Octobris 2021 : Brexucabtagne autoleucel (Tecartus, Kite Pharma, Inc.) has been approved by the Food and Drug Administration for adult patients with relapsed or refractory B-cell precursor acuta lymphoblastic leukemia (ALL).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor oMNIS, the efficacy of brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell treatment, was assessed. Following lymphodepleting chemotherapy, patients received a single infusion of brexucabtagene autoleucel.
Completa responsio (CR) intra 3 menses infusionis et firmitatis CR erant efficacia exitus criteria adhibita ad probationem fulciendam. Intra tres menses, 28 (52 percent; 95 percent CI: 38, 66) aegrorum 54 pro efficacia pervenerunt CR. Mediana periodus CR non occurrit cum sequela mediana 7.1 mensuum respondentium; longitudo CR praeventus est plusquam dimidium aegrorum 12 mensium superare.
Monitum cohibenti cytokine syndrome release (CRS) and neurologic toxicities is included in the prescribing material for brexucabtagene autoleucel. In 92 percent of cases (Grade 3, 26 percent), CRS developed, and in 87 percent of cases (Grade 3, 35 percent), neurologic toxicities occurred. Fever, CKS, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhoea, musculoskeletal pain, hypoxia, rash, edoema, tremor, infection with an unspecified pathogen, constipation, decreased appetite, and vomiting were the most common non-laboratory adverse reactions (incidence 20%).
A single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight (maximum 1 x 108 CAR-positive viable T cells) is advised for brexucabtagen autoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
