China's National Medical Products Administration (NMPA) has granted approval for Antengene’s new indication of XPOVIO (selinexor) as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL).
The new indication approval for XPOVIO was supported by results from the registrational SEARCH study conducted in China.
The study enrolled a total of 60 Chinese patients with DLBCL.
XPOVIO met the trial's pre-specified primary endpoint, with patients achieving a centrally assessed overall response rate.
The study also demonstrated the efficacy of the orally-administered selinexor monotherapy, showing significant response rates and durable responses.
XPOVIO is the first orally-available, selective inhibitor of the nuclear export protein XPO1.
Its unique mechanism of action allows for the intranuclear accumulation and activation of tumour suppressor proteins, potentially down-regulating multiple oncogenic proteins.
The asset is known for its synergistic effects in combination regimens, rapid onset of action and sustained responses.
XPOVIO has received approvals in more than 40 countries and regions.
Antengene submitted new drug applications (NDAs) in additional ASEAN [Assocation of South East Asian Nations] markets, such as Malaysia, Thailand and Indonesia, with approvals anticipated in the second half of 2024.
DLBCL is one of the most prevalent subtypes of adult non-Hodgkin lymphoma (NHL). It exhibits a very variable prognosis and a range of clinical symptoms.
Patients with DLBCL could have a five-year progression-free survival rate of between 60% and 65% with immunotherapy. 40% to 50% of treated patients will achieve a cure.
But between 20% and 25% of DLBCL patients relapse after obtaining early responses, and 10% to 15% of patients do not respond to typical first-line therapy.
Antengene is conducting several clinical studies of XPOVIO in mainland China for haematologic malignancies and solid tumours.
Three are joint efforts between Antengene and Karyopharm Therapeutics.
In August 2023, Antengene signed a collaboration agreement with Hansoh Pharmaceutical to commercialise XPOVIO in Mainland China.
