European Hematology Association: Clinical and Biologic Covariates of Outcomes in ZUMA-1: A Pivotal Trial of Axicabtagene Ciloleucel (axi-cel; KTE

MADRID, June 24, 2017 /PRNewswire/ --

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 greater than or equal to3 treatment-emergent adverse events were neutropenia (66%), leukopenia (44%), anemia (43%), febrile neutropenia (31%), and encephalopathy (21%). Grade greater than or equal to3 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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Presenter:  Dr Yi Lin

Affiliation:  Mayo Clinic, Rochester, MN, USA

Topic:  CLINICAL AND BIOLOGIC COVARIATES OF OUTCOMES IN ZUMA-1: A PIVOTAL TRIAL OF AXICABTAGENE CILOLEUCEL (AXI-CEL; KTE-C19) IN PATIENTS WITH REFRACTORY AGGRESSIVE NON-HODGKIN LYMPHOMA (NHL)

Abstract S466 will be presented by Yi Lin on Saturday, June 24, 16:00 - 17:15 in Hall C.

About the EHA Annual Congress Hematology is a specialty that covers everything to do with blood: its origin in the bone marrow, diseases of blood and their treatments. The latest data on research and developments will be presented. The topics range from stem cell physiology and development, to leukemia, lymphoma, myeloma - diagnosis and treatment; red blood cells -, white blood cells- and platelet disorders; thrombosis and bleeding disorders.

CONTACT: Contact EHA Executive Office Ineke van der Beek, Jon Tarifa E-mail: communication@ehaweb.org Mobile: +31(0)6 2011 1055

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