Safety of Selinexor with R-GDP Established in Early Study of Regimen in R/R B-cell Lymphoma

By Leah Lawrence - Last Updated: December 8, 2022

Selinexor in combination with rituximab, gemcitabine, cisplatin, and dexamethasone (R-GDP) appears to have encouraging activity in patients with relapsed or refractory (R/R) B-cell lymphoma, according to final results from the SELINDA phase Ib Lysa study.

Advertisement

Marie Maerevoet, of the Institut Jules Bordet in Brussels, Belgium, and colleagues published the updated data during the 2022 American Society of Hematology Annual Meeting.

Selinexor is an “oral selective inhibitor of nuclear export which, through XPO1 blockade, causes nuclear accumulation and activation of tumor suppressor proteins, reduction in oncoproteins and cancer cell apoptosis,” the authors noted.

The phase Ib SELINDA study assessed the safety and efficacy of selinexor in patients aged younger than 70 years who were diagnosed with R/R B-cell lymphoma after first or second treatment failure. Enrolled patients received R-GDP in combination with escalating doses of selinexor.

The dose-escalation study established the recommended phase II dose as 40 mg on days one, eight, and 15. The researchers focused their data reporting on the 18 patients who received the recommended dose: 15 had diffuse large B-cell lymphoma, two had follicular lymphoma, and one has marginal zone lymphoma.

The overall response rate was 67%. Complete molecular response occurred in 39% of patients. Partial metabolic response occurred in 28%, and 28% of patients had stable or progressive disease.

Four patients who received the recommended phase II dose underwent high-dose therapy and autologous hematopoietic stem cell transplantation.

The one-year overall survival was 72.2%, with a one-year progression-free survival of 45%. Median duration of response was not reached.

Four patients discontinued therapy ahead of schedule; two of these patients had thrombocytopenia, one had COVID-19, and one had disease progression. The most common adverse events were reversible neutropenia (55%), thrombocytopenia (44%), and nausea (22%).

According to the researchers, there is an ongoing phase II study comparing R-GDP with or without selinexor.

Reference

Maerevoet M, Casasnovas O, Carton G, et al. Selinexor in combination with R-GDP for patients with relapsed/refractory B-cell lymphoma: final results of 18 patients treated at RP2D of selinexor in the Selinda phase Ib Lysa study. Abstract #2948. Presented at the 64th American Society of Hematology Annual Meeting, December 10-13, 2022; New Orleans, Louisiana.

Post Tags:Lymphoma ASH 22
Advertisement
Advertisement
Advertisement