Top Line: Is CAR T-cell therapy effective for a broader population of patients with relapsed or refractory B-cell lymphomas?
The Study: Two CD-19 directed CAR T-cell therapies (yescarta and kymriah) are approved for treatment of relapsed or refractory B-cell lymphoma. TRANSCEND NHL 001 is the largest CAR T trial to date for relapsed/refractory B-cell lymphoma and it included a broad population of nearly 350 patients (40% 65 years or older, most with 3+ lines of prior therapy, and most with chemo-refractory disease). They underwent leukopheresis to generate a CD4+/CD8+ CAR T cell product called lisocabtagene maraleucel (liso-cel). Median time to manufacture was 24 days and time to infusion was 37 days. Roughly 15% of patients didn’t receive liso-cel due to death or complication prior to administration. Key toxicities with CAR T-cell therapy are cytokine release syndrome and neurological events, which were 42% and 30%, respectively in TRANSCEND. Most cytokine release syndrome events were mild (2% rate of grade 3+). Among patients who actually received liso-cel, the objective response rate (both partial and complete responses) was 73% with a 53% CR rate, and most responses were apparent as early as 1 month. At 12 months, the ongoing response rate was 55% and median duration of response had not been reached. These outcomes, and particularly toxicity, compare favorably with yescarta (ZUMA-1) and kymriah (JULIET) in a broader cohort of patients and histologies.
TBL: Liso-cel is a CD-19 directed CAR T-cell therapy with favorable response rate and toxicity in a broad population of patients with heavily pre-treated B-cell lymphoma. | Abramson, Lancet 2020