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 ≥3 treatment-emergent adverse
events were neutropenia (66%), leukopenia (44%), anemia (43%),
febrile neutropenia (31%), and encephalopathy (21%). Grade ≥3
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.
SOURCE European Hematology Association