ZUMA-2: A phase 2 multi-center study evaluating the efficacy of KTE-C19 (Anti-CD19 CAR T cells) in patients with relapsed/refractory Mantle cell lymphoma (R/R MCL)

Wang, M.; Locke, Frederick L.; Siddiqi, Tanya; Castro, Januario E.; Shah, Bijal; Lee, H.; Budde, Lihua E.; Choi, Michael Y.; Anasetti, Claudio; Champlin, Richard E.; Forman, Stephen J.; Kipps, Thomas J.; Bot, Adrian; Rossi, John M.; Navale, Lynn; Jiang, Yihua; Aycock, Jeff; Elias, Meg; Wiezorek, Jeff; Go, William Y.

doi:10.1093/annonc/mdw375.40

Cited by 8 publications

(6 citation statements)

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“…Ibrutinib—CART-cell interaction is complex and remains a controversial issue. We are looking forward to the results of ZUMA-2 study (NCT02601313) [24].…”

Section: Confounding Factorsmentioning

confidence: 99%

Mechanisms of failure of chimeric antigen receptor T-cell therapy

Chen

2019

Current Opinion in Hematology

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“…Ibrutinib—CART-cell interaction is complex and remains a controversial issue. We are looking forward to the results of ZUMA-2 study (NCT02601313) [24].…”

Section: Confounding Factorsmentioning

confidence: 99%

Mechanisms of failure of chimeric antigen receptor T-cell therapy

Chen

2019

Current Opinion in Hematology

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“…Current axi-cel trials are also evaluating safety and efficacy in other CD19-positive malignancies and patient populations, including pediatric ALL, pediatric NHL, mantle cell lymphoma, and CLL (ZUMA-2, NCT02601313; ZUMA-3, NCT02614066; ZUMA-4, NCT02625480; ZUMA-8, NCT03624036). 62-64…”

Section: Future Directionsmentioning

confidence: 99%

Axicabtagene Ciloleucel: Clinical Data for the Use of CAR T-cell Therapy in Relapsed and Refractory Large B-cell Lymphoma

2020

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Objective: To evaluate the literature for axicabtagene ciloleucel (axi-cel), a first-in-class chimeric antigen receptor (CAR) T-cell therapy, in the treatment of relapsed/refractory (r/r) large B-cell lymphoma (LBCL). Data Sources: We conducted a PubMed (inception to June 22, 2020) and ClinicalTrials.gov search using the following terms: CD19, chimeric antigen receptor, and lymphoma. Study Selection and Data Extraction: All retrospective and prospective studies evaluating the use of axi-cel in LBCL were reviewed. Data Synthesis: In the pivotal ZUMA-1 trial, axi-cel exhibited unprecedented overall and complete response rates of 83% and 58%, respectively. With a median follow-up of 27.1 months, 39% of patients had ongoing responses. Furthermore, postmarketing retrospective analyses found similar response rates in a more clinically diverse LBCL patient population. Novel CAR T-cell therapy elicits unique and potentially life-threatening toxicities that include cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Studies reported grade ≥3 CRS in 7% to 14% of patients and grade ≥3 ICANS in 31% to 55% of patients. Relevance to Patient Care and Clinical Practice: Axi-cel was the first US Food and Drug Administration–approved genetically engineered autologous CAR T-cell agent in r/r LBCL, representing an important milestone and paradigm shift in cancer treatment. Adoptive T-cell immunotherapy is a breakthrough treatment modality requiring careful patient selection, multidisciplinary collaboration, comprehensive patient counseling, and expert training to ensure optimal treatment. Conclusions: The initial and ongoing results with axi-cel are encouraging, but long-term safety and efficacy data are lacking. Additional studies are required to identify axi-cel’s ideal place in LBCL therapy.

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“…Across all patients, 13 and 28% of patients experienced grade !3 CRS or NE, respectively. The same anti-CD19 CAR construct is being evaluated in three other studies of standalone CAR T cell therapy following conditioning chemotherapy for the treatment of mantle cell lymphoma and adult and pediatric acute lymphoblastic leukemia (NCT02601313, NCT02614066, and NCT02625480, respectively) [42][43][44]. Additionally, axicabtagene ciloleucel is currently being investigated in a study of patients with refractory DLBCL evaluating conditioning chemotherapy and CAR T cells followed by a limited course of PD-L1 blockade with atezolizumab (NCT02926833).…”

Section: Initial Clinical Experience With Car T Cells In B Cell Maligmentioning

confidence: 99%