The European Commission (EC) has granted conditional marketing authorization for selinexor, a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) medicine, in combination with dexamethasone for the treatment of myeloma in adult patients who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, two immunomodulatory agents, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
Conditional marketing authorization is supported by data from the positive Phase 2b STORM study, which evaluated selinexor in adult patients with heavily pretreated, triple class refractory multiple myeloma and was published in the New England Journal of Medicine. Under the provisions of conditional approval by the EC, continued authorization for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial and is subject to additional monitoring. An EC marketing authorization through the centralized procedure (CP) is valid in all 27 European Union (EU) member countries, as well as the European Economic Area (EEA) countries of Iceland, Liechtenstein and Norway.
About the Phase 2b STORM Pivotal Trial
The Phase 2b STORM trial (Selinexor Treatment of Refractory Myeloma) was an international, multi-center, single-arm, open-label study which enrolled 123 adult patients (Part 2 of the trial) with heavily pretreated, triple class refractory myeloma. Adult patients in the trial had a median of seven previous therapeutic regimens, including a median of 10 unique anti-myeloma agents.
For the study’s primary endpoint, oral selinexor achieved an overall response rate of 26% and the trial therefore met its primary endpoint. Minimal response per International Myeloma Working Group (IMWG) criteria was observed in 13% of the patients and 39% had stable disease.
A secondary efficacy endpoint included overall survival (OS), defined as the duration from start of study treatment to death due to any cause. The median OS was 8.6 months in the total population studied and 15.6 months in adult patients who had a minimal response or better.