Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematologic malignancies and solid tumors, today announced that the China National Medical Products Administration (NMPA) has approved XPOVIO® (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy, a new indication of XPOVIO®.

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.

Source: prnewswire.com