Phase 2 results of lisocabtagene maraleucel in Japanese patients with relapsed/refractory aggressive B‐cell <scp>non‐Hodgkin</scp> lymphoma
Shinichi Makita, Go Yamamoto, Dai Maruyama, Yuki Asano‐Mori, Daisuke Kaji, Revathi Ananthakrishnan, K. OGASAWARA, Lara Stepan, Claudia Schusterbauer, Nils Rettby, Jens Hasskarl, Koji Izutsu
Abstract
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 × 10 6 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.