Shanghai and Hong Kong, PRC, December 14, 2021 – 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.
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 2021.” Dr. Mei continued, “The TOUCH study is one of 10 studies underway at Antengene with ATG-010 – and very much in keeping with Antengene’s commitment to develop combination therapies for our pipeline programs to treat cancers where there are limited therapeutic options. We look forward to progress the ATG-010 clinical program, with gratitude to our partners, clinical collaborators and patients.”
Details on the poster:
XPO1 Inhibitor (ATG-010) Plus Chemotherapy per Investigator’s Choice for Heavily Pretreated Patients with Relapsed or Refractory (R/R) Peripheral T-Cell Lymphoma (PTCL) and Extranodal NK/T-Cell Lymphoma (ENKTL)：Preliminary Results from a Multicenter, Single-Arm Phase Ib Study (TOUCH Trial) (Abstract# 2452)
Session Name: 624. Hodgkin Lymphomas and T/NK cell Lymphomas: Clinical and Epidemiological: Poster II
Session Date: Sunday, December 12, 2021
Session Time: 6:00 PM – 8:00 PM ET
Venue: Hall B5, Georgia World Congress Center
Details for the ASH 2021 abstracts for ATG-010 and related “SINE” compounds
Seventeen additional abstracts related to selinexor and eltanexor are were presented at ASH by Karyopharm Therapeutics, Inc. (NASDAQ :KPTI), Antengene’s partner (see the link: Karyopharm Press Release on Nov. 4, 2021).
About the SINE Compounds
SINE (Selective Inhibitor of Nuclear Export) compounds are agonists of the major nuclear export protein Exportin 1 (XPO1). Currently, there are three oral SINE compounds, ATG-010 (Selinexor), ATG-016 (Eltanexor), and ATG-527 (Verdinexor), under clinical development for related indications. Antengene has an exclusive license from Karyopharm Therapeutics (Karyopharm) to these compounds in the APAC markets.
About ATG-010/Selinexor/ XPOVIO®
Selinexor is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins, and down-regulate the levels of multiple oncogenic proteins. This induces apoptosis without affecting normal cells. Due to its novel mechanism of action, selinexor can be used in multiple combination regimens to improve treatment efficacy.
Selinexor is approved by the US FDA for the treatment of relapsed/refractory multiple myeloma (RRMM) and relapsed/refractory diffuse large B‑cell lymphoma.
Antengene secured approval of selinexor in South Korea through a priority review process. Antengene is conducting 10 studies with selinexor in mainland China (3 in collaboration with Karyopharm) for relapsed/refractory/advanced solid tumor and hematological cancers.
Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading clinical-stage R&D- driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for oncology and other life-threatening diseases. Driven by its vision of “Treating Patients Beyond Borders”, Antengene aims to provide the most advanced anti-cancer drugs to patients in the Asia Pacific Region and around the world. Since initiating operations in 2017, Antengene has obtained 20 investigational new drug (IND) approvals in the US and in Asia, submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for selinexor/ATG-010 in South Korea already approved through a priority review process. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. The Company has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.
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