Dr. Neelapu on the Safety Profile of KTE-C19 in Patients With Lymphoma

Sattva S. Neelapu, MD
Published: Thursday, Jan 12, 2017



Sattva S. Neelapu, MD, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the safety profile of KTE-C19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy explored in the ZUMA-1 trial for patients with aggressive lymphomas.

There were 2 common adverse events observed by researchers in the ZUMA-1 study, explains Neelapu. These include cytokine release syndrome (CRS) and neurological side effects. CRS typically manifests as body aches, fever, hypoxia, and a drop in blood pressure. The majority of CRS events were grades 1/2; 13% experienced grade 3/4 CRS, he adds.

Neurological events were of grade 1/2, including tremors, confusion, delirium, etc. Twenty-nine percent of patients had grade 3 or higher levels of neurological events. There were 2 treatment-related deaths that occurred on the study; 1 was from hemophagocytic lymphohistiocytosis, while the other was due to cardiac arrest in the setting of CRS. There was a third patient death caused by pulmonary embolism, but this was not related to KTE-C19, he says.


Sattva S. Neelapu, MD, associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, discusses the safety profile of KTE-C19, an anti-CD19 chimeric antigen receptor (CAR) T-cell therapy explored in the ZUMA-1 trial for patients with aggressive lymphomas.

There were 2 common adverse events observed by researchers in the ZUMA-1 study, explains Neelapu. These include cytokine release syndrome (CRS) and neurological side effects. CRS typically manifests as body aches, fever, hypoxia, and a drop in blood pressure. The majority of CRS events were grades 1/2; 13% experienced grade 3/4 CRS, he adds.

Neurological events were of grade 1/2, including tremors, confusion, delirium, etc. Twenty-nine percent of patients had grade 3 or higher levels of neurological events. There were 2 treatment-related deaths that occurred on the study; 1 was from hemophagocytic lymphohistiocytosis, while the other was due to cardiac arrest in the setting of CRS. There was a third patient death caused by pulmonary embolism, but this was not related to KTE-C19, he says.



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