John Theurer Cancer Center Investigators Contribute to Knowledge Base on Selinexor Use
What You Need to Know
Investigators from Hackensack University Medical Center’s John Theurer Cancer Center are contributing to the growing knowledge base on the use of selinexor, a selective inhibitor of nuclear export (SINE), in the treatment of multiple myeloma (MM), as reported in three recent publications: Expert Review of Hematology, British Journal of Cancer and BMC Cancer.
These publications, which include a review article and reports from two clinical trials, further characterize the efficacy, safety, and mechanism of action (MOA) of selinexor as well as its impact on health-related quality of life (HRQOL) in patients with MM.
Expert Review of Hematology
Dr. Biran and David Siegel, M.D., of JTCC contributed to a review article published in Expert Review of Hematology, that provides an overview of the selinexor MOA, as well as efficacy and safety data from clinical studies using selinexor for the treatment of MM.
The review also summarizes data from the Selinexor Treatment of Refractory Melanoma (STORM), Selinexor and Backbone Treatments of Multiple Myeloma Patients (STOMP), and Bortezomib, Selinexor, and Dexamethasone (BOSTON) trials. These trials demonstrated safety and efficacy in patients with triple-class refractory as well as early relapsed MM.4
British Journal of Cancer
Dr. Biran is co-author of a British Journal of Cancer article reporting results from the ongoing Phase 1b/2 STOMP trial, which is investigating the safety and efficacy of once-weekly therapy with the selinexor-dexamethasone-carfilzomib (XKd) combination in 32 patients with RRMM not refractory to carfilzomib. The regimen was highly effective and well-tolerated, with an overall response rate of 78%, including 14 patients (44%) with at least very good partial responses. Common treatment-related adverse events included thrombocytopenia, nausea, anemia, and fatigue, all of which were expected and manageable with supportive care and dose modifications. The investigators identified the maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) as selinexor 80 mg, carfilzomib 56 mg/m2, and dexamethasone 40 mg, all once weekly.5
BMC Cancer
Drs. Biran and Siegel were co-investigators in a quality-of-life analysis of 80 participants in the STORM trial, a Phase 2b, single-arm, open-label, multicenter study of selinexor with low-dose dexamethasone in patients with penta-exposed RRMM. As reported in BMC Cancer, a majority of participants did not experience a decline in HRQOL based on minimal clinically important differences (the smallest meaningful improvement in the score of a patient-reported outcomes PRO domain, interpreted as a minimum level of perceived benefit by patients) during early cycles of treatment. Treatment responders experienced less decline in HRQOL from baseline to end of treatment than did non-responders; this finding was significant for the General version of the Functional Assessment of Cancer Therapy (FACT-G) instrument, but not for other measures.6