What is the efficacy of chimeric antigen receptor (CAR) T-cell therapy for mantle cell lymphoma?

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

Answer

The FDA granted accelerated approval to KTE-X19 (Tecartus) in July 2020 for patients with R/R mantle cell lymphoma after failure of therapy with a BTK inhibitor. Approval was based on the Zuma-2 trial, which showed an impressive 93% ORR (95% confidence interval [CI], 84-98%) and 67% CR (95% CI, 53-78%) in the primary efficacy analysis of 60 patients. After a median follow up of 12.3 months, 57% of those patients were still in remission. Subgroup analysis showed that KTE-X19 was effective in patients with high-risk mantle cell lymphoma (eg, TP53 mutation, blastoid morphologic features, Ki-67 proliferation index of 50% or higher). [22]


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