ASH 2023 | TRANSCEND FL: liso-cel as 2L therapy in patients with high-risk R/R follicular lymphoma

So TRANSCEND FL is a single arm Phase II study looking at lisocabtagene maraleucel, which is a CD19 4-1BB auto CAR-T cell therapy for relapsed/refractory follicular lymphoma. Now, clearly, CAR-T has transformed how we approach large cell lymphoma, but those patients outcomes are so poor, it’s an easy discussion to have when CAR-T is appropriate. I think it’s much harder to define the patient population where you would consider a resource intense, potentially toxic therapy in indolent lymphoma, when most of those patients are going to face normal life expectancies with the available treatment options.

So this is a single arm Phase II, trying to explore different cohorts of patients where you could make an argument that CAR-T could potentially be impactful. So second-line patients who progressed within 24 months of chemoimmunotherapy or have GELF criteria, and then we have a third-line cohort and a fourth-line cohort.

So the summer meetings, we saw the safety for all of these patients, and then we saw the efficacy reported for that third-line or later cohorts. This year at ASH we’re going to see the second-line safety and efficacy data, and also kind of compare and contrast that a little bit with those third-line or later patients. Again, it’s not a randomized study, there wasn’t matching in those baseline characteristics, they’re clearly going to be different for patients that are enrolled at an earlier time point. But it looks like those outcomes, particularly for those POD24 patients in second-line, are quite favorable.

So I’m excited to see where the future goes. We’re anticipating an FDA approval for liso-cel. We don’t know exactly what the patient population is going to be, but the third-line, or sorry, the randomized Phase III is now launched, which is liso-cel versus standard-of-care, second-line, third-line or fourth-line patients.