What is the role of tisagenlecleucel (Kymriah) in the treatment of non-Hodgkin lymphoma/B-cell lymphoma?

Updated: Feb 23, 2021
  • Author: Mohammad Muhsin Chisti, MD, FACP; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

Tisagenlecleucel (Kymriah) is approved for treatment of R/R DLBCL in adult patients who have received 2 or more lines of systemic therapy. Indications include DLBCL not otherwise specified, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Approval was based on the single-arm, open-label, multicenter, phase 2 JULIET trial in adults with R/R DLBCL and DLBCL after transformation from follicular lymphoma. Eligible patients must have been treated with at least 2 prior lines of therapy, including an anthracycline and rituximab, or relapsed following stem cell transplantation. [20]

Study patients received a single infusion of tisagenlecleucel following completion of lymphodepleting chemotherapy. The overall response rate for the 68 evaluable patients was 50% (95% CI: 37.6, 62.4) with a complete response (CR) rate of 32% (95% CI: 21.5, 44.8). With a median follow-up time of 9.4 months, the duration of response (DOR) was longer in patients with a best overall response of CR, as compared with a best overall response of partial response (PR). In patients who achieved CR, the estimated median DOR was not reached (95% CI: 10.0 months, not estimable [NE]). The estimated median response duration in patients in PR was 3.4 months (95% CI: 1.0, NE). Common adverse reactions included cytokine release syndrome, hypogammaglobulinemia, infections, and encephalopathy. [21]


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