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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
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
Loncastuximab tesirine in relapsed or refractory DLBCL: Results from a phase II trial
The CD19-targeted antibody–drug conjugate, loncastuximab tesirine, was recently added to the National Comprehensive Cancer Network (NCCN) Clinical Practice...
Loncastuximab tesirine granted priority review status by the FDA
On November 20, 2020, the U.S. Food and Drug Administration (FDA) accepted the biologics license application (BLA) for loncastuximab tesirine for the treatment of patients with relapsed...
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