The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for loncastuximab tesirine (ADC Therapeutics) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

Loncastuximab tesirine (Lonca, formerly known as ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Upon binding to a CD19-expressing cell, Lonca is internalized in the cell where enzymes release the cytotoxic PBD-based dimer, which binds to DNA to create interstrand cross-links. These cross-links are designed to disrupt DNA metabolic processes such as replication, which ultimately leads to cell death.

The BLA is supported by data from an open-label, single-arm phase 2 trial (LOTIS 2) that evaluated the efficacy and safety of Lonca in 145 adults with relapsed or refractory DLBCL following 2 or more lines of prior therapy; the primary end point was overall response rate.

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Results of the study showed an overall response rate of 48.3% (n=70) and a complete response rate of 24.1% (n=35). As for safety, the most common grade 3 or greater treatment-emergent adverse events that occurred in at least 10% of patients were neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), increased gamma-glutamyl transferase (16.6%), and anemia (10.3%).

Additional data from subgroup analyses of LOTIS 2 will be presented at the upcoming 62nd American Society for Hematology (ASH) Annual Meeting on December 5, 2020.

A Prescription Drug User Fee Act (PDUFA) target date of May 21, 2021 has been set for this application.

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ADC Therapeutics announces FDA accepts Biologics License Application and grants Priority Review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma. [press release]. Lausanne, Switzerland: ADC Therapeutics; November 20, 2020. 

This article originally appeared on MPR