Instant Report

Date: 06-Jan-2021

Antengene Seeks South Korean MFDS Approval For Selinexor To Treat RrMM And RrDLBCL

Antengene Corporation Limited, a leading innovative biopharmaceutical company, 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 US 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.”

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., 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).

Antengene Corporation Limited is a leading clinical-stage Asia-Pacific biopharmaceutical company focused on innovative oncology medicines.