Brexucabtagene autoleucel for relapsed/refractory mantle cell lymphoma: Real-world experience from the United States lymphoma CAR T consortium.

Authors

null

Preetesh Jain

Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX

Preetesh Jain , Yucai Wang , Frederick L. Locke , Javier Munoz , Amer Beitinjaneh , Matthew Joshua Frank , Saurabh Dahiya , Miriam T. Jacobs , Brian T Hill , Lazaros J. Lekakis , David Bernard Miklos , Armin Ghobadi , Sattva Swarup Neelapu , Yi Lin , Michael Wang , Michael D. Jain , Matthew J. Maurer

Organizations

Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, Mayo Clinic, Division of Hematology, Rochester, MN, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL, Division of Hematology, Mayo Clinic, Gilbert, AZ, University of Miami, Miami, FL, Stanford University, Stanford, CA, Bay State Medcl Centre, Holyoke, MA, Washington University School of Medicine in St. Louis, St. Louis, MO, Cleveland Clinic Foundation, Cleveland, OH, University of Miami, Sylvester Comprehensive Cancer Center, Miami, FL, Stanford University School of Medicine, Stanford, CA, Washington University School of Medicine, St. Louis, MO, The University of Texas MD Anderson Cancer Center, Department of Lymphoma/Myeloma, Houston, TX, Mayo Clinic, Rochester, MN, The University of Texas MD Anderson Cancer Center, Houston, TX

Research Funding

No funding received

Background: Brexucabtagene autoleucel (BA) is an FDA approved therapy for relapsed/refractory (R/R) mantle cell lymphoma (MCL), based on results from ZUMA-2 study. We report the safety and efficacy of BA in standard of care practice among centers in the US Lymphoma CAR-T Consortium. Methods: 16 centers participated in this retrospective study. Patients (pts) who underwent leukapheresis by 12/31/2021 with an intent to manufacture BA were included. Baseline clinical characteristics, bridging therapy, adverse events after BA infusion, and post-infusion outcome data were collected. Eligibility for ZUMA-2 was retrospectively determined. Survival outcomes were analyzed using the Kaplan-Meier method. Results: At the data cut-off date, 189 pts underwent leukapheresis, among whom 167 (88%) completed BA infusion, 22 (12%) did not receive infusion. The median age was 67 years. 16% had high risk simplified MIPI, 57% had Ki-67≥50%, 41% had aggressive histology, 49% had TP53 alteration, 51% with POD24 and 10% had CNS involvement. The median number of prior lines of therapy was 3 (range 1-10). 86% had prior BTKi treatment (89% refractory). 130 (78%) pts would not have met ZUMA-2 eligibility criteria. 113 (68%) pts received bridging therapy, which included BTKi, venetoclax, chemotherapy. Median time from leukapheresis to lymphodepletion chemotherapy: 28 days (range 17-140). Cytokine release syndrome (CRS) rate was 90% (8% grade ≥3; 1 grade 5), and immune effector cell-associated neurotoxicity syndrome (ICANS) rate was 61% (32% grade ≥3). Grade 5 ICANS (n = 0). Medications used to manage CRS and ICANS were 125 (76%) for tocilizumab, 112 (68%) for corticosteroid, and 27 (16%) for anakinra. 32 (20%) pts required ICU admission, 18 pts required vasopressors, and 5 pts required mechanical ventilation. Day 30 response was evaluable in 155 pts (89% ORR, 70% CR). The best ORR was 89%, with 80% CR, 9% PR. The ORR/CR rates were 88%/79% for aggressive histology, 89%/77% for high Ki-67% (> 50%), 90%/72% for TP53 altered, 81%/75% for CNS involved, 89%/79% for BTKi-exposed, 91%/83% for BTKi-naïve, and 89%/78% for those not meeting ZUMA-2 eligibility criteria. The median duration of response was not reached and at 6-month was 67% (95% CI 57-75). With a median follow-up of 5.6 months (range 0.2-15.3), median PFS was not reached, the 6-month PFS rate was 63% (95% CI 54-71), and median OS was 15.3 months and the 6-month OS rate was 85% (95% CI 77-90). Conclusions: This multicenter retrospective study demonstrated encouraging safety and efficacy data of BA in R/R MCL in the real-world practice. Despite 78% of the pts being ineligible for ZUMA-2, the responses, CRS, ICANS and outcomes were comparable to ZUMA-2 data. Long term safety and efficacy will be reported.

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Abstract Details

Meeting

2022 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

Track

Hematologic Malignancies

Sub Track

Other Lymphoma

Citation

J Clin Oncol 40, 2022 (suppl 16; abstr e19583)

DOI

10.1200/JCO.2022.40.16_suppl.e19583

Abstract #

e19583

Abstract Disclosures