Tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion

Michael R. Bishop, Richard Maziarz, Edmund K. Waller, Ulrich Jäger, Jason R. Westin, Joseph P. McGuirk, Isabelle Fleury, Harald Holte, Peter Borchmann, Christopher Del Corral, Ranjan Tiwari, Özlem Anak, Rakesh Awasthi, Lida Pacaud, Vadim V. Romanov, Stephen J. Schuster

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4 Scopus citations

Abstract

Tisagenlecleucel demonstrated high rates of durable responses in adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) in the JULIET trial. Most patients (92%) received bridging therapies to control disease after study entry and before tisagenlecleucel infusion. Here, we examine the efficacy and safety of tisagenlecleucel in the subset of 7 patients who achieved complete response (CR) after bridging therapy and before tisagenlecleucel infusion. Tisagenlecleucel rapidly expanded in all 7 patients, and the transgene levels were measurable for up to 2 years after infusion. After infusion, all 7 patients were still in CR at the month 3 evaluation, and 5 of 7 patients remained progression-free .12 months. Adverse events were similar to the overall JULIET population. Cytokine release syndrome (CRS) was reported in 4 of 7 patients (grade 2 5 2 and grade 3 5 2 using the Penn grading scale), and 1 patient experienced grade 1 neurotoxicity. No patient required tocilizumab or steroids for CRS management. These data provide preliminary evidence of tisagenlecleucel efficacy in patients with r/r DLBCL without detectable disease after bridging or salvage therapies and warrant further investigation of tisagenlecleucel as consolidative therapy in future trials. This trial was registered at www.clinicaltrials.gov as #NCT02445248.

Original languageEnglish (US)
Pages (from-to)2230-2236
Number of pages7
JournalBlood Advances
Volume3
Issue number14
DOIs
StatePublished - Jul 23 2019

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ASJC Scopus subject areas

  • Medicine(all)

Cite this

Bishop, M. R., Maziarz, R., Waller, E. K., Jäger, U., Westin, J. R., McGuirk, J. P., Fleury, I., Holte, H., Borchmann, P., Del Corral, C., Tiwari, R., Anak, Ö., Awasthi, R., Pacaud, L., Romanov, V. V., & Schuster, S. J. (2019). Tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma patients without measurable disease at infusion. Blood Advances, 3(14), 2230-2236. https://doi.org/10.1182/bloodadvances.2019000151