The Annals of pharmacotherapy · 2021
Brexucabtagene Autoleucel: A Novel Chimeric Antigen Receptor T-cell Therapy for the Treatment of Mantle Cell Lymphoma.
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Anderson Mary Kate, Torosyan Annie, Halford Zachery
Аннотация
OBJECTIVE: To identify and assess the current literature surrounding the safety, efficacy, and practical considerations of brexucabtagene autoleucel (brexu-cel) for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (MCL).
DATA SOURCES: An English-based literature search was conducted using the terms "brexucabtagene autoleucel" AND "mantle cell lymphoma" OR "KTE-X19"in PubMed (inception through May 1, 2021), EMBASE (inception through May 1, 2021), and ClinicalTrials.gov.
STUDY SELECTION AND DATA EXTRACTION: All studies evaluating the use of brexu-cel in MCL were considered for inclusion.
DATA SYNTHESIS: In the pivotal ZUMA-2 trial, brexu-cel demonstrated objective response and complete response rates of 85% and 59%, respectively. These results were consistent among high-risk subgroups. Noteworthy treatment-related adverse effects included grade ≥3 cytopenias (94%), immune effector cell-associated neurotoxicity syndrome (31%), and cytokine release syndrome (15%). Brexu-cel elicited a toxicity profile similar to that of other novel chimeric antigen receptor (CAR) T-cell products, with no new safety signals.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: There are currently no head-to-head clinical trials evaluating brexu-cel against other approved subsequent-line options in r/r MCL. In a relatively small phase II trial, brexu-cel demonstrated impressive response rates in heavily pretreated patients, with few viable alternatives. Long-term safety and efficacy outcomes with brexu-cel are unknown. The prevention, identification, and management of unique CAR T-cell toxicities requires expert care from a well-trained interdisciplinary team.
CONCLUSION: Brexu-cel has emerged as a viable treatment option in MCL. Additional studies are required to determine the optimal sequencing and place in therapy for brexu-cel in this highly heterogeneous, pathobiologically distinct, and incurable malignancy.
DATA SOURCES: An English-based literature search was conducted using the terms "brexucabtagene autoleucel" AND "mantle cell lymphoma" OR "KTE-X19"in PubMed (inception through May 1, 2021), EMBASE (inception through May 1, 2021), and ClinicalTrials.gov.
STUDY SELECTION AND DATA EXTRACTION: All studies evaluating the use of brexu-cel in MCL were considered for inclusion.
DATA SYNTHESIS: In the pivotal ZUMA-2 trial, brexu-cel demonstrated objective response and complete response rates of 85% and 59%, respectively. These results were consistent among high-risk subgroups. Noteworthy treatment-related adverse effects included grade ≥3 cytopenias (94%), immune effector cell-associated neurotoxicity syndrome (31%), and cytokine release syndrome (15%). Brexu-cel elicited a toxicity profile similar to that of other novel chimeric antigen receptor (CAR) T-cell products, with no new safety signals.
RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: There are currently no head-to-head clinical trials evaluating brexu-cel against other approved subsequent-line options in r/r MCL. In a relatively small phase II trial, brexu-cel demonstrated impressive response rates in heavily pretreated patients, with few viable alternatives. Long-term safety and efficacy outcomes with brexu-cel are unknown. The prevention, identification, and management of unique CAR T-cell toxicities requires expert care from a well-trained interdisciplinary team.
CONCLUSION: Brexu-cel has emerged as a viable treatment option in MCL. Additional studies are required to determine the optimal sequencing and place in therapy for brexu-cel in this highly heterogeneous, pathobiologically distinct, and incurable malignancy.