OncLive reports that the FDA’s Oncologic Drugs Advisory Committee (ODAC) rejected Karyopharm Therapeutics’ request for accelerated approval of selinexor for myeloma patients who have received received ≥3 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-targeted antibody, and to their most recent treatment. Rather, the FDA is recommending to delay any final decision until the results from a Phase III BOSTON trial are ready.
The BOSTON trial, sponsored by Karyopharm Therapeutics, is a Phase 3, 2-arm, randomized, active comparator-controlled, open-label, multicenter study. It will compare the efficacy and health-related quality of life (HR-QoL), as well as assess the safety of selinexor plus bortezomib (Velcade®) plus low-dose dexamethasone (SVd), versus bortezomib plus low-dose dexamethasone (Vd) in adult patients with RRMM who have received 1 to 3 prior anti-multiple myeloma (MM) regimens. Crossover from the Vd Arm to a treatment that includes selinexor (i.e., SVdX or SdX) will be allowed at the point of IRC-confirmed objective disease progression per the IMWG criteria for patients in the Vd Arm.
Involving 364 patients, it is scheduled to be complete in 2020. The study includes prominent research sites worldwide.