Sattva S. Neelapu, MD
The FDA granted a priority review in May to axicabtagene ciloleucel (KTE-C19; axi-cel) for transplant-ineligible patients with relapsed/refractory non-Hodgkin lymphoma (NHL), based on results from the phase II ZUMA-1 trial. The agency is scheduled to make a final approval decision by November 29.
sat down with ZUMA-1 investigator Sattva S. Neelapu, MD, at the 2017 International Conference on Malignant Lymphoma biennial meeting in Lugano, Switzerland. Neelapu, an associate professor in the Department of Lymphoma/Myeloma, Division of Cancer Medicine, at the University of Texas MD Anderson Cancer Center, discussed the chimeric antigen receptor (CAR) T-cell therapy’s potential as a new standard of care for certain patients with NHL.
OncLive: Can you please provide an overview of the primary analysis of the ZUMA-1 trial?
Axi-cel is an autologous CAR T-cell therapy product that has CD3 zeta and CD28 signaling domains, that, when activated, will eliminate any CD19 expressing cells. We evaluated axi-cel in patients with refractory aggressive Hodgkin lymphoma that have a significant unmet clinical need. With existing therapies in these patients, the overall response rate is 26% and the complete response rate is only 8%, with a median survival being only 6.6 months.
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