Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it presented results of the Company-sponsored, open-label Phase 1b TOUCH study with selinexor (ATG-010) for the treatment of relapsed/refractory (RR) T and NK-Cell lymphoma, in a poster presentation (NCT04425070, see details below) at the 2021 ASH Annual Meeting, being held from December 11-14, 2021, both in Atlanta, Georgia and virtually.
https://www.hematology.org/meetings/annual-meeting
Eligible patients (pts) for TOUCH were RR T and NK-cell lymphoma cases with at least one prior systemic therapy. Primary endpoints were overall response rate (ORR) and safety. Total of 26 Chinese pts were enrolled treated with ATG-010 plus GemOx therapy. Half of the pts belonged to peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and 26.9% pts were extranodal NK/T-cell lymphoma (ENKTL). Fifty percent pts had ≥3 lines of prior treatment, and 57% pts had prior exposure to a gemcitabine-based regimen.
ATG-010 plus GemOx therapy demonstrated favorable treatment activity, especially in pts with PTCL-NOS and ENKTL with numerically better response and PFS. Total ORR reached 46.2%, with CR rate (CRR) of 26.9%, and median PFS of 2.7 months (mos). ORR for PTCL-NOS and ENKTL subgroups reached 53.8% and 57.1%, CR of 30.8% and 28.6%, and median PFS of 4.4 mos and 4.7 mos, respectively.
ATG-010 plus GemOx therapy presented a manageable safety profile. Majority of ≥grade 3 treatment emergent adverse events (TEAEs) were hematological events (thrombocytopenia, neutropenia and anemia). Non-hematological events were low grade and reversible, most of which were gastrointestinal events. After optimal supportive care and dose modification, these adverse events were manageable in general.
Prof. Huiqiang Huang, M.D., from the Lymphoma Center of Sun Yat-Sen University Affiliated Cancer Hospital, commented: "PTCL and NKTCL are both highly heterogeneous and aggressive diseases with markedly higher prevalence in China than in western countries. Existing treatments only offer limited results, especially in relapsed or refractory patients who commonly have a very poor prognosis as the salvage treatment with conventional chemotherapies only produce low and brief responses. Currently, there is high unmet medical need in this patient population, especially older patients and patients who are not eligible for transplants due to concurrent diseases. The TOUCH trial represents a whole new strategy adopting selinexor, a first- and only-in-class, orally-administered, selective inhibitor of nuclear export compound with a novel mechanism of action that can synergize with chemotherapies to offer improved efficacy. Existing clinical data of selinexor in combination with the GemOx regimen already showed encouraging efficacy and safety. Given that the study is being conducted in China, it has particular significance for Chinese patients. We hope selinexor will offer a new treatment option and fresh hope to those patients."
"Antengene is encouraged by the promising clinical efficacy and safety data from the Phase 1b TOUCH study. There is a clear need for new therapeutic options for heavily pre-treated patients with relapsed/refractory T and NK-cell lymphoma," said Kevin Lynch, M.D., Chief Medical Officer of Antengene. "We are enthusiastic to expand these studies and look forward to initiating an appropriately powered expansion study of the combination of ATG-010 and GemOx to further explore safety and efficacy in these patients," continued Dr. Lynch.
Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene commented, "Antengene's first commercial product is ATG-010. We have secured approval in South Korea and anticipate approval in China around year-end ...
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