Selinexor combined with Vd receives European marketing authorization for RRMM

Following the positive opinion granted by the Committee for Medicinal Products for Human Use (CHMP) in May 2022,¹ selinexor in combination with bortezomib and dexamethasone (SVd) has received European marketing authorization for the treatment of patients with relapsed/refractory multiple myeloma.² This approval is been based on results from the randomized phase III BOSTON trial (NCT03110562), which were reported in the Lancet in November 2020³ and previously discussed by the Multiple Myeloma Hub here.

Selinexor is an oral, first-in-class, exportin 1 (XPO1) inhibitor, which through the BOSTON trial has been shown to be safe and efficacious in the treatment of patients with relapsed/refractory multiple myeloma who have received 1–3 prior courses of treatment.²

With a total of 402 patients enrolled, the BOSTON trial met its primary endpoint and demonstrated that once-weekly SVd resulted in a statistically significant reduction in the risk of disease progression or death when compared to standard twice-weekly bortezomib plus dexamethasone (Vd).³ The median progression-free survival in the SVd arm was 13.93 months compared with 9.46 months in the Vd arm (hazard ratio, 0.70; p = 0.0075).³ The most frequent Grade 3/4 adverse events seen with VRd treatment were thrombocytopenia, anemia, and fatigue. SVd was considered well-tolerated, with adverse events that were manageable and reversible.