TY - JOUR
T1 - Standard-of-care axicabtagene ciloleucel for relapsed or refractory large B-cell lymphoma
T2 - Results from the US lymphoma CAR T consortium
AU - Nastoupil, Loretta J.
AU - Jain, Michael D.
AU - Feng, Lei
AU - Spiegel, Jay Y.
AU - Ghobadi, Armin
AU - Lin, Yi
AU - Dahiya, Saurabh
AU - Lunning, Matthew
AU - Lekakis, Lazaros
AU - Reagan, Patrick
AU - Oluwole, Olalekan
AU - McGuirk, Joseph
AU - Deol, Abhinav
AU - Sehgal, Alison R.
AU - Goy, Andre
AU - Hill, Brian T.
AU - Vu, Khoan
AU - Andreadis, Charalambos
AU - Munoz, Javier
AU - Westin, Jason
AU - Chavez, Julio C.
AU - Cashen, Amanda
AU - Bennani, N. Nora
AU - Rapoport, Aaron P.
AU - Vose, Julie M.
AU - Miklos, David B.
AU - Neelapu, Sattva S.
AU - Locke, Frederick L.
N1 - Funding Information:
a Moffitt Cancer Center support grant (P30-CA076292), and a National Cancer Institute grant (CA201594).
Funding Information:
Supported by The University of Texas MD Anderson Cancer Center support grant from National Institutes of Health (P30 CA016672),
Publisher Copyright:
Copyright © 2020 American Society of Clinical Oncology. All rights reserved.
PY - 2020/9/20
Y1 - 2020/9/20
N2 - PURPOSE 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. PATIENTS AND METHODS 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. RESULTS 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. CONCLUSION 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.
AB - PURPOSE 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. PATIENTS AND METHODS 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. RESULTS 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. CONCLUSION 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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U2 - 10.1200/JCO.19.02104
DO - 10.1200/JCO.19.02104
M3 - Article
C2 - 32401634
AN - SCOPUS:85086804860
SN - 0732-183X
VL - 38
SP - 3119
EP - 3128
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 27
ER -