Antengene Corporation Limited announced that Xpovio (selinexor) in combination with bortezomib and dexamethasone (XVd) has been approved for reimbursement in Taiwan for adult patients with relapsed/refractory multiple myeloma (R/R MM) who have received at least two prior therapies. The treatment will be officially included in Taiwan's National Health Insurance (NHI) drug reimbursement scheme starting March 1, 2025.
This approval marks a significant milestone for patients in Taiwan struggling with this challenging hematologic malignancy. Xpovio, as the world's first approved orally-available selective inhibitor of the nuclear export protein XPO1, offers a novel mechanism of action that distinguishes it from existing treatment options.
Expanding Access Across Asia-Pacific
Taiwan becomes the fifth market in the Asia-Pacific region to include Xpovio in its public insurance scheme, following mainland China, South Korea, Australia, and Singapore. The drug has received regulatory approval in a total of nine countries and regions across APAC, with Antengene actively working to extend public health insurance coverage throughout the region.
Dr. Jay Mei, Founder, Chairman and CEO of Antengene, commented on the significance of this development: "The inclusion of Xpovio in Taiwan's reimbursement scheme represents our commitment to improving access to innovative cancer therapies. This approval will substantially reduce the financial burden for eligible patients and their families, providing a much-needed treatment option for those who have progressed on previous therapies."
Multiple Myeloma Burden in Taiwan
Multiple myeloma, a malignancy caused by the dysregulated proliferation of plasma cells, represents a significant health challenge in Taiwan. According to epidemiological data, MM is the second most prevalent hematologic malignancy in the region, with approximately 700 to 800 newly diagnosed cases and around 400 related deaths annually.
Patients with multiple myeloma face numerous treatment challenges, including a high propensity for relapse, limited survival periods, and restricted therapeutic options. The reimbursement approval for Xpovio addresses a critical unmet need in the treatment landscape.
Novel Mechanism of Action
Xpovio's effectiveness stems from its unique mechanism of action. By blocking the nuclear export protein XPO1, the drug promotes the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins while simultaneously down-regulating levels of multiple oncogenic proteins.
The drug delivers its antitumor effects through three distinct mechanistic pathways:
- Inducing the intranuclear accumulation of tumor suppressor proteins to exert antitumor effects
- Reducing oncogenic protein levels in the cytoplasm by inducing intranuclear accumulation of oncogenic mRNAs
- Restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway
These mechanisms contribute to Xpovio's synergistic effects in combination regimens, fast onset of action, and durable responses in patients with limited treatment options.
Future Directions
While expanding Xpovio's availability across APAC markets, Antengene is simultaneously working to broaden the drug's clinical applications. Leveraging its novel mechanism of action, the company is developing Xpovio with multiple combination regimens for additional indications, including myelofibrosis (MF) and endometrial cancer.
Currently, Antengene is conducting multiple clinical studies of Xpovio in mainland China for the treatment of relapsed/refractory hematologic malignancies and solid tumors. Three of these studies are being jointly conducted with Karyopharm Therapeutics Inc., the original developer of selinexor.
Clinical Implications
For healthcare providers in Taiwan, the reimbursement approval offers an important addition to the treatment armamentarium for patients with relapsed/refractory multiple myeloma who have exhausted at least two prior lines of therapy.
The XVd combination (Xpovio with bortezomib and dexamethasone) provides a novel approach that may benefit patients who have developed resistance to existing treatment modalities. The oral administration route also offers convenience advantages compared to some alternative therapies that require intravenous administration.
As Antengene continues its mission of "Treating Patients Beyond Borders," the reimbursement approval in Taiwan represents another step toward improving outcomes for cancer patients throughout the Asia-Pacific region.
