ASH Clinical News ACN_5.1_Digital - Page 40

NOW ENROLLING R/R DLBCL PATIENTS FOR THE 2L ZUMA-7 CAR T-CELL STUDY ZUMA-7 is a global, phase 3, randomized study evaluating the effi cacy of axicabtagene ciloleucel versus standard-of-care therapy in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) Study Design Primary Endpoint Event-free survival ‡ Secondary Endpoints Objective response rate Overall survival Progression-free survival Duration of response Patient-reported outcomes Safety Key Eligibility Criteria • Patients ≥18 years old with histologically proven DLBCL (including transformation from FL) • Adequate 1L therapy • Relapsed/refractory after 1L chemoimmunotherapy — Refractory disease defi ned as no CR to 1L therapy — Relapsed disease defi ned as CR to 1L therapy followed by biopsy-proven disease or relapse ≤12 months after initiation of 1L therapy • Patients who previously received CD19-targeted therapy, CAR of other genetically modifi ed T-cell therapy, ASCT, or allogeneic SCT are ineligible to enroll • Intent to proceed to HDT and ASCT • ECOG performance score of 0 or 1 • Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function Contact for clinical trial inquiries and view other clinical trials at Visit for more information on trial inclusion and exclusion criteria. NCT03391466 The safety and effi cacy of these investigational agents and/or uses have not been established. * Patients will receive a 3-day lymphodepleting chemotherapy regimen consisting of fl udarabine 30 mg/m 2 /d + cyclophosphamide 500 mg/m 2 /d (days -5 to -3) followed by 2 days rest (days -2 and -1). On day 0, patients will receive a single infusion of axi-cel administered intravenously at 2 x 10 6 anti-CD19 CAR T cells/kg. Patients will receive 2-3 cycles of investigator’s choice of a platinum-based combination chemotherapy regimen (eg, R-ICE) administered every 2-3 weeks. ‡ Event is defined as death, disease progression, or new lymphoma therapy. † 1L=fi rst line; 2L=second line; ASCT=autologous stem cell transplant; CAR=chimeric antigen receptor; CR=complete response; DLBCL=diff use large B-cell lymphoma; ECOG=Eastern Cooperative Oncology Group; FL=follicular lymphoma; HDT=high-dose therapy; SCT=stem cell transplant. Reference: Oluwole OO, et al. J Clin Oncol . 2018;36(suppl). Abstract TPS7585. KITE and the KITE Logo are trademarks of Kite Pharma, Inc. GILEAD is a trademark of Gilead Sciences, Inc. © 2018 Kite Pharma, Inc. All rights reserved. MRC-00138 10/2018 Santa Monica, CA