Antengene’s Xpovio (selinexor) has recently been approved by the China National Medical Products Administration (NMPA) as a monotherapy for the third-line treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL). This marks the entry of the second oral drug for this condition in China, intensifying competition in the market, says GlobalData, a leading data and analytics company.

Antengene entered into an exclusive license agreement with Karyopharm Therapeutics Inc. in 2018 for the development and commercialization of four of Karyopharm’s novel, oral drugs: selinexor, eltanexor, verdinexor and KPT-9274. The agreement includes the development and commercialization of selinexor for oncology indications in China and Macau.

The approval for the new indication was supported by data from the registrational SEARCH study in China. The study enrolled 60 Chinese patients with DLBCL. The results showed that patients 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.

Nelluri Geetha, Pharma Analyst at GlobalData, comments: “In China, DLBCL is the most common sub-type of Non-Hodgkin’s lymphoma (NHL). The standard treatment in the management of DLBCL in China is the addition of rituximab to an anthracycline-containing chemotherapy regimen. Hepatitis B virus (HBV) reactivation is a serious complication for patients with DLBCL treated with rituximab-containing chemotherapy.”

The current marketed drug space for R/R DLBCL in China includes drugs that target B lymphocyte antigen CD19 (axicabtagene ciloleucel, relmacabtagene autoleucel, and loncastuximab tesirine-lpyl – second line), B lymphocyte antigen CD20 (glofitamab-gxbm – second line) and histone deacetylase 1, 2, 3 (tucidinostat – first line). Amongst these, only tucidinostat is administered orally. However, tucidinostat in combination with R-CHOP has been approved by NMPA for DLBCL, whereas Xpovio is approved as monotherapy for DCBCL in China. Also, Xpovio is globally the first approved selective XPO1 inhibitor.

Xpovio was approved in China for R/R multiple myeloma in 2021. Xpovio is already approved for R/R multiple myeloma in the US, Canada, France, Germany, Italy, the US, Spain, Israel, and South Korea for R/R multiple myeloma, whereas Xpovio is approved for DLBCL in the US, Israel, and South Korea.

Geetha concludes: “The oral drugs in late-stage development for DLBCL in China are CUDC-908 (pre-registration – third line), acalabrutinib maleate – Phase III (first and second line) and orelabrutinib (Phase III – first line and Phase II -second and third line). Considering the pipeline and marketed oral drugs for DLBCL, competition is expected to intensify within this segment.”