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Antengene Corporation Limited (Antengene), a leading innovative, commercial-stage global biopharmaceutical company, 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).
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 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.
Prof. Jun Zhu, principal investigator of the SEARCH study from Peking University affiliated Beijing Cancer Hospital, said, “DLBCL is the most common subtype of NHL in adults and accounts for 40% of all NHL cases in China. The incidence of NHL has been steadily rising year over year, while patients with third- and later-lines relapsed or refractory disease lack effective and convenient therapies. As a nuclear export protein inhibitor with a novel mechanism of action (MOA), selinexor offers patients a new treatment option that is efficacious and easy to use, with oral availability that can reduce hospitalization and financial burden on patients by allowing them to receive treatment at home. Overall, the approval for this new indication of selinexor is indeed a great news for Chinese patients with R/R DLBCL.”
With a novel mechanism of action, Xpovio is the world’s first 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.
Xpovio is the world’s first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.
By blocking the nuclear export protein XPO1, Xpovio can promote the intranuclear accumulation and activation of tumour suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. Xpovio delivers its antitumor effects through three mechanistic pathways: 1) exerting antitumor effects by inducing the intranuclear accumulation of tumour suppressor proteins; 2) reducing the level of oncogenic proteins in the cytoplasm by inducing the intranuclear accumulation of oncogenic mRNAs; 3) restoring hormone sensitivity by activating the glucocorticoid receptors (GR) pathway. To utilize its unique mechanism of actions, Xpovio is being evaluated for use in multiple combination regimens in a range of indications. At present, Antengene is conducting multiple clinical studies of Xpovio in the mainland of China for the treatment of relapsed/refractory hematologic malignancies and solid tumours (3 of these studies are being jointly conducted by Antengene and Karyopharm Therapeutics Inc.
Antengene Corporation Limited is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumours, in realizing its vision of “Treating Patients Beyond Borders.”
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