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Nastoupil, Loretta J; Jain, Michael D; Feng, Lei; Spiegel, Jay Y; Ghobadi, Armin; Lin, Yi; Dahiya, Saurabh; Lunning, Matthew; Lekakis, Lazaros; Reagan, Patrick; Oluwole, Olalekan; McGuirk, Joseph; Deol, Abhinav; Sehgal, Alison R; Goy, Andre; Hill, Brian T; Vu, Khoan; Andreadis, Charalambos; Munoz, Javier; Westin, Jason; Chavez, Julio C; Cashen, Amanda; Bennani, N Nora; Rapoport, Aaron P; Vose, Julie M; Miklos, David B; Neelapu, Sattva S; Locke, Frederick L
Journal of clinical oncology, 09/2020, Volume: 38, Issue: 27Journal Article
Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and complete response rates in infused patients of 83% and 58%, respectively. We report clinical outcomes with axi-cel in the standard-of-care (SOC) setting for the approved indication. Data were collected retrospectively from all patients with relapsed/refractory LBCL who underwent leukapheresis as of September 30, 2018, at 17 US institutions with the intent to receive SOC axi-cel. Toxicities were graded and managed according to each institution's guidelines. Responses were assessed as per Lugano 2014 classification. Of 298 patients who underwent leukapheresis, 275 (92%) received axi-cel therapy. Compared with the registrational ZUMA-1 trial, 129 patients (43%) in this SOC study would not have met ZUMA-1 eligibility criteria because of comorbidities at the time of leukapheresis. Among the axi-cel-treated patients, grade ≥ 3 cytokine release syndrome and neurotoxicity occurred in 7% and 31%, respectively. Nonrelapse mortality was 4.4%. Best overall and complete response rates in infused patients were 82% (95% CI, 77% to 86%) and 64% (95% CI, 58% to 69%), respectively. At a median follow-up of 12.9 months from the time of CAR T-cell infusion, median progression-free survival was 8.3 months (95% CI, 6.0 to15.1 months), and median overall survival was not reached. Patients with poor Eastern Cooperative Oncology Group performance status of 2-4 and elevated lactate dehydrogenase had shorter progression-free and overall survival on univariable and multivariable analysis. The safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial.
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