Blood Advances (Jul 2019)

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

  • Michael R. Bishop,
  • Richard T. 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

Journal volume & issue
Vol. 3, no. 14
pp. 2230 – 2236

Abstract

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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 = 2 and grade 3 = 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.