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Loncastuximab tesirine in relapsed or refractory diffuse large B-cell lymphoma (LOTIS-2): A multicentre, open-label, single-arm, phase 2 trial

The Lancet Oncology May 16, 2021

Caimi PF, Ai W, Alderuccio JP, et al. - Researchers conducted this multicentre, open-label, single-arm, phase 2 trial (LOTIS-2) to assess loncastuximab tesirine’s (a CD19-directed antibody–drug conjugate) antitumour activity and safety in patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Eligible candidates were administered loncastuximab tesirine intravenously on day 1 of each 21-day cycle, at 150 μg/kg for two cycles, then 75 μg/kg thereafter, for up to 1 year or until disease relapse or advancement, unacceptable toxicity, death, major protocol deviation, pregnancy, or patient, investigator, or sponsor decision. Complete or partial response was achieved in 70 of 145 patients (overall response rate 48·3%); 35 showed complete response and 35 exhibited partial response. Findings showed substantial single-agent antitumour activity of loncastuximab tesirine as well as durable responses conferred by it along with an acceptable safety profile. Thus, loncastuximab tesirine potentially affords a new treatment choice for heavily pretreated cases with relapsed or refractory DLBCL.

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