Efficacy

Xpovio (Selinexor) Efficacy in Treating Lymphoma

Xpovio (selinexor) is an oral selective inhibitor of nuclear export (SINE) compound that has shown efficacy in the treatment of certain types of lymphoma, particularly diffuse large B-cell lymphoma (DLBCL). It functions by inhibiting the nuclear export protein XPO1, which leads to the accumulation of tumor suppressor proteins in the cell nucleus, inducing cancer cell death. Xpovio received accelerated approval by the U.S. Food and Drug Administration (FDA) for use in adult patients with relapsed or refractory DLBCL, not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This approval was based on the response rate observed in a multicenter, single-arm trial.

The efficacy of Xpovio in lymphoma patients was evaluated through its objective response rate (ORR), which is the proportion of patients with a partial or complete response to the medicine. In clinical trials, Xpovio demonstrated an ORR of 28% in heavily pretreated patients with relapsed or refractory DLBCL. The median duration of response (DOR) for these patients was observed to be 23.0 weeks, indicating a temporary but meaningful response in a subset of patients with limited treatment options.

Zynlonta (Loncastuximab Tesirine-lpyl) Efficacy in Treating Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate used in the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy. This includes DLBCL, high-grade B-cell lymphoma, and DLBCL arising from low-grade lymphoma. Zynlonta works by specifically targeting CD19, a protein expressed on the surface of B-cells, and upon binding, it releases a cytotoxic agent that damages the DNA of the targeted cells, leading to cell death.

The FDA granted accelerated approval to Zynlonta based on the results from a multicenter, open-label, single-arm trial. The trial demonstrated an ORR of 48.3% with a complete response rate of 24.1% in patients treated with Zynlonta. The median DOR for patients who achieved a response was 10.3 months, showcasing the potential of Zynlonta to provide a durable response in a patient population with a high unmet need.