Stemline B V — Nexpovio EMA EPAR public assessment report (EMEA/H/C/005127, 2021)
Stemline B V · 2021 · EMA EPAR public assessment report
Report summary
The EMA assessed Nexpovio (selinexor), an oral XPO1 inhibitor, for relapsed/refractory multiple myeloma (RRMM) in patients who received at least three prior therapies. Granted accelerated assessment due to unmet medical need, the application sought conditional marketing authorization. Quality aspects of the tablets, including manufacturing and impurity control, were deemed acceptable. Non-clinical studies showed efficacy in cancer models but also significant toxicity. Clinical trials (KCP-330-001, KCP-330-009, KCP-330-010) investigated selinexor in various hematologic malignancies, providing pharmacokinetic data. Efficacy and safety of selinexor plus dexamethasone were evaluated. The STORM study (KCP-330-012) in penta-refractory multiple myeloma showed an overall response rate of 25.3% and median overall survival of 8.4 months. The safety profile, characterized by high rates of Grade 3+ adverse events (e.g., thrombocytopenia), was considered manageable in this heavily pre-treated population. Conditional marketing authorization was granted, with confirmatory data expected from the BOSTON study.
Key findings — cited to the page
| Grade 3+ thrombocytopenia incidence | 139 patients | · p.105 |
| Grade 3+ hyponatraemia incidence | 50 patients | · p.105 |
| patients with at least 1 Grade 4 TEAE | 99 patients | · p.105 |
| percentage of patients with at least 1 Grade 5 TEAE | 9.3 % | · p.105 |
| Grade 3+ anaemia incidence | 94 patients | · p.105 |
| Grade 3+ anaemia incidence | 43.9 % | · p.105 |
| patients with at least 1 Grade 3+ TEAE | 205 patients | · p.105 |
| percentage of patients with at least 1 Grade 3+ TEAE | 95.8 % | · p.105 |
| percentage of patients with at least 1 Grade 4 TEAE | 46.3 % | · p.105 |
| patients with at least 1 Grade 5 TEAE | 20 patients | · p.105 |
| Grade 3+ thrombocytopenia incidence | 65 % | · p.105 |
| Grade 3+ hyponatraemia incidence | 23.4 % | · p.105 |
Source: Stemline B V ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →