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SHANGHAI and HONG KONG, May 13, 2022 /PRNewswire/ -- Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, announces that the Chinese Society of Clinical Oncology (CSCO), the most prominent medical society for oncology in China, has added multiple XPOVIO® (selinexor) regimens for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) to its 2022 Guidelines for the Diagnosis and Treatment of Hematologic Malignancies and 2022 Guidelines for the Diagnosis and Treatment of Lymphomas (CSCO Guidelines).
The 2022 CSCO Guidelines incorporate a total of four selinexor combination therapy regimens for relapsed myeloma. In addition, the guidelines also recommend the use of selinexor for the treatment of patients with ≥ twice relapsed/progressed DLBCL. As the gold standard guiding Chinese oncologists in their clinical practice, the CSCO Guidelines are one of the most recognized and widely adopted set of practice guidelines in China.
Multiple Myeloma
Guideline for the treatment of relapsed myeloma |
Evidence |
Recommendation |
selinexor plus bortezomib plus dexamethasone* |
Class 1 |
Level I |
selinexor plus pomalidomide plus dexamethasone |
Class 2 |
Level II |
selinexor plus daratumumab plus dexamethasone* |
Class 2 |
Level II |
selinexor plus carfilzomib plus dexamethasone* |
Class 2 |
Level II |
*newly included regimen |
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Incorporation of selinexor into the CSCO guidelines for R/R MM referenced data from the STORM and STOMP trials.
Prof. Wenming Chen, at Beijing Chao-Yang Hospital of Capital Medical University, said, "The continued development of novel therapies is key to improving treatment outcomes for patients with MM. Selinexor, the world's first oral selective XPO1 inhibitor, was granted an approval in China last year, and multiple selinexor regimens have been incorporated into practice guidelines by a number of leading medical societies/organizations. The recent recommendations of selinexor by the updated CSCO Guidelines for the Diagnosis and Treatment of Hematologic Malignancies indicates strong recognition of selinexor's safety and efficacy and is another validation of the robust clinical data supporting the wide clinical adoption of selinexor as a much-needed new treatment option. I hope more patients will soon benefit from this novel therapeutic."
Lymphoma
Guideline for the treatment of ≥ twice relapsed/progressed diffuse large B-cell lymphoma |
Evidence |
Recommendation |
Selinexor monotherapy for third-line and subsequent therapy |
Class 2A |
Level II |
Incorporation of selinexor into the CSCO guidelines for R/R DLBCL referenced data from the SADAL trial, the U.S. Food and Drug Administration's (FDA) approval and the National Cancer Care Network's (NCCN) guideline recommendations for selinexor in patients with R/R DLBCL.
Prof. Weili Zhao, at Ruijin Hospital of Shanghai Jiaotong University School of Medicine, commented, "Primary and secondary drug resistance and intolerance to standard of care therapies in a large portion of DLBCL patients pose a major clinical challenge, limiting the treatment outcomes and survival benefit for patients and resulting in the urgent need for a novel therapy with a new mechanism of action. Selinexor, a small molecule targeted therapy utilizing an innovative mechanism, is approved in the U.S. for the treatment of MM and DLBCL and has received regulatory approvals in various indications in a growing number of countries around the world. This inclusion of selinexor in the CSCO 2022 Guidelines for the Diagnosis and Treatment of Lymphomas presents a new treatment strategy for patients with ≥ twice relapsed/progressed DLBCL, and an important tool for clinicians seeking to change the current standard practices in DLBCL."
About XPOVIO® (selinexor)
Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.
Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene has also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM in March 2022. Antengene is conducting 10 clinical studies in mainland China (3 are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.
About Antengene
Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer and other life-threatening diseases. Driven by its vision of "Treating Patients Beyond Borders", Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 23 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010/XPOVIO® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.
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