Axicabtagene Ciloleucel: Clinical Data for the Use of CAR T cell Therapy in Relapsed and Refractory Large B cell Lymphoma
Objective To evaluate the literature for axicabtagene ciloleucel (axi cel) a first in class chimeric antigen receptor (CAR) T cell therapy, in the treatment of relapsed/refractory (r/r) large B cell lymphoma (LBCL) Data Sources We conducted a PubMed (inception to June 22, 2020) and ClinicalTrials.gov search using the following terms: CD19, chimeric antigen receptor, and lymphoma. Study Selection and Data Extraction All retrospective and prospective studies evaluating the use of axi cel in LBCL were reviewed. Data Synthesis In the pivotal ZUMA 1 trial, axi cel exhibited unprecedented overall and complete response rates of 83% and 58% respectively. With a median follow up of 27.1 months, 39% of patients had ongoing responses. Furthermore, postmarketing retrospective analyses found similar response rates in a more clinically diverse LBCL patient population. Novel CAR T cell therapy elicits unique and potentially life threatening toxicities that include cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) Studies reported grade =3 CRS in 7% to 14% of patients and grade =3 ICANS in 31% to 55% of patients. Relevance to Patient Care and Clinical Practice Axi cel was the first US Food and Drug Administration approved genetically engineered autologous CAR T cell agent in r/r LBCL, representing an important milestone and paradigm shift in cancer treatment. Adoptive T cell immunotherapy is a breakthrough treatment modality requiring careful patient selection, multidisciplinary collaboration, comprehensive patient counseling, and expert training to ensure optimal treatment. Conclusions The initial and ongoing results with axi cel are encouraging, but long term safety and efficacy data are lacking. Additional studies are required to identify axi cel's ideal place in LBCL therapy.
The Annals of pharmacotherapy