Antengene Announces XPOVIO® (selinexor) Data to be Presented at the Upcoming 2022 European Hematology Association Hybrid Congress

May 14, 2022View PDF

Shanghai and Hong Kong, PRC, May 13, 2022 — 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 therapeutics in hematology and oncology, announces that an abstract related to XPOVIO® (selinexor) has been selected for presentation at the upcoming 2022 European Hematology Association (EHA2022) Hybrid Congress taking place from June 9-12, 2022 in Vienna, Austria in person or via virtual attendance: https://ehaweb.org/congress/eha2022-hybrid/eha2022-congress/

 

The abstract highlights encouraging activity of selinexor plus low-dose dexamethasone  combo (Sd regimen) in a small group of heavily pre-treated patients relapsed/refractory multiple myeloma (R/R MM) previously exposed to chimeric antigen receptor T-cell (CAR-T) therapy within the single-arm, Phase II, registrational MARCH study conducted in China.

 

“Antengene has made it a priority to focus on developing therapies for relapsed and refractory patients with cancer. We feel this is a particularly important medical need and we are glad that our science provides us with an opportunity to make a positive impact in this setting,” said Dr. Kevin Lynch, Antengene’s Chief Medical Officer. “We are excited to share this latest and very encouraging data on selinexor at the EHA2022. These data underscore our commitment to elaborating the clinical experience for selinexor and bringing new data to the oncology community.”

 

Details for the EHA2022 Hybrid Congress Presentation are as follows:

 

Title: ATG-010 plus low-dose dexamethasone (SD) in Chinese relapsed/refractory multiple myeloma (RRMM) patients previously received chimeric antigen receptor T-cell (CAR-T)

Abstract #: PB1999

 

The abstract highlights the results of a small group of patients (n=10) from the single-arm, Phase II registrational, 82-subject MARCH study of the Sd regimen in Chinese patients, with R/R MM all previously treated with CAR-T therapy. Patients were heavily pre-treated, having received a median of 9.5 prior regimen (range 5-12), with a median time from initial diagnosis of 5.2 years. The group included 6 patients with high-risk cytogenetic abnormalities.

 

Of the 10 patients in the group, 5 experienced very rapid disease progression, measured by a 42% increase in tumor burden from screening to Cycle 1. Adverse events were consistent with those events previously reported with the Sd regimen in MM patients. The overall response rate (ORR) was 50% including 1 very good partial response (VGPR) and 4 partial responses (PRs). Disease control, defined as stable disease (SD) and above, was 70%. As of February 10, 2022, all patients had disease progression, with 5 patients under survival follow-up. The median duration of response was 1.4 months (95% VI: 0.96) and the median progression free survival was 1.9 months (95% CI: 0.93, 3.74). Median overall survival was not reached and the estimated 12-month Overall Survival (OS) rate was 70%.

 

The authors noted that the Sd regimen preserves anti-tumor activity regardless of prior therapies and classified the results in these heavily pre-treated patients as encouraging.

 

About Multiple Myeloma

Multiple Myeloma (MM) is the second most common hematological malignancy in China, with approximately 15,000 to 20,000 new MM patients and 10,300 deaths per year.1

 

About XPOVIO® (selinexor)

XPOVIO® is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL).  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.  Based on its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens in hematological and solid tumor cancers to improve treatment efficacy.

 

Antengene secured approval of selinexor in China in December 2021 for R/R MM and plans to launch the product in the second quarter of 2022. Antengene has also secured approval for XPOVIO® in South Korea for use in R/R MM and R/R DLBCL, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM. Antengene is conducting 10 clinical studies in mainland China (3 in collaboration with Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.

About Antengene

Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK) is a leading commercial-stage R&D-driven global biopharmaceutical company focused on innovative first-in-class/best-in-class therapeutic medicines for cancer 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 23 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/XPOVIO® in China, South Korea, Singapore and Australia approved. Leveraging partnerships as well as in-house drug discovery, Antengene has built a broad and expanding pipeline of 15 clinical and pre-clinical assets. Antengene has global rights on 10 programs and Asia Pacific rights, including the Greater China region, on 5 programs.

 

Forward-looking statements

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References:

1. Statistics released by the International Myeloma Foundation at https://www.myeloma.org/