Antengene Announces XPOVIO® Approved in China for the Second-Line Treatment of Multiple Myeloma, Marking the Third Approved Indication of the Drug
This approval for XPOVIO ® is based on the data of the BENCH trial, a randomized, controlled, open-label, multicenter Phase III bridging study which compared the safety and efficacy of XVd and Vd regimens in 154 Chinese patients with R/R MM who have received one to three prior lines of therapy. The efficacy and safety data of the BENCH study are generally consistent with those from the global, multicenter, Phase III BOSTON study and met the objectives of the bridging study which showed:
Clear superiority of the XVd regimen: compared to the Vd regimen, the XVd regimen demonstrated better clinical efficacy, longer PFS and DOR, a higher ORR, a higher rate of very good partial response (VGPR) or deeper responses and minimal residual disease (MRD) negativity, as well as a trend of prolonged OS.
Notable clinical benefits for elderly patients: the study observed particularly notable efficacy in the cohort of elderly patients aged ≥65, validating XPOVIO ® as a better treatment option for this patient population.
Prof. Jin Lu, principal investigator of the BENCH study from Peking University People ' s Hospital, said, "MM is the second most common hematologic malignancy. The clinical application of autologous hematopoietic stem cell transplantation (ASCT) and novel agents in the first-line setting have resulted in longer overall survival for patients. However, the condition remains incurable with most patients end up relapsing. As a novel inhibitor of the nuclear export protein that adopts a novel mechanism of action, selinexor was proven by the BENCH study to be significantly efficacious in Chinese patients with MM. This approval for XPOVIO ® is a great news for patients with R/R MM, especially those relapsing for the first time."
Prof. Jian Hou, principal investigator of the BENCH study from Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital, commented, "The incidence of MM has been steadily rising year after year. According to the Globocan statistics for 2022, there were 30,300 new cases of MM and 18,662 MM related deaths in China, a figure that highlights an urgent unmet clinical need. Selinexor in combination with bortezomib and dexamethasone incorporates a unique mechanism of action and demonstrated significant efficacy. Moreover, XPOVIO ® does not require intravenous administration, therefore provides clinicians a new treatment strategy that can effectively reduce burden on patients."
With a novel mechanism of action, XPOVIO ® is the world's first approved orally-available, selective XPO1 inhibitor, which has already been approved in ten countries and regions in APAC, and has been included in the national insurance schemes in five of these markets (the mainland of China, Taiwan market, Australia, Singapore and South Korea).
While bringing XPOVIO ® to more APAC markets, Antengene is also striving to expand the indications of XPOVIO ®. Leveraging the drug's novel mechanism of action, Antengene is currently developing multiple combination regimens of XPOVIO ® for the treatment of various indications including myelofibrosis (MF) and endometrial cancer.
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".
Antengene has built a pipeline of 9 oncology assets at various stages going from clinical to commercial, including 6 with global rights, and 3 with rights for the APAC region. To date, Antengene has obtained 31 investigational new drug (IND) approvals in the U.S. and Asia, and submitted new drug applications (NDAs) in 11 Asia Pacific markets, with the NDA for XPOVIO ® (selinexor) already approved in Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia.
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. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2024, and the documents subsequently submitted to the Hong Kong Stock Exchange.
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