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 medinfo@kitepharma.com for clinical trial inquiries and view other clinical trials at kitepharma.com/pipeline. Visit clinicaltrials.gov for more information on trial inclusion and exclusion criteria. Clinicaltrials.gov: 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