHAI and HONG KONG, June 4, 2021 /PRNewswire/ -- 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 results from the Phase II MARCH trial of selinexor plus low dose dexamethasone (the Sd regimen) for the treatment of Chinese patients with relapsed or refractory multiple myeloma (RRMM) are published at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2021 European Hematology Association (EHA) Virtual Congress.
Data from a planned analysis of the first 60 treated patients with a median follow-up of 9.5 months demonstrates an overall response rate (ORR) of 26.7%. Meanwhile, an ORR of 33.3% was achieved with the Sd regimen in triple-class-exposed (IMiDs, PIs and anti-CD38 mAb) patients, and an ORR of 44.4% was achieved in patients that previously received CAR-T therapies. In Chinese patients that were refractory to both immunomodulatory agents (IMiDs) and proteasome inhibitors (PIs), results from the MARCH trial have confirmed the efficacy and manageable safety profile of the Sd regimen, which is consistent with that observed in the STORM trial, the data from which supported the accelerated approval of selinexor by the U.S. Food and Drug Administration (FDA).
Selinexor, the first-in-class XPO1 inhibitor approved for the treatment of RRMM and relapsed or refractory diffuse large B-cell lymphoma (RRDLBCL), has five regimens added to the National Comprehensive Cancer Network (NCCN®) Guidelines and four regimens added to the Chinese Society of Clinical Oncology (CSCO) Diagnosis and Treatment Guidelines. Antengene has submitted new drug applications (NDAs) for selinexor in five APAC markets and anticipates receiving approvals for these NDAs in Q4 2021 and Q1 2022.
ASCO 2021 Annual Meeting
The full abstract is now available at:
https://meetinglibrary.asco.org/record/195519/abstract
Abstract Title:
Results of the phase 2 MARCH Study: Oral ATG-010 (Selinexor) plus low dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma (RRMM) previously treated with an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI).
Abstract #: e20002
EHA2021 Virtual Congress
The full abstract is now available at:
Abstract Title:
Results of the phase 2 MARCH Study: Oral ATG-010 (Selinexor) plus low dose dexamethasone in Chinese patients with relapsed/refractory multiple myeloma (RRMM) previously treated with an immunomodulatory agent (IMiD) and a proteasome inhibitor (PI).
Abstract #: PB1670
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage R&D driven biopharmaceutical company focused on innovative medicines for oncology and other life-threatening diseases. Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since its establishment in 2017, Antengene has built a broad and expanding pipeline of clinical and pre-clinical stage assets through partnerships as well as in-house drug discovery, and obtained 15 investigational new drug (IND) approvals and submitted 5 new drug applications (NDA) in multiple markets in Asia Pacific. Antengene's vision is to "Treat Patients Beyond Borders". Antengene is focused on and committed to addressing significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.
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*The STORM trial, initiated by Karyopharm, is a multicenter, single-arm, open-label Phase IIb trial designed to evaluate the efficacy of selinexor plus dexamethasone (Xd) in patients with relapsed or refractory multiple myeloma.