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. Author manuscript; available in PMC: 2022 Jun 28.
Published in final edited form as: Expert Rev Anticancer Ther. 2018 Oct;18(10):959–971. doi: 10.1080/14737140.2018.1512411

Table 2.

Summary of safety outcomes in clinical trials for tisagenlecleucel and other drugs labeled for the same indication.

Treatment related
devent
 CRS/Immune event
 Neurologic event
 Other common events
Drug Any grade Grade 3–5 Any grade Grade 3–5 Any grade Grade 3–5 Any grade Grade 3–5 References
– * – 30 (100%) 8 (27%) 13 (43%) – – – [46]
  Tisagenlecleucel – – 52 (88%) 16 (27%) – – – – [45]
71 (95%) 55 (73%) 58 (77%) 35 (47%) 30 (40%) 10 (13%)

  • Infection: 32 (43%)

  • Febrile neutropenia: 26 (35%)

  • Cytopenias: 28 (37%)

  • Tumor lysis: 3 (4%)

  • Infection: 18 (24%)

  • Febrile neutropenia: 26 (35%)

  • Cytopenias: 24 (32%)

  • Tumor lysis: 3 (4%)

  • Acute kidney injury 6 (8%)

 [35]
Other CD19-directed CART cells
  MSKCC – – – 9 (56%) – 1 (6%) –

  • Febrile neutropenia: 11 (69%)

  • Hypotension: 6 (38%)

  • Electrolyte disturbance: 4 (25%)

 [62]
  FHCRC – – 25 (83%) 7 (23%) 15 (50%) 15 (50%) – – [56]
  NCI – – – 7 (13%) 5 (9%) 3 (6%) – – [82]
188 (99%) 155 (82%) 3 (2%) 0 98 (52%) 24 (13%)

  • Pyrexia: 113 (60%)

  • Febrile neutropenia: 113 (60%)

  • Hypokalemia: 45 (24%)

  • Anemia: 38 (20%)

  • Neutropenia: 33 (17%)

  • Febrile neutropenia: 48 (25%)

  • Neutropenia: 30 (16%)

  • Anemia: 27 (14%)

  • Thrombocytopenia: 16 (8%)

 [29]
  Blinatumomab 263 (99%) 231 (87%) – 13 (5%) – 25 (9%) –

  • Neutropenia: 101 (37.8%)

  • Infection: 91 (34%)

  • Transaminitis: 24 (13%)

 [30]
  Inotuzumab 67 (48%) 64 (46%) – – – –

  • Febrile neutropenia: 16 (12%)

  • Veno-occlusive disease: 16 (11%)

  • Pneumonia 5 (4%)

  • Febrile neutropenia: 16 (12%)

  • Veno-occlusive disease: 13 (19%)

  • Pneumonia 5 (4%)

 [33]
  Clofarabine – – – – – 8 (13%) –

  • Febrile neutropenia: 30 (49%)

  • Anorexia: 12 (20%)

  • Hypotension: 11 (18%)

  • Nausea: 10 (16%)

  • Pyrexia: 9 (15%)

  • Neutropenia:9 (15%)

 [19]
  Vincristine 53 (82%) 37 (57%) – – 41 (63%) 13 (20%)

  • GI disorders: 33 (51%)

  • Blood/lymphatic system disorders: 19 (29%)

  • General disorders/administration site concerns: 16 (25%)

  • GI disorders: 8 (12%)

  • Blood/lymphatic system disorders: 14 (22%)

  • General disorders/administration site concerns: 5 (8%)

 [16]

CRS, cytokine release syndrome; CAR, chimeric antigen receptor; MSKCC, Memorial Sloan Kettering Cancer Center; FHCRC, Fred Hutchinson Cancer Research Center; NCI, National Cancer Institute; GI, gastrointestinal.

*

Data on adverse event not specifically included in publication.