China Approves XPOVIO for Second-Line Multiple Myeloma Treatment Based on Phase III BENCH Trial
核心洞察
China's NMPA has approved XPOVIO (selinexor) in combination with bortezomib and dexamethasone for adult multiple myeloma (搜索) patients who have received at least one prior therapy.
The approval is based on the Phase III BENCH trial involving 154 Chinese patients, which demonstrated superior efficacy compared to standard bortezomib-dexamethasone treatment.
XPOVIO is the world's first approved orally-available selective XPO1 (搜索) inhibitor and marks the third approved indication for the drug in China.
The China National Medical Products Administration (搜索) (NMPA) has approved XPOVIO (selinexor) in combination with bortezomib and dexamethasone (XVd) for the treatment of adult patients with multiple myeloma (搜索) who have received at least one prior therapy. This marks the third approved indication for the drug in China, following previous approvals for relapsed/refractory diffuse large B-cell lymphoma (搜索) as monotherapy and relapsed/refractory multiple myeloma in combination with dexamethasone.
BENCH Trial Demonstrates Superior Efficacy
The approval is based on data from the BENCH trial, a randomized, controlled, open-label, multicenter Phase III bridging study that compared the safety and efficacy of XVd and Vd regimens in 154 Chinese patients with relapsed/refractory multiple myeloma (搜索) who had received one to three prior lines of therapy.
Results from the BENCH study showed clear superiority of the XVd regimen compared to the Vd regimen (bortezomib in combination with dexamethasone). The XVd combination demonstrated better clinical efficacy, longer progression-free survival (PFS) and duration of response (DOR), a higher objective response rate (ORR), a higher rate of very good partial response (VGPR) or deeper responses, minimal residual disease (MRD) negativity, and a trend of prolonged overall survival (OS).
The study observed particularly notable efficacy in elderly patients aged 65 and older, validating XPOVIO as a better treatment option for this patient population. The efficacy and safety data from the BENCH study were generally consistent with those from the global, multicenter Phase III BOSTON study.
Clinical Expert Perspectives
Prof. Jin Lu, principal investigator of the BENCH study from Peking University People's Hospital, emphasized the clinical significance: "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 from Shanghai Jiaotong University School of Medicine Affiliated Renji Hospital highlighted the unmet medical need: "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."
Novel Mechanism and Market Access
XPOVIO is the world's first approved orally-available, selective XPO1 (搜索) inhibitor with a novel mechanism of action. The drug has already been approved in ten countries and regions in the Asia-Pacific region and has been included in national insurance schemes in five markets: mainland China, Taiwan, Australia, Singapore, and South Korea.
Two of the three approved indications of XPOVIO in China—as monotherapy for relapsed/refractory diffuse large B-cell lymphoma (搜索) and in combination with dexamethasone for relapsed/refractory multiple myeloma (搜索)—have already been included in China's National Reimbursement Drug List.
Future Development Plans
Antengene is expanding the indications of XPOVIO by leveraging the drug's novel mechanism of action. The company is currently developing multiple combination regimens of XPOVIO for the treatment of various indications including myelofibrosis (搜索) and endometrial cancer (搜索).