Antengene Corporation Limited announced that the China National Medical Products Administration (NMPA) has approved a new indication of XPOVIO® (selinexor) as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). A Novel Therapy Bringing Long-awaited Clinical Breakthrough to the Treatment of R/R DLBCL: DLBCL is one of the most common subtypes of non-Hodgkin lymphoma (NHL) in adults and is highly heterogeneous malignancy in both clinical manifestations and prognosis. The current standard treatment, immunotherapy, offers patients with DLBCL a five-year progression-free survival rate of 60%-65% and curative outcomes for 40%-50% of treated patients.

However, 10%-15% of DLBCL patients do not respond to standard first-line treatment, and 20%-25% experience relapses after achieving initial responses, leading to a poor prognosis and enormous unmet clinical needs. The Clinically Validated Efficacy and Convenience of Oral Administration of Selinexor Offer Benefits to a Broad Spectrum of Patients. The approval for the new indication was supported by data from the registrational SEARCH study in China.

Results from the study, which enrolled a total of 60 Chinese patients with DLBCL, showed that patients treated in the trial achieved a central radiological review assessed overall response rate (ORR) meeting the pre-specified primary endpoint. The SEARCH study demonstrated clear efficacy of orally-administered selinexor monotherapy in Chinese patients, exhibiting significant response rates, durable responses, long survival. Approved in 40+ Markets Globally with Expanding Insurance Coverage Across APAC: With a novel mechanism of action, XPOVIO® is the approved orally-available, selective XPO1 inhibitor.

XPOVIO® has a global commercial presence with approvals in over 40 countries and regions. To date, XPOVIO® has already been included for health insurance coverage in the mainland of China, Australia, Singapore and South Korea. Antengene has also submitted the NDAs in additional ASEAN markets, including Thailand, Malaysia and Indonesia, where approvals are expected in the H2 of 2024.