STORM Trial: Oral Selinexor Combination in Refractory Myeloma
Posted: Thursday, December 5, 2019
When used with low doses of dexamethasone, the selective inhibitor selinexor yielded objective treatment responses in patients diagnosed with refractory myeloma, according to the findings from the phase IIb STORM trial reported in The New England Journal of Medicine. Ajai Chari, MD, of the Icahn School of Medicine at Mount Sinai Hospital, New York, and colleagues noted that the results of the study were particularly meaningful because the specific characteristics of the patients involved—heavily pretreated but still experiencing rapidly progressive disease—are in line with a growing population of patients.
“Despite the availability of proteasome inhibitors, immunomodulatory drugs, alkylating agents, and monoclonal antibodies for the treatment of multiple myeloma, most patients will, regrettably, have disease that continues to progress,” said study coauthor Paul G. Richardson, MD, of the Dana-Farber Cancer Institute, Boston, in a press release. “An increasing number of patients are developing highly refractory disease and have no remaining treatment options of known clinical benefit.”
In this trial, the investigators enrolled 122 patients from the United States and Europe who had myeloma and had previously been exposed to bortezomib, carfilzomib, lenalidomide, pomalidomide, daratumumab, and an alkylating agent. The patients had disease that was refractory to at least one proteasome inhibitor, one immunomodulatory agent, and daratumumab. The patients were given 80 mg of selinexor plus 20 mg of dexamethasone twice weekly.
A total of 26% of the patients experienced a partial response or better—including two stringent complete responses—and 39% experienced a minimal response or better. The median duration of response was 4.4 months, the median progression-free survival was 3.7 months, and the median overall survival was 8.6 months.
The most common grade 1 or 2 adverse events were fatigue, nausea, and decreased appetite. A total of 25% of patients reported grade 3 events, and no patients reported grade 4 adverse events.
Disclosure: For full disclosures of the study authors, visit nejm.org.
