Antengene Submits NDA for ATG-010 (Selinexor) in South Korea for rrMM and rrDLBCL

Rhea-AI Summary

On January 3, 2021, Antengene Corporation announced the submission of a New Drug Application (NDA) for ATG-010 (selinexor, XPOVIO^®) to the South Korean Ministry of Food and Drug Safety. The NDA, which includes Orphan Drug Designation, aims to treat relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma. The application is supported by positive results from pivotal studies STORM and SADAL. Antengene also filed NDAs in Singapore and Australia and highlights the urgency for innovative therapies in hematological malignancies.

Positive

• Successful NDA submission for ATG-010 in South Korea for rrMM and rrDLBCL.
• Supported by positive data from STORM and SADAL studies demonstrating efficacy.
• First-in-class oral medication with orphan drug designation and FDA approval.
• Expansion of treatment options in APAC markets enhances market potential.

Negative

• None.

SHANGHAI and HONG KONG, Jan. 3, 2021 /PRNewswire/ -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in class therapeutics in hematology and oncology, announced that it has submitted a New Drug Application (NDA) with Orphan Drug Designation (ODD) to the South Korean Ministry of Food and Drug Safety (MFDS) for ATG-010 (selinexor, XPOVIO^®) in combination with low dose dexamethasone for the treatment of adult patients with relapsed/refractory multiple myeloma (rrMM) and for ATG-010 (selinexor, XPOVIO^®) as monotherapy to treat adult patients with relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). ATG-010 (selinexor, XPOVIO^®) was granted orphan drug designation in South Korea in October 2020 and our US partner Karyopharm received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with multiple myeloma after at least one prior therapy on December 18, 2020.

The NDA submission includes positive data from the pivotal STORM and SADAL studies, which both demonstrated significant and meaningful efficacy with a manageable safety profile for ATG-010 (selinexor, XPOVIO^®). The STORM study is a Phase 2b, open-label, single-arm study evaluating ATG-010 (selinexor, XPOVIO^®) plus low-dose dexamethasone in patients with rrMM who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody. The SADAL study is a Phase 2b, open label study evaluating ATG-010 (selinexor, XPOVIO^®) in patients with rrDLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, who have received at least two prior therapies. 

ATG-010 (selinexor, XPOVIO^®) is a first-in-class and only-in-class oral selective inhibitor of nuclear export (SINE) and it is the first drug approved by the FDA for use in both multiple myeloma and diffuse large B-cell lymphoma. In December 2020, the National Comprehensive Cancer Network (NCCN^®) added three different triplet ATG-010 (selinexor, XPOVIO®) combination regimens, including SVd (selinexor, bortezomib and dexamethasone), SPd (selinexor, pomalidomide and dexamethasone) and SDd (selinexor, daratumumab and dexamethasone) to its Clinical Practice Guidelines in Oncology (NCCN^® Guidelines) for previously treated multiple myeloma in the US. Antengene has submitted NDAs to the Health Sciences Authority (HSA) of Singapore and to the Australian Therapeutic Goods Administration (TGA) for ATG-010 in patients with rrMM and in patients with rrDLBCL.

"The incidence of blood cancers increases with age, yet many healthcare providers still do not have sufficient innovative therapies available to help people with hematological malignancies, such as rrMM and rrDLBCL," Dr. Jay Mei, Founder, Chairman and CEO of Antengene said, "We are excited about the regulatory filing of ATG-010 in APAC markets, including South Korea. We believe that oral ATG-010 will expand and improve treatment options for hematological malignancies and therefore presents a significant advancement for patients requiring treatment of these life threatening diseases."

About ATG-010 (selinexor, XPOVIO®)

ATG-010 (selinexor, XPOVIO^®), a first-in-class and only-in-class oral selective inhibitor of nuclear export compound discovered and developed by Karyopharm Therapeutics Inc. (NASDAQ: KPTI), is currently being developed by Antengene, which has the exclusive development and commercial rights in certain Asia-Pacific markets, including the Greater China, South Korea, Australia, New Zealand and the ASEAN countries. In July 2019, the US Food and Drug Administration (FDA) approved selinexor (XPOVIO^®) in combination with low-dose dexamethasone for the treatment of relapsed/refractory multiple myeloma (rrMM) and in June 2020 approved selinexor (XPOVIO^®) as a single-agent for the treatment of relapsed/refractory diffuse large B-cell lymphoma (rrDLBCL). A Marketing Authorization Application (MAA) has also been submitted to the European Medicines Agency (EMA) with a request for conditional approval of selinexor (XPOVIO^®) in this same rrMM indication. On December 18, 2020, the supplemental New Drug Application (sNDA) with a request for an expansion of its indication to include the treatment for patients with multiple myeloma after at least one prior therapy was approved by the FDA. Selinexor (XPOVIO^®) is so far the first and only oral SINE compound approved by the FDA and is the first drug approved by the FDA for the treatment of both MM and DLBCL. Selinexor (XPOVIO^®) is also being evaluated in several other mid-and later-phase clinical trials across multiple solid tumor indications, including liposarcoma and endometrial cancer. In November 2020, at the Connective Tissue Oncology Society 2020 Annual Meeting (CTOS 2020), Antengene's partner, Karyopharm, presented positive results from the Phase 3 randomized, double blind, placebo controlled, cross-over SEAL study evaluating single agent, oral selinexor (XPOVIO^®) versus matching placebo in patients with liposarcoma. Karyopharm also recently announced that the ongoing Phase 3 SIENDO study of selinexor (XPOVIO®) in patients with endometrial cancer passed the planned interim futility analysis and the Data and Safety Monitoring Board (DSMB) recommended the study should proceed as planned without any modifications. Top-line SIENDO study results are expected in the second half of 2021.

Antengene is conducting two registrational Phase 2 clinical trials of ATG-010 (selinexor, XPOVIO^®) in China for relapsed/refractory multiple myeloma (MARCH) and for relapsed/refractory diffuse large B-cell lymphoma (SEARCH), and has initiated clinical trials for high prevalence cancer types in the Asia Pacific region including peripheral T-cell lymphoma and NK/T-cell lymphoma (TOUCH) and KRAS-mutant non-small cell lung cancer (TRUMP).

About Antengene

Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines. Antengene aims to provide the most advanced anti-cancer drugs to patients in China, the Asia Pacific Region and around the world. Since its establishment, Antengene has built a pipeline of 12 clinical and pre-clinical stage assets and obtained 11 investigational new drug approvals in Asia Pacific. The vision of Antengene is to "Treat Patients Beyond Borders". Antengene aims to address significant unmet medical needs by discovering, developing and commercializing first-in-class/best-in-class therapeutics.

Forward-looking statements

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

* XPOVIO^® is a registered trademark of Karyopharm Therapeutics Inc.;
NCCN^® is a registered trademark of National Comprehensive Cancer Network.

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SOURCE Antengene Corporation Limited

FAQ

What is the significance of Antengene's NDA submission for KPTI?

The NDA submission for ATG-010 (selinexor, XPOVIO) represents a significant advancement for Antengene in treating hematological malignancies, enhancing its market presence.

When was the NDA for ATG-010 submitted to the South Korean authorities?

The NDA for ATG-010 was submitted on January 3, 2021.

What studies support the NDA for ATG-010 submitted by Antengene?

The NDA is supported by positive results from pivotal studies STORM and SADAL, which showed significant efficacy.

What types of cancer is ATG-010 targeting in the NDA submission?

The NDA targets relapsed/refractory multiple myeloma and diffuse large B-cell lymphoma.

Has Antengene submitted NDAs for ATG-010 in other regions?

Yes, Antengene has also submitted NDAs to the Health Sciences Authority in Singapore and the Australian Therapeutic Goods Administration.