The phase 2 LOTIS-2 clinical trial supported the accelerated approval of loncastuximab tesirine for patients with relapsed or refractory large B-cell lymphoma.
An antibody-drug conjugate (ADC) for patients with relapsed or refractory DLBCL following 2 or more lines of prior therapy.
Loncastuximab tesirine is a CD19-directed ADC designed to bind irreversibly to DNA to create interstrand cross-links that block DNA strand separation, disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death.
Zynlonta tradename.
A therapy for patients with relapsed or refractory large B-cell lymphoma following 2 or more prior lines of therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
Loncastuximab tesirine demonstrated an objective response rate (ORR) of 48.3% and a complete response rate of 24.1%.
The median duration of response in 70 responders was 10.3 months, with a median time to response of 1.3 months
Most common grade 3 or higher treatment-emergent adverse events observed being neutropenia with a low incidence of febrile neutropenia, thrombocytopenia, gamma-glutamyl transferase increase, and anemia.