Résumé
We report subgroup analyses by number of prior LOTs, POD24 status, and prior bendamustine exposure in liso-cel–treated patients from the FL cohort of TRANSCEND FL.
Patients had 3L+ or high-risk 2L R/R FL (PD ≤24 mo of diagnosis and treatment ≤6 mo of FL diagnosis, and/or modified GELF criteria) after prior treatment with anti-CD20 antibody and alkylator. Informed consent was obtained. Post hoc subgroup efficacy/safety analyses were performed by number of prior LOTs (4L+/3L/2L), POD24 (yes/no) and bendamustine exposure (<12 mo/12–24 mo/>24 mo before leukapheresis/no bendamustine). In bendamustine subgroups, cellular kinetics were assessed.
Of 130 liso-cel–treated patients, 45%/37%/18% received liso-cel as 4L+/3L/2L treatment; 56% had POD24 and 43% did not; 8%/8%/38%/45% had prior bendamustine <12 mo/12‒24 mo/>24 mo before leukapheresis/no bendamustine. Median on-study follow-up was 29.7 mo (range, 0.3‒39.6). No major differences in subgroup demographics/baseline characteristics were observed. ORR was ≥96% across subgroups. CR rate was similar across prior LOTs (93%‒96%) and POD24 subgroups (94% each), but lower in patients with prior bendamustine <12 mo (75%; n = 8) versus other bendamustine subgroups (95%‒100%). A trend toward better 24-mo DOR/PFS/OS was observed in earlier LOTs (4L+, 73%/71%/87%; 3L, 76%/75%/89%; 2L, 86%/83%/96%). 24-mo DOR/PFS/OS was slightly better in patients without POD24 (87%/85%/94%), though clinically meaningful in patients with POD24 (70%/67%/86%). 24-mo DOR/PFS/OS was high for bendamustine subgroups (12‒24 mo subgroup, 72%/72%/91%; >24 mo subgroup, 82%/79%/88%; no bendamustine subgroup, 77%/74%/93%) except 8 patients with prior bendamustine <12 mo (50%/50%/71%). 24-mo TTNT was numerically lower for patients with 4L+ versus 3L and versus 2L FL (76%/85%/91%), POD24 versus no POD24 (78%/89%), and prior bendamustine <12 mo versus other bendamustine subgroups (58%/91%/81%/85%). Cellular kinetics were similar among bendamustine subgroups. Safety was consistent across subgroups with low rates of grade ≥3 cytokine release syndrome (0%‒2%), neurological events (0%‒9%), second primary malignancies (0%‒ 11%), grade ≥3 infections (4%‒18%), prolonged cytopenia (90d, 4%‒25%), and no new signals observed.
Data support sustained clinical benefit and manageable safety of liso-cel in patients with R/R FL, regardless of POD24 and prior bendamustine, trending towards better outcomes in earlier LOTs.
Celgene, a Bristol-Myers Squibb Company.