Preliminary Results from Two Clinical Studies of Selinexor to be Presented at 2022 ASH Annual Meeting

- Poster with updated Phase Ib TOUCH results suggest selinexor plus GemOx could provide a therapeutic option for heavily pre-treated Stage III/IV patients with relapsed/refractory (R/R) T and NK-cell lymphoma
- Online abstract with results from the open-label LAUNCH study demonstrated the encouraging efficacy of selinexor in combination with dexamethasone and chemotherapy in relapsed/refractory multiple myeloma (R/R MM) patients including high-risk cytogenetic abnormalities

SHANGHAI and HONG KONG, Nov. 6, 2022 /PRNewswire/ -- 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 hematology and oncology, today announced that it will present updated results from the Phase Ib TOUCH study of selinexor for treatment of R/R T and NK-cell lymphoma in a poster at the upcoming 2022 American Society of Hematology (ASH) Annual Meeting. In addition, preliminary results from the investigator-initiated LAUNCH trial will be published in an on-line abstract. The 2022 ASH Annual Meeting will be held virtually and in person in New Orleans, Louisiana, the United States, from December 10-13, 2022.

"The data to be presented at ASH 2022 highlights the broad clinical potential and manageable side effect profile of selinexor in patients with well-defined T-cell lymphomas and R/R MM," said Dr. Jay Mei, Antengene's Founder, Chairman and CEO. "It is our great pleasure to share these updates with the hematology/oncology community at ASH 2022."

Poster Presentation

Title: XPO1 Inhibitor (ATG-010) Plus GemOx Regimen for Heavily Pretreated Patients with Relapsed or Refractory (R/R) T and NK-Cell Lymphoma: Update of the Phase Ib Touch Study
Abstract #: 2916
Date: December 11, 2022
Date and Time: 6:00 PM - 8:00 PM, ET / December 12, 2022, 7:00 AM – 9:00 AM, Beijing Time

The Phase Ib TOUCH study was designed to evaluate safety and efficacy of selinexor plus chemotherapy in patients with R/R T and NK-cell lymphoma. Antengene will report cumulative safety and efficacy data of  35 patients in the GemOx arm followed up for a median of 13 months and up to 22 months. Around 83% of the patients were clinically staged at III/IV, with a median of 3 lines of prior therapies. Disease subtypes included 15 PTCL-NOS (peripheral T-cell lymphoma, not otherwise specified), 10 ENKTL (extranodal NK/T-cell lymphoma), 9 AITL (angioimmunoblastic T-cell lymphoma) and 1 ALCL (anaplastic large cell lymphoma).

Treatment with ATG-010 plus GemOx demonstrated a manageable safety profile, and favorable efficacy especially in patients with PTCL-NOS and ENKTL. These data suggest that the combination of selinexor and GemOx could represent a new therapeutic option for this heavily pre-treated patient population.

From a safety perspective, treatment-emergent adverse events (TEAEs) were primarily hematological in nature and manageable by dose modification and supportive care. Among the 35 efficacy evaluable patients in the GemOx arm, overall response rate (ORR) was ~49% and complete response (CR) rate was 23%. At a median follow-up of 13 months, median progression-free survival (PFS) was 2.9 months and overall survival (OS) was not yet reached. Data for patients in the PTCL-NOS and ENKTL cohorts were relatively encouraging with a higher ORR of 53% and 60%, and a median PFS of 4.4 and 4.7 months, respectively.

Online Abstract Publication

Title: Preliminary Results from the Launch Study - a Multicenter, Open-Label Study of Selinexor, Dexamethasone and Chemotherapy Drugs in Relapsed/Refractory Multiple Myeloma

The LAUNCH study is a multi-center, open-label study to evaluate selinexor, dexamethasone and chemotherapy in patients with R/R MM who had at least one prior round of treatment. The abstract published data as of the July, 2022 abstract deadline, for 20 patients including 7 who had high-risk cytogenetic abnormalities. Overall, the combination showed encouraging efficacy and manageable safety and support longer term studies.

Among the 18 efficacy evaluable patients, the ORR was ~56% including 1 very good partial response (VGPR), 9 partial responses (PRs) and 5 stable diseases (SDs). Adverse events were reported in about 45-60% of patients and fell into two groups: hematological (~20-25% >Grade 3) and systemic (vomiting, fatigue and nausea, ~0-10% >Grade 3).

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 broad and expanding pipeline of 15 clinical and preclinical assets, of which 10 are global rights assets, and 5 came with rights for Asia Pacific markets including the Greater China region. To date, Antengene has obtained 26 investigational new drug (IND) approvals in the U.S. and Asia, and submitted 6 new drug applications (NDAs) in multiple Asia Pacific markets, with the NDA for XPOVIO^® (selinexor) already approved in mainland China, Taiwan, South Korea, Singapore and Australia.

Forward-looking statements

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For more information, please contact:

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SOURCE Antengene Corporation Limited