Antengene Presents Results from Two Late-Stage Clinical Studies of Selinexor at ASH 2024

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that it presented the latest data from two clinical studies of selinexor in two posters at the 2024 American Society of Hematology Annual Meeting (ASH 2024).

Details on the Posters:

Title: Weekly Selinexor, Bortizomib and Dexamethasone (SVd) Versus Twice Weekly Bortizomib and Dexamethasone (Vd) in Chinese Patients with Relapsed and Refractory Multiple Myeloma (RRMM): Primary Analysis of Phase III Bench Study
Publication Number: 4748
Session: 654. Multiple Myeloma: Pharmacologic Therapies: Poster III
Date: Monday, December 9, 2024
Time: 6:00 PM - 8:00 PM (Pacific time)
          10:00 AM - 12:00 PM, December 10, 2024 (Beijing time)

• The BENCH study is a Phase III randomized, open-label, multicenter clinical trial, aiming to evaluate the efficacy and safety of selinexor, bortezomib and dexamethasone (SVd) regimen against bortezomib and dexamethasone (Vd) regimen in Chinese adult patients with R/R MM who have received one to three prior lines of therapy. At present, a New Drug Application (NDA) based this study has already been submitted to and accepted by China's National Medical Products Administration (NMPA).

• As of May 9, 2024, a total of 154 Chinese R/R MM patients were randomized to SVd group (n=101) or Vd group (n=53) and 152 patients received at least one dose of study drug (safety population).

• Efficacy results showed that the median progression-free survival (mPFS) was 8.1 months with SVd group and 6.3 months with Vd group. The overall response rate (ORR) was higher in SVd group than in Vd group. SVd group had a significantly higher proportion of patients with a very good partial response (VGPR) or better responses. The median time to response and the median duration of response were 0.8 vs 1.4 months and 9.7 vs 7.2 months (SVd vs Vd), respectively.

• During the study, some subjects experienced treatment emergent adverse events (TEAEs). The most frequent Grade 3-4 adverse events (AEs) for SVd and Vd (≥10%) included thrombocytopenia, lymphocytopenia, and anemia. The incidence of Grade≥2 peripheral neuropathy (PN) was significantly lower in SVd than in Vd group.

• The BENCH study has met its primary and key secondary endpoints, with results consistent with the BOSTON study. These results showed that the SVd regimen decreased the risk of progression and obtained much more profound responses compared to standard Vd regimen in Chinese patients with R/R MM. The incidence of Grade ≥2 PN were significantly reduced.

Title: Selinexor Combined with Tislelizumab in Patients with Relapsed or Refractory Extranodal NK/T-Cell Lymphoma (R/R ENKTL): Preliminary Results of Arm C, from a Multicenter, Single-Arm, Phase I/II Study, Touch
Publication Number: 4448
Session: 625. T Cell, NK Cell, or NK/T Cell Lymphomas: Clinical and Epidemiological: Poster III
Date: Monday, December 9, 2024
Time: 6:00 PM - 8:00 PM (Pacific time)
          10:00 AM - 12:00 PM, December 10, 2024 (Beijing time)

• The Phase I/II TOUCH study is investigating selinexor combined with different drugs in R/R ENKTL. Arm C of the study aims to evaluate the safety, tolerability and preliminary efficacy of selinexor in combination with anti-PD-1 antibody tislelizumab.

• As of 18 May 2024, 17 R/R ENKTL patients were enrolled in Arm C [Sel 40mg (n=3); Sel 60mg (n=14)]. Sixteen patients previously exposed to both L-asparaginase (L-Asp) and checkpoint inhibitors (CPIs) including 8 patients who had received prior Tislelizumab (Tis); eleven (64.7%) patients were refractory to their last-line therapy.

• Efficacy results showed that, of 16 CPIs exposed patients (one patient was efficacy non-evaluable), the ORR was 75% (12/16), including 7 CRs and 5 PRs; and the median PFS was 6.7 months (95% CI 1.5, NE).

• During the study, all patients experienced TEAEs. The most common TEAEs included anemia, neutropenia, asthenia, decreased appetite, weight loss, and thrombocytopenia. Ten patients (58.8%) experienced Grade≥3 TEAEs. Treatment emergent serious adverse events (TESAEs) occurred in 4 patients (23.5%), of which two were considered treatment related. No patient discontinued due to TEAEs. Most of toxicities were manageable by dose modification and supportive care.

• In the study, the chemo-free regimen, Sel plus Tis, showed a favorable response rate and manageable safety profile in R/R ENKTL. This approach may probably reverse drug resistance in ENKTL that has progressed after prior CPI treatment.

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) 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 tumors, in realizing its vision of "Treating Patients Beyond Borders".

Since 2017, Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 10 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand and Australia.

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