Antengene’s XPOVIO® Approved for Second-Line Treatment of Multiple Myeloma
Tuesday, July 29, 2025
Antengene Corporation has announced that the China National Medical Products Administration (NMPA) has approved XPOVIO® (selinexor) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
XPOVIO®, an oral selective XPO1 inhibitor, is the first of its kind approved globally. It has already received approval in ten countries and regions across the Asia-Pacific, and is included in national insurance schemes in five of them, including mainland China, Taiwan, Australia, Singapore, and South Korea.
This marks the third approved indication for the drug in China.
The approval is based on results from the Phase III BENCH study, a randomised, controlled, open-label, multicentre trial involving 154 Chinese patients with relapsed or refractory MM (R/R MM). Patients had previously received one to three lines of treatment. The study compared the combination of selinexor, bortezomib, and dexamethasone (XVd regimen) against the standard Vd regimen.
Findings from the BENCH study showed the XVd regimen offered better clinical outcomes, including longer progression-free survival (PFS), higher overall response rate (ORR), deeper responses, and increased rates of minimal residual disease (MRD) negativity. The results also indicated clinical benefits for elderly patients, especially those aged 65 years and above.
These outcomes were in line with those from the global Phase III BOSTON study, meeting the bridging study’s objectives and supporting the drug’s use in the Chinese population.
Antengene continues to expand the use of XPOVIO® across the region and is currently exploring its potential in other indications such as myelofibrosis and endometrial cancer through various combination therapies.
Source: antengene.com
