Second-Line Tisagenlecleucel or Standard Care in Aggressive B-Cell Lymphoma.
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Bishop Michael R, Dickinson Michael, Purtill Duncan, Barba Pere, Santoro Armando, Hamad Nada, Kato Koji, Sureda Anna, Greil Richard, Thieblemont Catherine, Morschhauser Franck, Janz Martin, Flinn Ian, Rabitsch Werner, Kwong Yok-Lam, Kersten Marie J, Minnema Monique C, Holte Harald, Chan Esther H L, Martinez-Lopez Joaquin, Müller Antonia M S, Maziarz Richard T, McGuirk Joseph P, Bachy Emmanuel, Le Gouill Steven, Dreyling Martin, Harigae Hideo, Bond David, Andreadis Charalambos, McSweeney Peter, Kharfan-Dabaja Mohamed, Newsome Simon, Degtyarev Evgeny, Awasthi Rakesh, Del Corral Christopher, Andreola Giovanna, Masood Aisha, Schuster Stephen J, Jäger Ulrich, Borchmann Peter, Westin Jason R
Аннотация
METHODS: We conducted an international phase 3 trial involving patients with aggressive lymphoma that was refractory to or progressing within 12 months after first-line therapy. Patients were randomly assigned to receive tisagenlecleucel with optional bridging therapy (tisagenlecleucel group) or salvage chemotherapy and autologous hematopoietic stem-cell transplantation (HSCT) (standard-care group). The primary end point was event-free survival, defined as the time from randomization to stable or progressive disease at or after the week 12 assessment or death. Crossover to receive tisagenlecleucel was allowed if a defined event occurred at or after the week 12 assessment. Other end points included response and safety.
RESULTS: A total of 322 patients underwent randomization. At baseline, the percentage of patients with high-grade lymphomas was higher in the tisagenlecleucel group than in the standard-care group (24.1% vs. 16.9%), as was the percentage with an International Prognostic Index score (range, 0 to 5, with higher scores indicating a worse prognosis) of 2 or higher (65.4% vs. 57.5%). A total of 95.7% of the patients in the tisagenlecleucel group received tisagenlecleucel; 32.5% of the patients in the standard-care group received autologous HSCT. The median time from leukapheresis to tisagenlecleucel infusion was 52 days. A total of 25.9% of the patients in the tisagenlecleucel group had lymphoma progression at week 6, as compared with 13.8% of those in the standard-care group. The median event-free survival in both groups was 3.0 months (hazard ratio for event or death in the tisagenlecleucel group, 1.07; 95% confidence interval, 0.82 to 1.40; P = 0.61). A response occurred in 46.3% of the patients in the tisagenlecleucel group and in 42.5% in the standard-care group. Ten patients in the tisagenlecleucel group and 13 in the standard-care group died from adverse events.
CONCLUSIONS: Tisagenlecleucel was not superior to standard salvage therapy in this trial. Additional studies are needed to assess which patients may obtain the most benefit from each approach. (Funded by Novartis; BELINDA ClinicalTrials.gov number, NCT03570892.).