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Axicabtagene Ciloleucel Shows High CR Rates in Primary Analysis of ZUMA-1 Study

Silas Inman @silasinman
Published: Tuesday, Feb 28, 2017

Dr Frederick L. Locke

Frederick L. Locke, MD

Treatment with axicabtagene ciloleucel (KTE-C19) demonstrated an objective response rate (ORR) of 82% and a complete response (CR) rate of 54% for patients with aggressive non-Hodgkin lymphoma, according to the primary analysis of the ZUMA-1 trial announced by Kite Pharma, the company developing the CAR T-cell therapy.

The most common grade ≥3 adverse events (AEs) were anemia (43%), neutropenia (39%), decreased neutrophil count (32%), febrile neutropenia (31%), decreased white blood cell count (29%), thrombocytopenia (24%), encephalopathy (21%), and decreased lymphocyte count (20%). There were 3 fatal events in the study, 2 of which were deemed related to axicabtagene ciloleucel: hemophagocytic lymphohistiocytosis and cardiac arrest in the setting of cytokine release syndrome (CRS). The third death was from pulmonary embolism.

Data from 93 patients were available for the interim analysis from the ZUMA-1 trial, whereas the primary assessment contained data for 101 patients. With more patients assessed, the rate of CRS declined from 18% at the interim assessment to 13% for the primary analysis. Additionally, neurologic events dropped from 34% in the interim analysis to 28% in the primary assessment. There continued to be no cases of cerebral edema.

"These results with axicabtagene ciloleucel are exceptional and suggest that more than a third of patients with refractory aggressive NHL could potentially be cured after a single infusion of axicabtagene ciloleucel," said Jeff Wiezorek, MD, senior vice president of Clinical Development at Kite Pharma, said in as statement.

Kite Pharma initiated a rolling submission of data to the FDA for a biologics license application in December 2016, which is permitted as part of a breakthrough therapy designation received by axicabtagene ciloleucel in December 2015. The company is seeking approval for patients with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma who are ineligible for autologous stem cell transplant. Kite expects to complete this submission before the end of March.

Full data from the primary analysis of the ZUMA-1 trial will be presented at the 2017 AACR Annual Meeting.

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