Details

Autor(en) / Beteiligte

• O'Reilly, Maeve A.
• Wilson, William
• Burns, David
• Kuhnl, Andrea
• Seymour, Frances
• Uttenthal, Ben
• Besley, Caroline
• Alajangi, Rajesh
• Creasey, Thomas
• Paneesha, Shankara
• Elliot, Johnathon
• Gonzalez Arias, Carlos
• Iyengar, Sunil
• Wilson, Matthew R.
• Delaney, Alison
• Rubio, Lourdes
• Lambert, Jonathan
• Begg, Khalil
• Boyle, Stephen
• Cheok, Kathleen P. L.
• Collins, Graham P.
• Roddie, Claire
• Johnson, Rod
• Sanderson, Robin

Titel

Brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma in the United Kingdom: A real‐world intention‐to‐treat analysis

Ist Teil von

• HemaSphere, 2024-06, Vol.8 (6), p.e87-n/a

Ort / Verlag

Hoboken: John Wiley and Sons Inc

Erscheinungsjahr

2024

Link zum Volltext

Quelle

Alma/SFX Local Collection

Beschreibungen/Notizen

• Brexucabtagene autoleucel (brexu‐cel) is an autologous CD19 CAR T‐cell product, approved for relapsed/refractory (r/r) mantle cell lymphoma (MCL). In ZUMA‐2, brexu‐cel demonstrated impressive responses in patients failing ≥2 lines, including a bruton's tyrosine kinase inhibitor, with an overall and complete response rate of 93% and 67%, respectively. Here, we report our real‐world intention‐to‐treat (ITT) outcomes for brexu‐cel in consecutive, prospectively approved patients, from 12 institutions in the United Kingdom between February 2021 and June 2023, with a focus on feasibility, efficacy, and tolerability. Of 119 approved, 104 underwent leukapheresis and 83 received a brexu‐cel infusion. Progressive disease (PD) and/or manufacturing (MF) were the most common reasons for failure to reach harvest and/or infusion. For infused patients, best overall and complete response rates were 87% and 81%, respectively. At a median follow‐up of 13.3 months, median progression‐free survival (PFS) for infused patients was 21 months (10.1–NA) with a 6‐ and 12‐month PFS of 82% (95% confidence interval [CI], 71–89) and 62% (95% CI, 49–73), respectively. ≥Grade 3 cytokine release syndrome and neurotoxicity occurred in 12% and 22%, respectively. On multivariate analysis, inferior PFS was associated with male sex, bulky disease, ECOG PS > 1 and previous MF. Cumulative incidence of non‐relapse mortality (NRM) was 6%, 15%, and 25% at 6, 12, and 24 months, respectively, and mostly attributable to infection. Outcomes for infused patients in the UK are comparable to ZUMA‐2 and other real‐world reports. However, ITT analysis highlights a significant dropout due to PD and/or MF. NRM events warrant further attention.