Résumé
We report results from TRANSCEND FL (NCT04245839) in patients with R/R FL, with safety in all liso-cel–treated patients (ie, second-line or later [2L+]; safety set) and efficacy focused on third-line or later (3L+) patients.
Eligible patients with R/R FL included 3L+ patients and second-line patients with progression within 24 months of diagnosis (POD24) and/or modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria. All patients received ≥1 prior combination systemic therapy, including an anti-CD20 antibody plus alkylator. Patients received liso-cel after lymphodepleting chemotherapy. Bridging therapy was allowed. Primary endpoint was ORR, per independent review committee (IRC), by PET/CT using Lugano 2014 criteria. Secondary endpoints included CR rate, duration of response (DOR), PFS, OS, safety, and PK.
At data cutoff (01/27/2023), of 139 leukapheresed patients, 130 (94%) received liso-cel and 124 (89%) were efficacy evaluable (EE) per IRC. In 3L+ FL patients, 43% had POD24, 53% met GELF criteria, and 64% were double refractory to anti-CD20 antibody plus alkylator. Median (range) prior lines of therapy was 3 (2-10). Median (range) follow-up was 18.9 months (0.3-28.2). In 3L+ EE patients (n=101), the primary endpoint of ORR was met at 97.0% (95% CI, 91.6-99.4; one-sided P<0.0001). CR rate was 94.1% (95% CI, 87.5–97.8; one-sided P<0.0001). With median follow-up of 16.6 and 17.5 months, respectively, median DOR and PFS were not reached; 12-month DOR and PFS were 81.9% and 80.7%, respectively. Efficacy in patients with 2L+ FL was similar. In the safety set (n=130), most common grade ≥3 treatment-emergent adverse events (TEAE) were cytopenias. One TEAE death due to grade 5 macrophage activation syndrome occurred. Cytokine release syndrome (CRS) occurred in 58% of patients (grade 3, 1%; no grade 4-5) and neurological events (NE) in 15% (grade 3, 2%; no grade 4-5). Prolonged cytopenia (grade ≥3 laboratory values at Day 29) occurred in 22% of patients and grade ≥3 infection in 5%.
In patients with R/R FL, liso-cel demonstrated high response rates that were durable and a favorable safety profile, with low rates of grade ≥ 3 TEAEs of CRS/NEs, prolonged cytopenia, and infection.