What is the role of tisagenlecleucel (Kymriah) in chimeric antigen receptor (CAR) T-cell therapy?

Updated: Dec 17, 2020
  • Author: Sameh Gaballa, MD, MS; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Answer

After its approval for ALL, in May 2018 tisagenlecleucel gained approval for adults with R/R DLBCL, including DLBCL not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma, after 2 or more lines of systemic therapy. [18]

Approval was based on the single-arm, open-label, multicenter, phase II JULIET trial in adults with R/R DLBCL and DLBCL after transformation from follicular lymphoma. Eligible patients must have received at least 2 prior lines of therapy, including an anthracycline and rituximab, or relapsed following ASCT. Patients received a single infusion of tisagenlecleucel following completion of lymphodepleting chemotherapy. [19]

The ORR for the 99 evaluable patients was 54% (95% CI:43%-64%) with a CR rate of 40%. Responses were consistent across all subgroups, including prior autologous stem cell transplantation and double/triple hit lymphoma. With a median follow-up time of 19.3 months, the median duration of response (DOR) was not reached. [20]


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