XPOVIO® (selinexor) Approved for DLBCL in China, Offering New Treatment Option

Following its initial approval for treating relapsed/refractory multiple myeloma (R/R MM), XPOVIO® has now received approval as a monotherapy for adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), marking its second approved indication in China. Results from the registrational SEARCH study in China showed that the overall response rate (ORR) among the 60 Chinese patients treated with XPOVIO® met the study's prespecified primary endpoint.

XPOVIO® is an oral drug with a novel mechanism of action. Antengene is currently developing multiple combination regimens of XPOVIO® for the treatment of various indications including myelofibrosis (MF), T-cell non-Hodgkin's lymphoma (T-NHL), and endometrial cancer. XPOVIO® has been approved for health insurance coverage in the mainland of China, Australia, Singapore, and South Korea. Furthermore, Antengene has submitted new drug applications (NDAs) for XPOVIO® in other ASEAN markets including Thailand, Malaysia, and Indonesia. Approvals in these markets are anticipated in the second half of 2024.

Antengene Corporation Limited, a prominent biopharmaceutical company, announced that the China National Medical Products Administration (NMPA) has approved a new indication of XPOVIO® (selinexor) as a monotherapy for treating adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).

DLBCL is a prevalent subtype of non-Hodgkin lymphoma (NHL) in adults, characterized by a highly heterogeneous malignancy in clinical manifestations and prognosis. Standard treatment through immunotherapy offers a five-year progression-free survival rate of 60%-65% and curative outcomes for 40%-50% of patients. However, a significant portion, 10%-15%, do not respond to first-line treatment, and 20%-25% relapse after initial responses, leading to poor prognosis and substantial unmet clinical needs.

The approval for the new indication was supported by data from the SEARCH study in China, which enrolled 60 Chinese patients with DLBCL. The study showed that patients treated with selinexor achieved a central radiological review-assessed overall response rate (ORR) meeting the pre-specified primary endpoint. The SEARCH study demonstrated the efficacy of orally-administered selinexor monotherapy in Chinese patients, showcasing significant response rates, durable responses, and long survival.

Professor Jun Zhu, principal investigator of the SEARCH study from Beijing Cancer Hospital, emphasized that DLBCL accounts for 40% of all NHL cases in China, with its incidence rising annually. For patients with third- and later-lines relapsed or refractory disease, effective and convenient therapies are scarce. Selinexor, a nuclear export protein inhibitor with a novel mechanism of action, provides a new treatment option that is both efficacious and easy to use. Its oral availability can reduce hospitalization and financial burden on patients by allowing home treatment. The approval of this new indication of selinexor represents a significant advancement for Chinese patients with R/R DLBCL.

XPOVIO® has a global commercial presence with approvals in over 40 countries and regions. It is the world's first approved orally-available, selective XPO1 inhibitor. XPOVIO® has been included for health insurance coverage in China, Australia, Singapore, and South Korea. Antengene has submitted NDAs in additional ASEAN markets, including Thailand, Malaysia, and Indonesia, where approvals are expected in the latter half of 2024.

XPOVIO® promotes the intranuclear accumulation and activation of tumor suppressor proteins and growth-regulating proteins by blocking the nuclear export protein XPO1. It is being evaluated for use in multiple combination regimens for various indications. Currently, Antengene is conducting several clinical studies of XPOVIO® in China for relapsed/refractory hematologic malignancies and solid tumors.