Long-term safety of liso-cel in large B-cell lymphoma

In this video, Prof Dr Stephan Mielke presents a pooled longitudinal safety analysis of lisocabtagene maraleucel (liso-cel) in 420 patients with relapsed or refractory large B-cell lymphoma treated in the second-line or later setting. The analysis combined data from the TRANSFORM, PILOT and TRANSCEND NHL 001 studies and focused on the evolution of haematological toxicities, infections, B-cell aplasia, hypogammaglobulinaemia and second primary malignancies over time. 

Grade ≥3 cytopenias were most frequent early after infusion and declined substantially during follow-up, with limited need for growth factor support or transfusions beyond the first three months. Infections showed a similar pattern: severe infections were uncommon and occurred predominantly during the first three months, highlighting the importance of close monitoring during early follow-up. B-cell aplasia and hypogammaglobulinaemia were more persistent, although recovery occurred gradually in a proportion of patients. Second primary malignancies were infrequent and were mainly non-melanoma skin cancers or haematological malignancies; no clear additional safety signal specifically attributable to liso-cel was identified.

Overall, the findings support a favourable and manageable long-term safety profile for liso-cel. Prof Dr Mielke notes that the concentration of clinically relevant toxicities in the first months after treatment may facilitate outpatient administration or early discharge, provided that centres have appropriate systems for rapid recognition and management of infections and other complications.