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FDA Approves Loncastuximab Tesirine-lpyl for Patients With DLBCL

On April 23, 2021, the FDA approved loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), a CD19-directed antibody and alkylating agent conjugate, for the treatment of patients with released or refractory large B-cell lymphoma after 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.

The efficacy of loncastuximab tesirine-lpyl was evaluated in LOTIS-2, an open-label, single-arm trial which enrolled 145 patients with relapsed or refractory DLBCL or high-grade B-cell lymphoma after at least 2 years of prior therapy.

Patients in the study were given loncastuximab tesirine-lpyl 0.15mg/kg every 3 weeks for 2 cycles, then 0.075mg/kg every 3 weeks for subsequent cycles until progressive disease or unacceptable toxicity.

The overall response rate (ORR) assessed by an independent review committee using Lugano 2014 criteria was the main efficacy end point.

The confirmed ORR was 48.3% (95% CI, 39.9-56.7) and the complete response rate was 24.1% (95% CI, 17.4-31.9). After a median follow-up of 7.3 months, the median duration of response (DOR) was 10.3 months (95% CI, 6.9-NE). Of 70 patients who achieved objective responses, 36% were censored for response duration prior to 3 months.

The most common (≥20%) adverse events associated with loncastuximab tesirine-lpyl include thrombocytopenia, increased gamma- glutamyltransferase, neutropenia, anemia, hyperglycemia, transaminase elevation, fatigue, hypoalbuminemia, rash, edema, nausea, and musculoskeletal pain.

Source: US Food and Drug Administration. FDA grants accelerated approval to loncastuximab tesirine-lpyl for large B-cell lymphoma. April 23, 2021. www.fda.gov/drugs/fda-grants-accelerated-approval-loncastuximab-tesirine-lpyl-large-b-cell-lymphoma. Accessed April 26, 2021.—Emily Bader

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