Durable responses for loncastuximab tesirine in relapsed/refractory DLBCL

Loncastuximab tesirine displayed durable, long-term responses in patients with heavily pre-treated diffuse large B-cell lymphoma (DLBCL), the phase 2 LOTIS-2 trial showed. Moreover, no new safety issues were reported during the long-term follow-up.

“Patients with DLBCL who relapse after stem cell transplantation or CAR T-cell therapy, or who are refractory to second-line therapy have a poor prognosis,” said Dr Paolo Caimi (Cleveland Clinic, Ohio, USA). “There is an unmet need for accessible therapies with manageable toxicity profiles that have displayed long-term disease control in patients with relapsed or refractory DLBCL.” The phase 2 LOTIS-2 trial (n=145, NCT03589469) investigated the anti-tumour activity of the anti-CD19 monoclonal antibody-drug conjugate (conjugated drug: loncastuximab tesirine) in participants with relapsed/refractory DLBCL in [1] and Dr Caimi presented the long-term efficacy and safety results of this trial [2].

The overall response rate was 48.3% and the complete response rate was 24.8%. In the complete study population, the duration of response was 13.4 months, whereas the duration of response was ‘not reached’ in the subset of participants who had a complete response (n=36). The corresponding results for the median progression-free survival were 4.9 months and ‘not reached’. Also, the median overall survival was ‘not reached’ in the subset of participants who had a complete response and accumulated to 9.5 months in the overall study population.

According to the authors, no new safety signals emerged during the long-term follow-up. The most frequently reported grade ≥ 3 treatment-emergent adverse events were neutropenia (26%), thrombocytopenia (18%), increased gamma-glutamyl transferase (17%), and anaemia (10%).

Durable responses of loncastuximab tesirine were reported for participants with RR DLCBL during the long-term follow-up of the LOTIS-2 trial.

1. Caimi PF, et al. Lancet. 2021;22(6):790─800
2. Caimi PF, et al. Long-term responses with loncastuximab tesirine: updated results from LOTIS-2, the pivotal phase 2 study of patients with relapsed/refractory diffuse large B-cell lymphoma. P1132, EHA 2023 Annual Congress, 8─11 June, Frankfurt, Germany.

 

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Posted on 2 August, 202323 April, 2024