On May 18, 2022 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, reported that the uses of XPOVIO(selinexor) for Multiple Myeloma (MM) patients with first relapse or multiple relapses were incorporated into the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) (Press release, Antengene, MAY 18, 2022, View Source [SID1234614836]). This is the first time that selinexor has been included in the guidelines.
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The Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) was jointly developed and revised by the Chinese Hematology Association of the Chinese Medical Doctor Association (CMDA) and the Chinese Society of Hematology of the Chinese Medical Association (CMA), and was published in the Chinese Journal of Internal Medicine in May 2022.
The 2022 Guidelines for MM incorporated four selinexor combination therapy regimens comprised of selinexor and other biological and/or chemotherapy agents. Recommendations for the treatment of relapsed/refractory MM (R/R MM) are based on the multiple sources of medical evidence including patients’ response to prior treatment. As one of the most recognized guidelines in China, the guidelines are widely adopted among Chinese oncologists in their clinical practice.
Prof. Jin Lu, at Peking University People’s Hospital, commented, "MM is a malignancy that arises from plasma cells in the bone marrow, commonly occurring in middle-aged and elderly populations. As a result of an aging population, the incidence of MM has been rising sharply in China in recent years. Despite the medical advances in MM in the past two decades, R/R MM still remains a major clinical challenge faced by clinicians in day-to-day practices. Selinexor, the world’s first oral inhibitor of the nuclear export protein, was jointly recommended by the CMDA and CMA in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision), which indicates strong recognition of selinexor’s therapeutic utility in Myeloma. Meanwhile, we hope that other on-going studies will generate additional data supporting even wider clinical adoption of selinexor."
Dr. Jay Mei, Antengene’s Founder, Chairman and CEO said, "Antengene is pleased to fulfill our mission of treating cancer patients with relapsed/refractory disease by bringing selinexor to the market in China and other Asia Pacific geographies. Inclusion in the Guidelines for the Diagnosis and Management of Multiple Myeloma in China (2022 revision) is important because it highlights the robust clinical evidence that supports the use of selinexor in patients with R/R MM from first relapse through the full spectrum of disease progression. We believe that the combination of strong clinical data and inclusion into the guidelines for MM will make it easier for practitioners to incorporate selinexor into patient care and pave the way for patients with R/R MM to benefit from this novel therapy."
Dr. Kevin Lynch, Antengene’s Chief Medical Officer added, "Antengene is especially pleased for the use of selinexor to be recommended from the first relapse or multiple relapses. We understand that cancer care is complex and that having effective treatment options for the first relapse that offers the potential for durable disease control is especially important to patients and their families. We look forward to bringing this important therapy to patients in China and other Asia Pacific geographies."
Practice Guidelines for the treatment of relapsed myeloma
The patient’s response to prior treatment
Recommended Regimens
Lenalidomide-sensitive
XDd, XPd, XKd
Lenalidomide-resistant
XDd, XVd, XPd, XKd
Bortezomib-sensitive
XVd, XPd, XKd
Bortezomib-resistant
XDd, XPd, XKd
Resistant to both lenalidomide and bortezomib
XDd, XPd, XKd
*XDd, selinexor plus daratumumab plus dexamethasone; XPd, selinexor plus pomalidomide plus
dexamethasone; XKd, selinexor plus carfilzomib plus dexamethasone; XVd; selinexor plus
bortezomib plus dexamethasone
About Multiple Myeloma (MM)
MM is caused by the dysregulated proliferation of plasma cells. It is the second most common hematologic malignancy in many countries. Despite availability of a number of treatments for relapsed patients, MM is prone to relapse and most patients still succumb to their disease. MM is the second most common hematological malignancy in China, with an estimated about 15,000 to 20,000 new MM patients and 10,300 deaths per year.[1]
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.