Transcript
I'm Lauren Pinter-Brown. I'm a Clinical Professor of Medicine and Dermatology at the Chao Family Comprehensive Cancer Center in the University of California at Irvine. I gave a talk, a very general talk about CAR T, but the question that was posed to me is, which patients with lymphoma should be referred for CAR T therapy?
We began by talking about the structure of the second-generation CAR T products that are FDA-approved and the process of referring a patient for CAR T and how long that might take. Then we focused on the ZUMA-1 trial regarding axi-cel -- because it's the first CAR T that was approved -- what the patient characteristics were, what the trial was.
We looked at the outcome, particularly, the fact that responses were somewhat fluid, that patients could evolve a response over time.
After a period of time, perhaps three months, responses became much more stable, and there were progression-free survival data and overall survival data that suggests that perhaps a patient population is cured.
We of course went over the safety data and some of the side effects that are seen with CAR T such as cytokine release syndrome and neurotoxicity.
We contrasted the outlook with CAR T products in diffused large B-cell lymphoma with the Scholar-1 data that looks at retrospective, Phase 3 data, some institutional data, strongly contrasted with the efficacy of CAR T in a patient population who before this had no particularly good treatment options.
We decided that the standard of care now would be that if a patient had relapsed or refractory diffused large B-cell lymphoma, had already received two systemic therapies -- the same for transformed follicular lymphoma, primary mediastinal B-cell lymphoma or high-grade lymphoma -- that the standard of care at this time would be for referral to CAR T therapy.
We changed gears a little bit and talked about the ZUMA-7 trial that was presented at ASH this year looking at relapsed and refractory mantle cell.
We made specific note that patients who have bad histology such as blastoid mantle cell were included on the trial and that the response rates, complete response rates looked excellent, and if we had a patient with mantle cell lymphoma, since there is no FDA indication currently, that they should be referred to any open trials. We await the FDA evaluation of the data in that case.
Finally, since I have an interest in CD30-positive lymphomas, I will talk briefly about Phase 1 and Phase 2 trials that are occurring in two institutions in the country on anti-CD30 CARs that could be used for patients with Hodgkin's disease who have relapsed-refractory disease, peripheral T-cell lymphoma, SÈzary syndrome, or mycosis fungoides. We'll look to the future for further evidence that these might also be useful in that patient population.
The last thing that we talked about with respect to diffused large B-cell lymphoma is that there currently really isn't evidence to use CAR T cells in a second-line setting. However, there is a protocol looking at this and randomizing against autologous transplantation.
If people are interested in furthering that data to learn if CAR T should be moved forward, we would highly encourage enrollment in those trials of particular patients.
