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. 2019 Aug 1;26(4):253–265. doi: 10.3747/co.26.5421

TABLE II.

Pivotal studies of chimeric antigen receptor T cell therapy in relapsed or refractory diffuse large B cell lymphoma

Treatment Reference (study name) Phase Patients

(n) Details
Axicabtagene ciloleucel Locke et al., 201956 and Neelapu et al., 201824 (ZUMA-1) I/II 108
  • ▪ Median 3 prior therapy lines

Efficacy in DLBCL
  • ▪ Median follow-up: 27.1 months

  • ▪ Median progression-free survival: 5.9 months; median overall survival: not reached; best overall response rate: 83%; best complete response: 58%; median duration of response: 11.1 months

Safety
  • ▪ Grade 3 or greater adverse events: cytokine release syndrome, 11%; neurotoxicity, 32%; neutropenia, 39%; anemia, 45%; thrombocytopenia, 24%

Jacobson et al., 201857 Real-world setting 76
  • ▪ 36 with DLBCL

  • ▪ Prior therapy lines not given

Efficacy in DLBCL▪ Median follow-up: 4 months; best overall response rate: 64%a; best complete response: 41%aSafety▪ Grade 3 or greater adverse events: cytokine release syndrome, 17%; neurotoxicity, 38%
Nastoupil et al., 201858 Real-world setting 211
  • ▪ 61% with DLBCL

  • ▪ Prior therapy lines not given

Efficacy in DLBCL
  • ▪ Median follow-up: not given

  • ▪ 1-Month overall response rate: 79%; 1-month complete response: 50%

Safety
  • ▪ Grade 3 or greater adverse events: cytokine release syndrome, 7%; neurotoxicity, 31%


Lisocabtagene maraleucel Abramson et al., 201825 (TRANSCEND) I 91
  • ▪ Median 3 prior therapy lines

Efficacy in DLBCL
  • ▪ Median follow-up: not given

  • ▪ Best overall response rate: 74%a; best complete response: 52%a

Safety
  • ▪ Grade 3 or greater adverse events: cytokine release syndrome, 1%; neurotoxicity, 12%


Tisagenlecleucel Schuster et al., 201959 (JULIET) II 93
  • ▪ More than 3 prior therapy lines in 21%

  • ▪ Median time from infusion to data cut-off: 14 months

Efficacy in DLBCL
  • ▪ Median progression-free survival: not reported; median overall survival: 12 months; best overall response rate: 52%a; best complete response: 40%a; median duration of response: not reached

Safety
  • ▪ Grade 3 or greater adverse events: cytokine release syndrome, 22%; neurotoxicity, 12%; cytopenias for more than 28 days: 32%; infections, 20%; febrile neutropenia, 14%

a

Recorded from study start to disease progression.

DLBCL = diffuse large B-cell lymphoma.