China Approves Antengene's XPOVIO for DLBCL

Antengene’s XPOVIO (selinexor) has received approval from China’s National Medical Products Administration (NMPA) for a new indication to treat adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This approval is backed by data from the registrational SEARCH study carried out in China. The trial enrolled 60 Chinese patients diagnosed with DLBCL and successfully met its primary endpoint, demonstrating a centrally assessed overall response rate. The efficacy of selinexor as a monotherapy was highlighted by significant response rates and durable responses among the participants.

XPOVIO holds a unique distinction as the first orally-available selective inhibitor of the nuclear export protein XPO1. This mechanism of action enables the intranuclear accumulation and activation of tumor suppressor proteins, thereby potentially down-regulating several oncogenic proteins. Known for its rapid onset of action, synergistic effects in combination treatments, and sustained responses, XPOVIO has garnered approvals in over 40 countries and regions worldwide.

Antengene is further expanding the reach of XPOVIO by submitting new drug applications in several ASEAN markets, including Malaysia, Thailand, and Indonesia, with approval prospects anticipated in the latter half of 2024.

Diffuse large B-cell lymphoma (DLBCL) is a common subtype of adult non-Hodgkin lymphoma (NHL), characterized by a highly variable prognosis and a broad spectrum of clinical symptoms. Patients undergoing immunotherapy for DLBCL have a five-year progression-free survival rate ranging from 60% to 65%, and 40% to 50% of these patients could potentially be cured. However, a significant proportion, ranging from 20% to 25%, relapse after initial responses, while 10% to 15% show no response to standard first-line therapies.

In addition to its recent approval, Antengene is actively engaged in multiple clinical studies focused on XPOVIO, targeting both hematologic malignancies and solid tumors within mainland China. Three of these studies are collaborative efforts between Antengene and Karyopharm Therapeutics.

Moreover, in August 2023, Antengene entered into a collaboration agreement with Hansoh Pharmaceutical to commercialize XPOVIO in Mainland China. This partnership aims to leverage Hansoh’s extensive market presence and expertise to enhance the availability and reach of XPOVIO among Chinese patients suffering from R/R DLBCL and potentially other malignancies.

These developments underscore Antengene’s commitment to advancing cancer therapies and providing new treatment options for patients with challenging and refractory forms of lymphoma. With ongoing research and strategic partnerships, Antengene is poised to make significant contributions to the field of oncology, particularly in the management of DLBCL.