EHA 2018: First-in-Class Selinexor in Combination Therapy for Resistant Multiple Myeloma
Posted: Monday, June 25, 2018
The combination of selinexor, a first-in-class selective inhibitor of nuclear export (SINE), daratumumab, and low-dose dexamethasone may prove to be an effective treatment with an acceptable safety profile for patients with relapsed or refractory multiple myeloma, according to the preliminary results of the STOMP trial. Cristina Gasparetto, MD, of Duke University in Durham, North Carolina, and colleagues presented their findings at the 2018 European Hematology Association (EHA) Annual Congress in Stockholm (Abstract PS1329).
The phase Ib dose escalation study enrolled 21 patients with relapsed or refractory multiple myeloma who had received at least 3 prior therapies, including a protease inhibitor and an immunomodulatory drug. Oral selinexor was dose-escalated either once weekly at 100 mg or twice weekly at 60 mg, along with daratumumab weekly and dexamethasone weekly or twice weekly.
The overall response rates in all 19 evaluable participants and the 17 daratumumab-naive patients were 74% and 82%, respectively. Responses were seen at a median of 1 month from the initiation of therapy. The most common grade 1 and 2 adverse events observed were nausea (48%) and fatigue (38%); the most common grade 3 and 4 adverse events were thrombocytopenia (48%), leukopenia (43%), anemia (33%), and neutropenia (33%). The maximum tolerated dose was not reached.
Based on tolerability and efficacy, the recommended phase II dosing schedule is selinexor at 100 mg weekly, daratumumab at 16 mg/kg of body weight weekly, and dexamethasone at 40 mg weekly. At the time of the study presentation, the researchers were still enrolling participants in the recommended treatment arm.
