Brian T. Hill, MD, PhD, discusses the data from the SADAL trial that led to the FDA approval of selinexor for use in patients with diffuse large B-cell lymphoma.
Brian T. Hill, MD, PhD, director of the Lymphoid Malignancies Program and staff physician at Taussig Cancer Institute, as well as an assistant professor of Hematology and Oncology withCleveland Clinic, discusses the data from the SADAL trial that led to the FDA approval of selinexor (Xpovio) for use in patients with diffuse large B-cell lymphoma (DLBCL).
Selinexor was previously FDA-approved for use in patients with heavily pretreated multiple myeloma and has recently been indicated for patients with relapsed/refractory DLBCL based on findings from the phase 2b SADAL trial, says Hill.
SADAL enrolled a heavily pretreated patient population, many of whom had received multiple lines of previous therapy, including autologous stem cell transplant.
In these patients, selinexor was administered orally twice weekly at 1 of 2 doses: 100 mg or 60 mg. The toxicity seen at the high dose was significant in terms of cytopenia and gastrointestinal adverse effects (AEs). However, those AEs were reduced when selinexor was given at the dose of 60 mg twice a week.
The overall response rate was 32% in those who received the lower dose, which is very reasonable for a heavily pretreated patient population, concludes Hill.