Dr Westin discusses real-world data with CAR T-cell therapies in R/R DLBCL that were presented at ASH 2021.
Kami Maddocks, MD: I want to briefly go back to Dr Westin. You mentioned real-world data. We talked about safety and efficacy seen in clinical trials. You made a statement about how we have real-world data that show it can be similar in populations of patients who wouldn’t have been eligible for the trial. Do you want to take a few minutes to highlight some of the real-world data and the evidence out there?
Jason Westin, MD: Yes. Thanks, Dr Maddocks. Now that we’ve had access to several of the CAR [chimeric antigen receptor] T cells—axi-cel [axicabtagene ciloleucel] and tisagenlecleucel for a number of years, and liso-cel [lisocabtagene maraleucel] off of clinical trials for the past year—there are increasingly mature data sets looking at patients who have received these in what we call the real world, the CAR T-cell centers. That probably isn’t the best label, to call that the real world, but [it means] off clinical trials. What we’ve seen are remarkably striking similar outcomes from the clinical trials, both in terms of the efficacy—the long-term progression-free and overall survival—as well as the toxicity profile in an increasingly diverse population in terms of their comorbidities and functional status.
We’ve learned a lot from these real-world data sets, in that some patients may not do as well with CAR T cells: those who have comorbidities of organ dysfunction going into some of the CAR T cells, such as axi-cel, or poor performance status. We’ve learned from some of the studies with liso-cel that lower creatinine clearance and lower ejection fraction have been included in some of those trials, and time will tell if their long-term outcomes are similar. But the real-world data sets are probably as close as we’re going to get to a head-to-head randomized trial in the third-line and beyond setting. These registries are being looked at in comparison with each other to try to do propensity matching and see what we can find. In these real-world data sets, all 3 of the CAR T cells—with immature follow-up so far on the liso-cel cohorts—look remarkably similar. It’s great to have lots of options for our patients.
David Miklos, MD, PhD: We’ve simplified the IPI [International Prognostic Index] from many flavors down to performance status and elevated LDH [lactate dehydrogenase] going into lymphodepletion. It’s remarkable how everything that we’ve discussed about double-hits, genetics, and cell of origin—all these other aspects—haven’t shown importance. What’s inside the cell hasn’t shown importance in the immune response. We’re back to LDH, performance status, and age.
Transcript edited for clarity.