Therapeutic efficacy of Selinexor

Selinexor Combination with Bortezomib and Dexamethasone (XVd).

The efficacy of Selinexor in combination with bortezomib and dexamethasone was evaluated in BOSTON(NCT03110562). BOSTON was a global, randomized, open label, active-controlled trial in adult patients whohad received 1 to 3 prior anti-MM regimens. Prior treatment with bortezomib or other PI was allowed.Patients with Grade 2 or higher peripheral neuropathy at study entry were excluded. 

Patients were randomized to receive one of the following: 

Selinexor 100 mg orally once weekly on Days 1, 8, 15, 22, 29 in combination with bortezomib 1.3 mg/m2administered subcutaneously once weekly on Days 1, 8, 15, 22 and dexamethasone 20 mg taken orallytwice weekly on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle [XVd arm] or 

Bortezomib 1.3 mg/m2 administered subcutaneously twice weekly on Days 1, 4, 8, 11 and dexamethasone 20 mg taken orally four times weekly on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for the first 8 cycles, followed by bortezomib1.3 mg/m2 administered subcutaneously once weekly on Days 1, 8, 15, 22 and dexamethasone 20 mg taken orally twice weekly on Days 1, 2, 8, 9, 15, 16, 22, 23, 29, and 30 of each 35-day cycle (Cycle ≥9) [Vd arm].

from FDA，2022.07