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On September 13, 2021, the European Commission (EC) granted orphan drug designation to loncastuximab tesirine for the treatment of patients with diffuse large B-cell lymphoma (DLBCL).1 Loncastuximab tesirine is an antibody-drug conjugate (ADC) consisting of a CD19-directed monoclonal antibody coupled with a pyrrolobenzodiazepine (PBD) dimer cytotoxic alkylating agent. The monoclonal antibody component binds to CD19, which is expressed on the surface of B cells, and then releases the cytotoxic agent to induce apoptosis.2
This approval was based on results from the phase II, multicenter, single-arm LOTIS-2 trial. Updated results from LOTIS-2 were presented at the 9th Society of Hematologic Oncology (SOHO) Annual Meeting in an oral presentation by Brad S. Kahl.3 Patients enrolled in LOTIS-2 had pathologically defined relapsed or refractory (R/R) DLBCL following at least two prior systemic therapies. Updated safety and efficacy data (≥17 months since first dose of loncastuximab tesirine) demonstrated an overall response rate of 48.3% (70/145 patients), with 24.1% of patients having a complete response (CR). The median duration of response in this most recent update was 13.4 months for all responders, and was not yet reached in patients with a CR.3
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 at least two prior lines of therapy, which was previously reported on the Lymphoma Hub.
Phase II study of loncastuximab tesirine, a novel antibody–drug conjugate, in R/R DLBCL
Interview with Carmelo Carlo-Stella, Humanitas University, Milan, IT, during the 25th Congress of the EHA about the phase II study of loncastuximab tesirine in...
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...
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