Outcomes for patients with refractory, aggressive non-Hodgkin lymphoma (NHL) are poor with current therapies.

Axicabtagene ciloleucel (axi-cel) is an anti-CD19 chimeric antigen receptor (CAR) T cell therapy.

ZUMA-1 is the first multicenter trial of axi-cel in refractory, aggressive NHL.

In this phase 2 trial, 101 patients with diffuse large B cell lymphoma (DLBCL), primary mediastinal B cell lymphoma (PMBCL), or transformed follicular lymphoma (TFL) with refractory or relapsed disease, received axi-cel at a target dose of 2 x 106 cells/kg.

ZUMA-1 met the primary study endpoint with an objective response rate (ORR) of 82% (n = 92; P<.0001).

In the modified intent-to-treat population of all 101 patients who received axi-cel treatment, the ORR was 82% including a complete response (CR) rate of 54%.

These responses were consistent across key covariates including disease subtype, refractory status, stage, and International Prognostic Index score.

The CR rate observed in this trial was 7-fold higher compared with historical controls and after a median follow up time of 8.7 months, nearly half of the patients had an ongoing response.

Common grade ≥3 treatment-emergent adverse events were neutropenia (66%), leukopenia (44%), anemia (43%), febrile neutropenia (31%), and encephalopathy (21%).

Grade ≥3 cytokine release syndrome and neurologic events occurred in 13% and 28% of patients, respectively.

These results show that treatment with axi-cel significantly improves ORR with a manageable safety profile in patients with few other treatment options.

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Source: EHA