AACR 2017 | Primary results from the pivotal ZUMA-1 trial of KTE-C19 in refractory aggressive Non-Hodgkin Lymphoma patients

On Sunday 2^nd April, during the “CTSY02 - Immuno-oncology Biomarkers in Clinical Trials” session at AACR 2017, Frederick L. Locke, MD, of the H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, gave a talk titled “Primary results from ZUMA-1: a pivotal trial of axicabtagene ciloleucel (axicel; KTE-C19) in patients with refractory aggressive non-Hodgkin lymphoma (NHL).”

Dr. Locke began his talk by explaining that there is a significant unmet need in refractory aggressive Non-Hodgkin Lymphoma (NHL). It is the most common cancer of the blood in the United States and outcomes for refractory aggressive disease is poor: in the SCHOLAR-1 meta-analysis ORR was 26% (CR = 8%; PR = 18%) and median OS was 6.6 months.

Axicabtagene ciloleucel (axicel; KTE-C19) is an autologous, Chimeric Antigen Receptor (T-cell) therapy specific against CD19+ cells and functions via CD3ζ/CD28-based signaling.

Dr. Locke then discussed the design of the ZUMA-1 trial:

The talk then focused on the preliminary results of the trial, which met its primary endpoint of ORR (P < 0.0001) in the combined group. In addition to this, 44% of responses are ongoing after a median follow-up of 8.7 months.

Dr. Locke went on to state that 6-month PFS rates were consistent across key covariates. A median PFS of 5.9 months (95% CI, 3.4–9.8) was reported and median OS is not reached at the median follow-up of 8.7 months (95% CI, 10.5–NR). Compared with the SCHOLAR-1 data, 6-month OS rate is higher in the ZUMA-1 trial: 55% versus 80%, respectively.

An overview of adverse events experienced during the trial was presented:

Dr. Locke concluded the talk with a succinct summary slide, emphasizing that ZUMA-1 is the first pivotal trial of CD19-specific CAR T-cell therapy in patients with refractory aggressive NHL.