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Neelapu, Sattva S.; Jacobson, Caron A.; Ghobadi, Armin; Miklos, David B; Lekakis, Lazaros J.; Oluwole, Olalekan O.; Lin, Yi; Braunschweig, Ira; Hill, Brian T.; Timmerman, John M.; Deol, Abhinav; Reagan, Patrick M; Stiff, Patrick Joseph; Flinn, Ian W.; Farooq, Umar; Goy, Andre; McSweeney, Peter; Munoz, Javier; Siddiqi, Tanya; Chavez, Julio C.; Herrera, Alex F.; Bartlett, Nancy L.; Bot, Adrian A.; Shen, Rhine R.; [...]

5-Year Follow-Up Supports Curative Potential of Axicabtagene Ciloleucel in Refractory Large B-Cell Lymphoma (ZUMA-1)

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  • Media type: E-Article
  • Title: 5-Year Follow-Up Supports Curative Potential of Axicabtagene Ciloleucel in Refractory Large B-Cell Lymphoma (ZUMA-1)
  • Contributor: Neelapu, Sattva S.; Jacobson, Caron A.; Ghobadi, Armin; Miklos, David B; Lekakis, Lazaros J.; Oluwole, Olalekan O.; Lin, Yi; Braunschweig, Ira; Hill, Brian T.; Timmerman, John M.; Deol, Abhinav; Reagan, Patrick M; Stiff, Patrick Joseph; Flinn, Ian W.; Farooq, Umar; Goy, Andre; McSweeney, Peter; Munoz, Javier; Siddiqi, Tanya; Chavez, Julio C.; Herrera, Alex F.; Bartlett, Nancy L.; Bot, Adrian A.; Shen, Rhine R.; [...]
  • imprint: American Society of Hematology, 2023
  • Published in: Blood
  • Language: English
  • DOI: 10.1182/blood.2022018893
  • ISSN: 0006-4971; 1528-0020
  • Origination:
  • Footnote:
  • Description: <jats:p>In phase 2 of ZUMA-1, a single-arm, multicenter, registrational trial, axicabtagene ciloleucel (axi-cel) autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy demonstrated durable responses at 2 years in patients with refractory large B-cell lymphoma (LBCL). Here, we aimed to assess survival and safety in ZUMA-1 after 5 years of follow-up. Eligible adults with refractory LBCL (diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and transformed follicular lymphoma) received lymphodepleting chemotherapy followed by axi-cel infusion targeted at 2×106 cells/kg. Investigator-assessed response, updated survival, safety, and pharmacokinetic outcomes were assessed in treated patients. The objective response rate in the 101 treated patients was 83% (58% complete response rate), and with a median follow-up of 63.1 months, responses were ongoing at data cutoff in 31%. Median overall survival (OS) was 25.8 months and the estimated 5-year OS rate was 42.6%. Disease-specific survival (excluding deaths unrelated to disease progression) estimated at 5 years was 51.0%. No new serious adverse events or deaths related to axi-cel were observed after additional follow-up. Peripheral blood B cells were detectable in all evaluable patients at 3 years with polyclonal B-cell recovery in 91%. Ongoing responses at 60 months were associated with early CAR T-cell expansion. In conclusion, this 5-year follow-up analysis of ZUMA-1 demonstrates sustained overall and disease-specific survival, with no new safety signals in patients with refractory LBCL. Protracted B-cell aplasia was not required for durable responses. These findings support the curative potential of axi-cel in a subset of patients with aggressive B-cell lymphomas. ClinicalTrials.gov, number NCT02348216</jats:p>
  • Access State: Open Access