Loncastuximab tesirine receives positive CHMP opinion for the treatment of patients with R/R DLBCL

On September 16, 2022, it was announced that loncastuximab tesirine received a positive opinion in Europe from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).¹

The approval was based on the supporting results from the phase II LOTIS-2 trial (NCT03589469).¹

Loncastuximab tesirine is a CD19-targeted antibody and alkylating agent conjugate designed to target and destroy CD19-expressing malignant B cells.¹

LOTIS-2 is a single-arm, multicenter trial in 145 adult patients with R/R DLBCL who received ≥2 prior lines of systemic therapy. The study included heavily pretreated patients with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple-hit genetics, and patients who had a stem cell transplant and chimeric antigen receptor (CAR) T-cell therapy prior to their treatment.² The study showed that loncastuximab tesirine produces positive responses (an overall response rate of 48.3% and a complete response rate of 24.1%) in heavily pretreated patients with R/R DLBCL. The median duration of response was 10.3 months. The most common Grade ≥3 treatment-emergent adverse events reported in ≥10% of patients were neutropenia (26.2%), thrombocytopenia (17.9%), increased gamma-glutamyltransferase (17.2%), and anemia (10.3%).²

This positive CHMP opinion is now referred to the European Commission for approval—a decision is expected later this year.¹

Prior to this, on April 23, 2021, the U.S. Food and Drug Administration (FDA) issued an accelerated approval for loncastuximab tesirine for the treatment of adult patients with R/R DLBCL who have had ≥2 prior lines of therapy.²