FDA Approval Insights: Selinexor in Relapsed/Refractory DLBCL

Welcome to Onclive On Air ^™! I’m your host today, Caroline Seymour.

Onclive On Air ^™ is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

Today, we had the pleasure of speaking with Brian T. Hill, MD, PhD, an assistant professor of Hematology and Oncology at the Cleveland Clinic, to discuss the FDA approval of selinexor (Xpovio) in diffuse large B-cell lymphoma (DLBCL).

On June 22, 2020, the FDA approved selinexor for the treatment of adult patients with relapsed/refractory DLBCL, not otherwise specified, who have received at least 2 prior therapies.

The approval is based on results from the phase 2b SADAL trial, in which selinexor led to an objective response rate (ORR) of 29%, including a 13% complete response rate.

Deep and durable responses were also reported, irrespective of DLBCL subtype. Among the 59 patients with germinal center B-cell (GCB) histology, the ORR was 33.9%, and in the 63 patients with the non-GCB subtype, the ORR was 20.6%. Across the overall population, the median overall survival (OS) was 9 months. The median OS had not yet been reached among responders.

Notably, selinexor is an oral agent that can be more easily administered compared with intravenous therapy or CAR T-cell therapy, which can be cumbersome to patients, says Hill. The approval of selinexor is a welcome addition, and one that will benefit patients who have exhausted all other options.

In our exclusive interview, Hill provided additional perspective on the FDA approval of selinexor in DLBCL.