R/R mantle cell lymphoma: novel CAR T-cell yields high response rate in phase 2

  • Wang M & al.
  • N Engl J Med
  • 2 Apr 2020

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • A single infusion of KTE-X19, a novel chimeric antigen receptor (CAR) T-cell therapy, yields durable response in patients with relapsed or refractory mantle cell lymphoma after failure of Bruton's tyrosine kinase inhibitor therapy.
  • The treatment is associated with a higher rate of serious toxicities.

Why this matters

  • Patients with recurrent/relapsed disease have poor prognosis and warrant novel therapeutic options.

Study design

  • Multicenter phase 2 ZUMA-2 trial evaluated 74 patients with relapsed or refractory mantle cell lymphoma who received KTE-X19.
  • Funding: Kite, a Gilead company.

Key results

  • Primary efficacy analysis of 60 patients treated and followed up for 7 months.
    • The objective response rate was 93% (complete response, 67%).
  • The median follow-up was 12.3 months.
  • Overall population:
    • 75% of patients achieved objective response and 59% had complete response.
    • At data cutoff, 57% of patients with complete response were in remission.
  • At 12 months:
    • PFS was 61%.
    • OS was 83%.
  • The grade ≥3 adverse event rate was 99%.
    • Most common were cytopenias (94%) and infections (32%).
    • Nonfatal cytokine release syndrome and neurologic events occurred in 15% and 31% of patients.
  • 68% of patients experienced serious toxicities.

Limitations

  • Single-group study.