Key points are not available for this paper at this time.
7016 Background: In the TRANSCEND-MCL (NCT02631044) primary analysis, the CD19-directed, CAR T cell product liso-cel demonstrated a high, durable CR rate (CRR) with manageable safety in pts with heavily pretreated R/R MCL. Here, we report outcomes by number of prior LOTs and by response to prior BTKi. Methods: Pts had PET-positive R/R MCL after ≥ 2 prior systemic LOTs, including BTKi, alkylating, and CD20-targeted agents. Pts received liso-cel after lymphodepleting chemotherapy. Bridging therapy was allowed. Primary endpoints were treatment-emergent AEs (TEAE) and ORR by independent review committee (IRC) per Lugano 2014 criteria; secondary endpoints included CRR, duration of response (DOR), PFS, and OS. Results: 88 pts received liso-cel. Median follow-up was 16.1 mo (range, 0.4–60.5). For all pts, CRR was 72%; median DOR, PFS, and OS were 15.7, 15.3, and 18.2 mo, respectively (Table). ORR, CRR, and median DOR, PFS, and OS were similar to all pts for most subgroups, but numerically lower in pts with ≥ 5 prior LOTs and pts refractory to prior BTKi. Grade (gr) ≥ 3 TEAEs ranged from 67–96% across subgroups, similar to all pts (86%); most common gr ≥ 3 TEAE was neutropenia (33–58%). Most cytokine release syndrome (CRS) and neurological events (NE) were gr 1–2 (Table) with no gr 5 CRS/NE. Gr ≥ 3 infection (11–19%) and prolonged cytopenia (32–50%) in subgroups were similar to all pts (15% and 40%). Cellular kinetics will be presented. Conclusions: In TRANSCEND-MCL, all subgroups benefited from liso-cel and responses were generally comparable to the overall population, with numerically shorter duration in pts with ≥ 5 prior LOTs and disease refractory to prior BTKi, supporting study of liso-cel in earlier LOTs. Clinical trial information: NCT02631044 . Table: see text
Palomba et al. (Sat,) studied this question.