SOHO 2023 | Liso-cel for R/R follicular lymphoma: TRANSCEND FL update

We reported the Phase II results of liso-cel, which is a CD19 auto-CAR with equal parts of CD4 and CD8, administered as a single infusion for patients with relapsed/refractory follicular. So there were several different cohorts, but to be eligible for the study, you had to have at least one prior line of chemoimmunotherapy, good organ function, and good performance status. For the second-line cohort, you also had to have POD24 or meet GELF criteria. There was a third-line cohort and then a fourth-line plus cohort. What we presented is the safety results for the entire cohort. So second-line plus and then the efficacy results for third-line plus. If you look at the baseline characteristics between those two different designations, they are pretty similar with the exception of median prior lines of therapy. Mostly, the population is younger patients, pretty heavily pretreated, chemo refractory, over-enriched with POD24. About 40% did have bridging, so it gives you a sense that these were patients that were in need of therapy. The safety looks really good, particularly for a CAR-T. There was one patient with grade 3 CRS, but the majority had grade 1 CRS, which resolves. Median time of onset is a little bit longer than with the CD28-CAR, so that lends itself to outpatient infusion. Only 5% have hypogammaglobulinemia. Despite 22% having cytopenias, the vast majority recovered by day 90, and the rates of grade 3 or higher infection were quite low, so only about 5%. So, in general, the safety looks really good and the efficacy is pretty phenomenal at this point. Though it’s a relatively short follow-up, but 97% objective response rate and 94% complete response. So nearly all responded except for three, all the rest had CR, so that is pretty impressive.