| Autor: |
Shinichi Makita, Go Yamamoto, Dai Maruyama, Yuki Asano‐Mori, Daisuke Kaji, Revathi Ananthakrishnan, Ken Ogasawara, Lara Stepan, Claudia Schusterbauer, Nils Rettby, Jens Hasskarl, Koji Izutsu |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
|
| Zdroj: |
Cancer Medicine, Vol 11, Iss 24, Pp 4889-4899 (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2045-7634 |
| DOI: |
10.1002/cam4.4820 |
| Popis: |
Abstract The autologous anti‐CD19 chimeric antigen receptor (CAR) T‐cell product, lisocabtagene maraleucel (liso‐cel), is administered at equal target doses of CD8+ and CD4+ CAR+ T cells. This analysis assessed safety and efficacy of liso‐cel in Japanese patients with relapsed or refractory (R/R) aggressive large B‐cell lymphoma (LBCL) in Cohort 3 of TRANSCEND WORLD (NCT03484702). Liso‐cel (100 × 106 total CAR+ T cells) was administered 2–7 days after lymphodepletion. The primary efficacy endpoint was objective response rate (ORR; Lugano 2014 criteria) assessed by an independent review committee. Fourteen patients were enrolled; 10 received liso‐cel infusion (median time to liso‐cel availability, 23 days) and were evaluable at data cutoff (median follow‐up, 12.5 months). Grade ≥ 3 treatment‐emergent adverse events were neutropenia (90%), leukopenia (80%), anemia (70%), and thrombocytopenia (70%). All‐grade cytokine release syndrome (CRS) was observed in 50% of patients, though no grade ≥3 CRS events were reported. Grade 1 neurological events occurred in 1 patient but were resolved without any intervention. Prolonged cytopenia (grade ≥ 3 at day 29) was reported for 60% of patients. The ORR was 70%, and complete response rate was 50%. The median duration of response was 9.1 months (95% confidence interval [CI], 2.1—not reached), and overall survival was 14.7 months (95% CI, 1.7—not reached). One patient diagnosed with central nervous system involvement after screening but before liso‐cel infusion, responded to liso‐cel. Liso‐cel demonstrated meaningful efficacy and a manageable safety profile in Japanese patients with R/R LBCL. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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