Stemline B V — Nexpovio EMA EPAR variation assessment report (EMEA/H/C/005127, 2021)

Report summary

This report details a Type II variation application for Nexpovio (selinexor) to add a new therapeutic indication for relapsed/refractory multiple myeloma in combination with bortezomib and dexamethasone (SVd). The application is supported by the Phase 3 BOSTON study (KCP-330-023), which compared SVd to bortezomib and dexamethasone (Vd). The BOSTON study demonstrated a statistically significant improvement in median progression-free survival (PFS) and a higher overall response rate (ORR) for the SVd arm. While SVd showed improved efficacy, it was associated with higher rates of certain adverse events, including Grade ≥3 TEAEs, thrombocytopenia, nausea, and fatigue. Conversely, peripheral neuropathy was more frequent in the Vd arm. Despite the increased toxicity, the report concludes with a positive benefit-risk balance for SVd, recommending approval for the expanded indication. The report also covers pharmacokinetic properties, study design, statistical methods, and addresses regulatory concerns regarding data integrity.

Key findings — cited to the page