Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma.
The New England journal of medicine
washington; seattle; swedish cancer
BACKGROUND: The prognosis of patients with early relapsed or refractory large B-cell lymphoma after the receipt of first-line chemoimmunotherapy is poor.
METHODS: In this international, phase 3 trial, we randomly assigned, in a 1:1 ratio, patients with large B-cell lymphoma that was refractory to or had relapsed no more than 12 months after first-line chemoimmunotherapy to receive axicabtagene ciloleucel (axi-cel, an autologous anti-CD19 chimeric antigen receptor T-cell therapy) or standard care (two or three cycles of investigator-selected, protocol-defined chemoimmunotherapy, followed by high-dose chemotherapy with autologous stem-cell transplantation in patients with a response to the chemoimmunotherapy). The primary end point was event-free survival according to blinded central review. Key secondary end points were response and overall survival. Safety was also assessed.
RESULTS: A total of 180 patients were randomly assigned to receive axi-cel and 179 to receive standard care. The primary end-point analysis of event-free survival showed that axi-cel therapy was superior to standard care. At a median follow-up of 24.9 months, the median event-free survival was 8.3 months in the axi-cel group and 2.0 months in the standard-care group, and the 24-month event-free survival was 41% and 16%, respectively (hazard ratio for event or death, 0.40; 95% confidence interval, 0.31 to 0.51; P
CONCLUSIONS: Axi-cel therapy led to significant improvements, as compared with standard care, in event-free survival and response, with the expected level of high-grade toxic effects. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, NCT03391466.).
Locke, Frederick L; Miklos, David B; Jacobson, Caron A; Perales, Miguel-Angel; Kersten, Marie-José; Oluwole, Olalekan O; Ghobadi, Armin; Rapoport, Aaron P; McGuirk, Joseph; Pagel, John M; Muñoz, Javier; Farooq, Umar; van Meerten, Tom; Reagan, Patrick M; Sureda, Anna; Flinn, Ian W; Vandenberghe, Peter; Song, Kevin W; Dickinson, Michael; Minnema, Monique C; Riedell, Peter A; Leslie, Lori A; Chaganti, Sridhar; Yang, Yin; Filosto, Simone; Shah, Jina; Schupp, Marco; To, Christina; Cheng, Paul; Gordon, Leo I; Westin, Jason R; and All ZUMA-7 Investigators and Contributing Kite Members, "Axicabtagene Ciloleucel as Second-Line Therapy for Large B-Cell Lymphoma." (2021). Articles, Abstracts, and Reports. 5582.