Antengene Corporation Limited announced that the Pharmaceutical Administration Bureau of Macau has approved a New Drug Application or XPOVIO® (selinexor), applicable in combination with dexamethasone (Xd), for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents, an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. XPOVIO® is the world's first oral selective inhibitor of the nuclear export protein XPO1, with regulatory approvals in 42 countries and regions including Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore and Australia. The approved indications for each market can be reviewed below.

In addition, multiple XPOVIO® regimens have been added to the clinical practice guidelines of major cancer societies in the U.S., the EU, and APAC, including the National Cancer Care Network Guidelines, the Chinese Society of Clinical Oncology (CSCO) Guidelines, the Guidelines for the Diagnosis and Management of Multiple Myeloma in China, the European Society of Medical Oncology Guidelines, and the International Myeloma Working Group Guidelines. Multiple myeloma (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 hematologic malignancy in China, with an estimated 15,000 to 20,000 new MM patients and 10,300 deaths per year. XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1.

It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses. By blocking the nuclear export protein XPO1, XPOVIO® can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. XPOVIO® delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumor suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway.

To utilize its unique mechanism of actions, XPOVIO® is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting 8 clinical studies of XPOVIO® in mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumors (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc. XPOVIO® is approved in South Korea for the following two indications: In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) 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. As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy.

XPOVIO® is approved in mainland of China for the following indication: In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received prior therapies and whose disease is refractory to at least one proteasome inhibitor, at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody. XPOVIO® is approved in Taiwan China for the following three indications: In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), at least two immunomodulatory agents (IMiDs), and an anti-CD38 monoclonal antibody. In combination with bortezomib and dexamethasone for the treatment of adult patients with MM who have received at least one prior therapy.

As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. XPOVIO® is approved in Hong Kong China, for the following indication: In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents, an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy. XPOVIO® is approved in Macau China, for the following indication: In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors (PIs), two immunomodulatory agents (IMiDs), an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.

XPOVIO® is approved in Australia for the following two indications: In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy. In combination with dexamethasone (Xd) for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.