EHA24 Congress: Selinexor With Daratumumab and Dexamethasone in Resistant Myeloma
Posted: Thursday, July 11, 2019
For patients with relapsed or refractory multiple melanoma, findings presented at the 2019 European Hematology Association (EHA) Annual Meeting in Amsterdam (Abstract S1606) indicate that the first-in-class selective inhibitor selinexor may be safely combined with daratumumab and dexamethasone to “produce a deep and durable response.” Cristina Gasparetto, MD, of the Duke University Cancer Center, Durham, North Carolina, and colleagues determined that the triplet regimen given once weekly improved overall response rates for patients and warrants further studies.
This multicenter, open-label, phase I/IIb study enrolled 30 patients (16 men and 14 women) who had previously received 3 or more lines of antimyeloma therapy. Selinexor was dose-escalated in two concurrent cohorts, with 27 patients receiving the dose once weekly and 3 patients receiving selinexor twice weekly. The investigators administered daratumumab at 16 mg/kg or dexamethasone at 40 mg once a week or 20 mg every 2 weeks.
Of the patients enrolled in the study, 28 were evaluable for response. Patients who were daratumumab-naive (26 patients) displayed an overall response rate of 77%, with 9 very good partial responses, 8 partial responses, and 3 unconfirmed partial responses. For the two patients who were treated with daratumumab and had refractory multiple myeloma, the authors observed one case of progressive disease and one case of stable disease.
Common all-grade treatment-related adverse events reported among the patients were thrombocytopenia (66%), nausea (66%), fatigue (55%), anemia (52%), leukopenia (48%), and neutropenia (48%). The investigators discovered two dose-limiting toxicities in the 60-mg twice-weekly cohort of patients: grade 3 thrombocytopenia and grade 2 fatigue requiring dose reduction. The authors did not find dose-limiting toxicities among the patients receiving 100 mg of selinexor once a week.
Disclosure: The study authors’ disclosure information may be found at ehaweb.org.
