Specifically, the new drug applications will cover myeloma patients who have received at least four therapies, and failed to respond to at least two immunomodulatory therapies, two proteasome inhibitors, and one CD38 inhibitor.
Applications submitted in Singapore and Australia are requesting the addition of two other indications: for myeloma patients who received at least one line of therapy, in combination with Velcade (bortezomib) and dexamethasone; and for the treatment of diffuse large B-cell lymphoma (DLBCL) patients who received two or more lines of therapy.
The Australian Therapeutic Goods Administration accepted Antengene’s application for review on Dec. 2.
Xpovio, developed by Karyopharm Therapeutics, is a first-in-class oral inhibitor of the XPO1 protein that works by preventing the exit of tumor suppressor proteins from the cell nucleus. This leads to the death of cancer cells while leaving healthy cells unharmed.
The treatment has been approved in the U.S. for relapsed or refractory myeloma patients who have received at least four prior therapies and failed to respond to treatment, and for people with relapsed or refractory DLBCL, including DLBCL arising from follicular lymphoma.
A combination of Xpovio plus Velcade and dexamethasone is also being reviewed in the U.S. for those with multiple myeloma who have had at least one line of therapy, and the European Medicines Agency is considering an accelerated approval of Xpovio as a fifth-line or later myeloma treatment.
Under a collaboration with Karyopharm, Antengene owns the rights to develop and commercialize Xpovio across multiple regions, including mainland China, Macau, Hong Kong, Australia, New Zealand, South Korea, Taiwan, and other Asian countries.
In addition to the recently submitted applications in Singapore, Australia, and Hong Kong, Antengene has received two orphan drug designations for Xpovio in South Korea, one for heavily treated myeloma and the other for DLBCL.
Two ongoing Phase 2 clinical trials in China may also support applications requesting Xpovio’s approval for triple-refractory myeloma patients and for relapsed or refractory DLBCL patients.
The MARCH trial (NCT03944057) is recruiting about 82 myeloma patients who received prior Velcade and Revlimid (lenalidomide) and failed to respond to immunomodulatory agents and proteasome inhibitors.
The SEARCH trial (NCT03992339) is enrolling about 60 patients with DLBCL who received between two and five prior lines of therapy, and are not eligible for high-dose chemotherapy plus stem cell transplant.
Antengene has also launched clinical trials examining Xpovio as a treatment for cancers that are highly prevalent in Asian Pacific regions, including peripheral T-cell lymphoma, NK/T-cell lymphoma, and KRAS-mutant non-small cell lung cancer.
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