Agasti 2021: I-FDA inikeze axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) ukuvunyelwa okusheshayo kweziguli ezindala ezine-folloma lymphoma (FL) ebuyele emuva noma ephikisayo ngemuva kwemigqa emibili noma ngaphezulu yokwelashwa kwesistimu.
A single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) evaluated axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory FL after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent, in adult patients with relapsed A single intravenous infusion of axicabtagene ciloleucel was given after lymphodepleting chemotherapy.
Ikomidi lokubuyekeza elingakhethi lichaze izinyathelo ezinkulu zokusebenza kahle: isilinganiso sokuphendula ngenhloso (ORR) nobude besikhathi sokuphendula (i-DOR). I-ORR ibingamaphesenti angama-91 (amaphesenti angama-95 we-CI: 83, 96) phakathi kweziguli ezingama-81 ekuhlaziyweni okuyisisekelo kokusebenza, ngesilinganiso esiphelele sokuxolelwa (CR) samaphesenti angama-60 kanye nesikhathi sokuphendula esiphakathi kwenyanga eyodwa. I-DOR yasemkhathini ayifinyelelwanga, kanti amaphesenti we-76.2 weziguli ahlala ekhululiwe ngemuva konyaka owodwa (amaphesenti angama-95 we-CI: 63.9, 84.7). I-ORR ibingamaphesenti angama-89 (amaphesenti angama-95 e-CI: 83, 94) kuzo zonke iziguli ezinama-leukapheresed kuleli cala (n = 123), ngezinga le-CR lamaphesenti angama-62.
A boxed warning for i-cytokine release syndrome (CRS) and neurologic toxicities is included in the prescribing material for axicabtagene ciloleucel. CRS occurred in 88 percent (Grade 3, 10%) of patients with non-lymphoma Hodgkin’s (NHL) in investigations using axicabtagene ciloleucel, while neurologic toxicities occurred in 81 percent (Grade 3, 26 percent). CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, febrile neutropenia, nausea, infections with pathogen unspecified, decreased appetite, chills, diarrhoea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmias, and dizziness are the most common non-laboratory adverse reactions (incidence 20%) in patients with NHL.
