Updated data from a Phase 2b clinical trial, SADAL, assessing Karyopharm Therapeutics' (KPTI) lead product candidate selinexor (KPT-330) for the treatment of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) showed a 33.3% (n=21/63) response rate. The results are being presented at the European Hematology Association Annual Meeting in Madrid.
The response rate included nine complete responders and 12 partial responders. Including six patients with stable cancer, the disease control rate was 42.9% (n=27/63). Median duration of response across all patients was greater than seven months.
Median overall survival (OS) was eight months for all patients, slightly better than published survival data of six-to-seven months for this population. Median OS in the responder groups has not been reached, but it is now greater than nine months.
The most common adverse events were: fatigue (61%), nausea (51%), thrombocytopenia (50%), anorexia (49%), vomiting (31%) and anemia (30%). The most common grade 3 (serious) and grade 4 (life-threatening) adverse events in the 60 mg arm were thrombocytopenia (28%), neutropenia (17%), anemia (15%) and fatigue (11%). All were manageable with dose modifications and/or standard supportive care.
According to ClinicalTrials.gov, the study's primary completion date is March 2018.
Selinexor is a SINE (Selective Inhibitor of Nuclear Export) compound. It binds to and inhibits the nuclear export protein XPO1 which leads to the accumulation of tumor suppressor proteins in the cell nucleus which amplifies tumor suppression.
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