Antengene Announces XPOVIO® Approved by the TGA in Australia for the Treatment of Relapsed and/or Refractory Multiple Myeloma and Triple Class-Refractory Multiple Myeloma

-  XPOVIO^®, in combination with bortezomib and dexamethasone (XBd), gives patients with relapsed and/or refractory multiple myeloma, a new treatment option.

-  XPOVIO^®, in combination with dexamethasone (Xd), gives patients with triple class refractory multiple myeloma, a new treatment option.  These patients have poor prognosis and limited treatment options.

-  XPOVIO^® is the first of a new class of SINE (selective inhibitor of nuclear export) medicines.

-  Multiple myeloma accounts for about 10% of all blood malignancies and 1.6% of all cancers in Australia^[1].

-  In Australia there is a substantial need for more multiple myeloma treatment options – survival rate is 53% at five years post diagnosis^[2].

-  In Australia around 2,400 people are diagnosed each year with multiple myeloma (MM), and around 20,000 patients are living with MM at any given time^[3].  Unfortunately, more than 1000 patients will die from this form of blood cancer in any given year  and therefore new treatment options such as XPOVIO^® are needed. 

SHANGHAI and HONG KONG, March 9, 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 therapeutics in hematology and oncology, today announced that the Therapeutic Goods Administration (TGA) of the Australian Government Department of Health has registered XPOVIO^® (selinexor) for two indications: (1) In combination with bortezomib and dexamethasone (XBd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy and (2) in combination with dexamethasone (Xd) for the treatment of adult patients with relapsed and/or refractory multiple myeloma (R/R MM) who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory medicinal product (IMiD), and an anti-CD38 monoclonal antibody (mAb).

XPOVIO^® is the first and only SINE approved by the TGA that helps to restore the body's own tumour suppressor pathways^[4].

Professor Hang Quach, Haematologist at St Vincent's Hospital, Melbourne, commented, "I was privileged to be one of the investigators in the BOSTON clinical study and have since co-authored on a few papers on the XBd regimen. This triplet regimen is no doubt in my mind amongst the most effective therapies for early relapse in the era of lenalidomide refractoriness. On subset analyses, this triplet regimen is effective irrespective of age, frail or non-frail patients and is effective in patients with low creatinine clearance.  Importantly, XBd combination was particularly effective in patients with high-risk cytogenetics.

Professor Hang Quach further commented "I believe that the first three lines of therapy for MM are the most important in dictating a patient's overall survival because the majority of patients with MM in the real-world setting will not live to see fourth line of treatment or beyond. Moreover, the greatest clinical benefit is gained when an effective treatment is used in early-line relapse. It is therefore important that the clinician be given enough choice in that "one to three prior line" space to allow the most optimal regimen to be used based on a patient's clinical profile. The lack of sufficient choices for lenalidomide-refractory patients in early-line relapse of MM is an area of unmet need in Australia. The availability of XPOVIO^®, bortezomib and dexamethasone as an option in this space will address this unmet need."

"In Australia, one critical area of unmet need for patients with myeloma is the lack of effective therapies for patients who are triple-class refractory, that is refractory to a proteasome inhibitor, immunomodulatory drug and an anti-CD38 monoclonal antibody. The benefit of XPOVIO^® is that it is an oral drug with a completely novel mechanism of action which makes it ideal for triple-class refractory patients. XPOVIO^® can induce responses and prolong life in a clinically meaningful way", said Professor Andrew Spencer, Haematologist, Alfred Hospital, Melbourne.

Hayley Beer, Interim Co-CEO of Myeloma Australia, said "It is very important to have another treatment option for people living with multiple myeloma, in both earlier and later lines of therapy. XPOVIO^® is a new class of drug with a unique mode of action, so it means that patients can try a new combination without necessarily recycling a previously used class of drug."

"This is a significant milestone for Antengene and for MM patients in Australia. We are very pleased to be launching XPOVIO^® and bring to Australian physicians and patients a novel addition to their existing regimens for the treatment of R/R MM. As our first product to be registered in Australia, it also marks the evolution of Antengene in Australia into a biopharmaceutical organization with a commitment to continued development and commercialization of transformational medicines for cancer and other life-threatening diseases in Australia," said Thomas Karalis, CVP Asia Pacific of Antengene.

"The series of approvals granted to XPOVIO^® in China, South Korea, Singapore and now Australia in the past six months have indicated the drug's enormous therapeutic potential. In Australia, there are around 2,400 diagnosed cases of MM every year, thus presenting an urgent unmet clinical need in the treatment of MM," said Jay Mei, Antengene's Founder, Chairman and CEO. "This approval by the TGA is practice-changing for patients in Australia who have long suffered from MM. We are committed to bringing innovative drugs and therapies to patients with cancer or other life-threatening disease in the Asia Pacific region and around the world. Now, our commercial team is well prepared to further extend patients' access to this novel therapy, building upon our commercialization experience with XPOVIO^® launches in China, Singapore and South Korea."

About XPOVIO^®/ATG-010/Selinexor

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.  Due to its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens to improve treatment efficacy.

Selinexor is approved by the US FDA for the treatment of R/R MM and R/R DLBCL.

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 also secured approval for selinexor in South Korea for use in R/R MM and R/R DLBCL in July 2021, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM in March 2022. Antengene is conducting 10 studies in mainland China (3 in collaboration with Karyopharm) 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 22 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.

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