IBCL-124: Interim Analysis of ZUMA-5: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (R/R iNHL)

Here, we report interim results from ZUMA-5, a Phase 2 study of axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in patients with relapsed/refractory iNHL. Adults with relapsed/refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) after ≥2 lines of thera...

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Published in:Clinical lymphoma, myeloma and leukemia Vol. 20; p. S278
Main Authors: Jacobson, Caron A., Chavez, Julio C., Sehgal, Alison R., William, Basem M., Munoz, Javier, Salles, Gilles, Casulo, Carla, Munshi, Pashna N., Maloney, David G., Vos, Sven de, Reshef, Ran, Leslie, Lori A., Yakoub-Agha, Ibrahim, Oluwole, Olalekan O., Fung, Henry C., Plaks, Vicki, Yang, Yin, Lee, Jennifer, Avanzi, Mauro P., Neelapu, Sattva S.
Format: Journal Article
Language:English
Published: Elsevier Inc 01.09.2020
Subjects:
CAR T cell therapy
chimeric antigen receptor
IBCL
indolent B-cell lymphoma
IBCL
chimeric antigen receptor
CAR T cell therapy
indolent B-cell lymphoma
ISSN:2152-2650, 2152-2669
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Summary:Here, we report interim results from ZUMA-5, a Phase 2 study of axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T cell therapy, in patients with relapsed/refractory iNHL. Adults with relapsed/refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL) after ≥2 lines of therapy (including an anti-CD20 monoclonal antibody with an alkylating agent) were eligible. Patients were leukapheresed and received conditioning chemotherapy followed by axi-cel at 2 × 106 CAR T cells/kg. The primary endpoint was objective response rate (ORR) by central review (Cheson, et al. J Clin Oncol. 2014). Secondary endpoints included duration of response (DOR), progression-free survival (PFS), overall survival (OS), safety, and blood levels of CAR T cells. As of 8/20/19, 94 patients (80 FL; 14 MZL) received axi-cel (median follow-up, 11.5 months). Median age was 63 years, 51% of patients had ≥3 FLIPI, 59% had high tumor bulk, 66% progressed < 2 years after first chemoimmunotherapy (POD24), and 73% were refractory to the last treatment. Of 87 patients evaluable for efficacy, ORR was 94% (79% complete response [CR] rate). Patients with FL (n=80) had an ORR of 95% (80% CR rate). Patients with MZL (n=7) had an ORR of 86% (71% CR rate). Overall, 68% of patients had ongoing responses as of the data cutoff. Updated data will be presented. Of 94 patients evaluable for safety, 83% experienced Grade ≥ 3 adverse events, most commonly neutropenia (33%) and anemia (28%). Grade ≥ 3 cytokine release syndrome (CRS) and neurologic events (NEs) occurred in 11% and 19% of patients, respectively. Median times to onset of CRS and NEs were 4 and 7 days; median durations were 6 and 14.5 days. There were 2 Grade 5 adverse events: multisystem organ failure in the context of CRS (related to axi-cel) and aortic dissection (unrelated to axi-cel). Median peak and AUC0-28 CAR T cell levels were 44 cells/μL and 490 cells/μL × day, respectively. Axi-cel showed significant clinical benefit, with high response rates, and a manageable safety profile in patients with relapsed/refractory iNHL. Funding provided by Kite, a Gilead Company.
ISSN:2152-2650
2152-2669
DOI:10.1016/S2152-2650(20)30898-3