On August 1, 2021 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 through a priority review process, the South Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s New Drug Application (NDA) for the Orphan Drug-designated first-in-class oral inhibitor of XPO1, selinexor (XPOVIO), in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (rrMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody (penta-refractory); and as a monotherapy for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL) who have received at least two prior lines of treatment (Press release, Antengene, AUG 1, 2021, View Source [SID1234585496]).
Introduction of a practice-changing therapy for MM and DLBCL patients
Most patients with MM eventually suffer from relapse or become refractory diseases. For patients who have failed in one therapy, diffuse large B-cell lymphoma (DLBCL) has poor prognosis and the chance of cure or long-term disease-free survival declined every time getting worse after treatment. At present, there is no cure for rrMM and rrDLBCL and it is in dire need for safer and more effective therapies.
In October 2020, selinexor was granted an Orphan Drug Designation (ODD) in South Korea, where the term "Orphan Drug" is defined by the MFDS as therapies used to treat diseases affecting 20,000 or fewer patients and therapies used to treat diseases for which no appropriate therapy has been developed, or therapies that have demonstrated significant improvement in safety and/or efficacy compared to existing treatments.
A new mechanism of action with a broad therapeutic window
Selinexor’s novel mechanism of action (MoA) which is based on the selective inhibition of the nuclear export protein XPO1, is different from that of all currently approved therapies. The drug can be combined with various therapies to deliver improved treatment outcomes in these diseases. To date, five selinexor-based regimens have been added to the National Comprehensive Cancer Network (NCCN) Guidelines.
In addition, a number of international multicenter clinical trials in respect of selinexor are jointly carried out in places such as North America, Europe, Australia, Asia. These include the study of XPORT-DLBCL-030 in international multicenter clinical trials in combination with R-GDP for the treatment of rrDLBCL, and the study of SIENDO in international multicenter clinical trials of monotherapy of endometrial neoplasms.
Minyoung Kim, General Manager of Antengene, commented: "We are very encouraged by the MFDS’ approval of selinexor. I am confident that this oral selective inhibitor of nuclear export protein, with its practice-changing therapeutic utility, will improve the quality of life of patients with rrMM and rrDLBCL in South Korea, and bring renewed hope to this patient population."
About XPOVIO (selinexor)
XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion.