China-based Antengene Corporation Limited (Antengene, HKG: 6996) announced the presentation of the latest results from two clinical studies for its Xpovio (selinexor) at the 2024 American Society of Hematology Annual Meeting (ASH 2024).
Phase III BENCH Study Results
The Phase III BENCH study evaluated the efficacy and safety of the selinexor, bortezomib, and dexamethasone (SVd) regimen against the bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with relapsed and refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. As of May 9, 2024, a total of 154 Chinese R/R MM patients were randomized to the SVd group (n=101) or Vd group (n=53), with 152 patients receiving at least one dose of the study drug (safety population). The study met its primary and key secondary endpoints, showing a median progression-free survival (mPFS) of 8.1 months in the SVd group versus 6.3 months in the Vd group. The overall response rate (ORR) was higher in the SVd group, and the incidence of Grade≥2 peripheral neuropathy (PN) was significantly lower in the SVd group compared to the Vd group.
Phase I/II TOUCH Study Results
The Phase I/II TOUCH study investigated selinexor combined with different drugs in relapsed or refractory extranodal NK/T-Cell Lymphoma (R/R ENKTL). Arm C of the study assessed the safety, tolerability, and preliminary efficacy of selinexor in combination with the anti-PD-1 antibody tislelizumab. As of May 18, 2024, 17 R/R ENKTL patients were enrolled in Arm C. Efficacy results showed an ORR of 75% (12/16) among 16 CPIs exposed patients, including 7 complete responses (CRs) and 5 partial responses (PRs), and a median PFS of 6.7 months. No patient discontinued due to treatment-emergent adverse events (TEAEs), and most toxicities were manageable through dose modification and supportive care.
Xpovio’s Global Reach and Development
Discovered by US-based Karyopharm Therapeutics Inc., (NASDAQ: KPTI), Xpovio is the world’s first and only FDA-approved oral XPO1 inhibitor used to treat hematological malignancies. Karyopharm licensed the rights for the drug to Antengene in Greater China, South Korea, and ASEAN countries in May 2018. Xpovio has been approved in mainland China, Hong Kong, Macao and Taiwan, South Korea, Singapore, Malaysia, Australia, etc., for use in multiple myeloma and is also being tested in myelofibrosis (MF), T-cell non-Hodgkin lymphoma (T-NHL), and other indications.-Fineline Info & Tech
