• Jason R Westin, Olalekan O Oluwole, Marie José Kersten, David B Miklos, Miguel-Angel Perales, Armin Ghobadi, Aaron P Rapoport, Anna Sureda, Caron A Jacobson, Umar Farooq, Tom van Meerten, Matthew Ulrickson, Mahmoud Elsawy, Lori A Leslie, Sridhar Chaganti, Michael Dickinson, Kathleen Dorritie, Patrick M Reagan, Joseph McGuirk, Kevin W Song, Peter A Riedell, Monique C Minnema, Yin Yang, Saran Vardhanabhuti, Simone Filosto, Paul Cheng, Shilpa A Shahani, Marco Schupp, Christina To, Frederick L Locke, ZUMA-7 Investigators, and Kite Members.
• From University of Texas M.D. Anderson Cancer Center, Houston (J.R.W.); Vanderbilt-Ingram Cancer Center, Nashville (O.O.O.); Amsterdam University Medical Center (UMC), University of Amsterdam, Cancer Center Amsterdam, Amsterdam (M.J.K.), UMC Groningen, Groningen (T.M.), and UMC Utrecht, Utrecht (M.C.M.) - all in the Netherlands; Stanford University School of Medicine, Stanford (D.B.M.), and Kite, Santa Monica (Y.Y., S.V., S.F., P.C., S.A.S., M.S., C.T.) - both in California; Memorial Sloan Kettering Cancer Center, New York (M.-A.P.), and University of Rochester School of Medicine, Rochester (P.M.R.) - both in New York; Washington University School of Medicine, St. Louis (A.G.); Marlene and Stewart Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (A.P.R.); Servei d'Hematologia Clínica, Institut Català d'Oncologia-Hospitalet, Institut de Recerca Biomèdica de Bellvitge, Universitat de Barcelona, Barcelona (A.S.B.); Dana-Farber Cancer Institute, Boston (C.A.J.); University of Iowa, Iowa City (U.F.); Banner M.D. Anderson Cancer Center, Gilbert, AZ (M.U.); the Division of Hematology and Hematologic Oncology, Department of Medicine, Dalhousie University and Queen Elizabeth II Health Sciences Centre, Halifax, NS (M.E.), and Vancouver General Hospital, BC Cancer, University of British Columbia, Vancouver (K.W.S.) - both in Canada; John Theurer Cancer Center, Hackensack, NJ (L.A.L.); the Centre for Clinical Haematology, University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (S.C.); Peter MacCallum Cancer Centre, Royal Melbourne Hospital, and the University of Melbourne, Melbourne (M.D.); UPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh (K.D.); University of Kansas Cancer Center, Kansas City (J.M.); David and Etta Jonas Center for Cellular Therapy, University of Chicago, Chicago (P.A.R.); and Moffitt Cancer Center, Tampa, FL (F.L.L.).
• N. Engl. J. Med. 2023 Jul 13; 389 (2): 148157148-157.

BackgroundIn an analysis of the primary outcome of this phase 3 trial, patients with early relapsed or refractory large B-cell lymphoma who received axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor T-cell therapy, as second-line treatment had significantly longer event-free survival than those who received standard care. Data were needed on longer-term outcomes.MethodsIn this trial, we randomly assigned patients with early relapsed or refractory large B-cell lymphoma in a 1:1 ratio to receive either axi-cel or standard care (two to three cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem-cell transplantation in patients who had a response). The primary outcome was event-free survival, and key secondary outcomes were response and overall survival. Here, we report the results of the prespecified overall survival analysis at 5 years after the first patient underwent randomization.ResultsA total of 359 patients underwent randomization to receive axi-cel (180 patients) or standard care (179 patients). At a median follow-up of 47.2 months, death had been reported in 82 patients in the axi-cel group and in 95 patients in the standard-care group. The median overall survival was not reached in the axi-cel group and was 31.1 months in the standard-care group; the estimated 4-year overall survival was 54.6% and 46.0%, respectively (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.54 to 0.98; P = 0.03 by stratified two-sided log-rank test). This increased survival with axi-cel was observed in the intention-to-treat population, which included 74% of patients with primary refractory disease and other high-risk features. The median investigator-assessed progression-free survival was 14.7 months in the axi-cel group and 3.7 months in the standard-care group, with estimated 4-year percentages of 41.8% and 24.4%, respectively (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). No new treatment-related deaths had occurred since the primary analysis of event-free survival.ConclusionsAt a median follow-up of 47.2 months, axi-cel as second-line treatment for patients with early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival than standard care. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).Copyright © 2023 Massachusetts Medical Society.

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