Xpovio gains second indication in China

Antengene has announced that Chinese regulators have given the green light for the oral XPO1 inhibitor Xpovio (selinexor) to be used as a monotherapy for adult patients dealing with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This approval is the second for Xpovio in China, following its initial sanction for relapsed/refractory multiple myeloma in 2021.

The recent approval stems from data derived from the SEARCH trial, a registrational study conducted in China. This study involved 60 Chinese patients suffering from DLBCL and achieved its primary goal of overall response rate (ORR). According to Antengene, which is collaborating with Karyopharm Therapeutics on the drug, Xpovio showed "significant response rates, durable responses, and long survival" throughout the trial.

Jun Zhu, the principal investigator of the SEARCH study, highlighted the significance of this approval. "DLBCL is the most common subtype of non-Hodgkin lymphoma (NHL) in adults, accounting for 40% of all NHL cases in China," he stated. Zhu emphasized that Xpovio, with its novel mechanism of action as a nuclear export protein inhibitor, provides a new treatment option that is both effective and user-friendly. Its oral availability means that patients can receive treatment at home, which can reduce hospital visits and healthcare costs.

Xpovio is already approved in over 40 countries and regions around the world, including the United States, where it is indicated for relapsed/refractory DLBCL and second-line multiple myeloma. In the Asia-Pacific region, it has been included in health insurance coverage programs in China, Australia, Singapore, and South Korea.

Antengene has also filed new drug applications for Xpovio in other ASEAN markets, such as Thailand, Malaysia, and Indonesia, and expects approvals in the latter half of 2024. Furthermore, the company is conducting multiple clinical trials of Xpovio in China, exploring combination regimens for treating relapsed/refractory hematologic malignancies and solid tumors. Three of these clinical studies are being conducted in partnership with Karyopharm.