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Outpatient Administration Potential of CAR T-Cell Therapy

Panelists: David Maloney, MD, PhD, Fred Hutchinson Cancer Research Center; Nilanjan Ghosh, MD, PhD, Levine Cancer Institute/Atrium Health; Leo I. Gordon, MD, FACP, Robert H. Lurie Comprehensive Cancer Center; Matthew Lunning, DO, University of Nebraska Medical Center; Michael Pulsipher, MD Children
Published: Wednesday, Jan 30, 2019



Transcript: 

David Maloney, MD, PhD: All right, so I’m going to transition slightly. We have 2 products, a third in clinical trials. Right now this is pretty intensive care required, both intensive hospitalizations as well as intensive care units [ICUs]. At least with axicabtagene ciloleucel, what’s the potential for outpatient administration of these treatments?

Leo I. Gordon, MD, FACP: I think you probably can speak to that best, but I think that’s the goal, especially if you can identify a patient population that may be less bulky that you would expect to have less cytokine release syndrome [CRS] and neurologic toxicity. And I think, and I’ll let you speak to it, you have to have a center set up so that you have 24/7 availability of medical personnel, and I think your center at Fred Hutchinson Cancer Research Center is doing that.

Matthew Lunning, DO: I think it goes beyond to where your center evolves into your [emergency department]. But if you’re going to do outpatient CAR T-cell therapy, they can end up in the emergency [department] despite all the best efforts of trying to get them to your respective treatment centers. And so if you’re going to do outpatient CARs early on, we’re all doing this in broad education at our centers.

Michael Pulsipher, MD: Right. Now we’ve actually evolved to do that, and I think that Hutch has done that too. We started only with inpatient and once we got comfortable, we had to put a system in. And everyone was nervous. It was a problem, it was a challenge, but we worked it out so all our patients are tagged. They have a band on that shows the emergency department. If they’re a CAR T-cell patient, we have a notification process. But once the outpatient team was trained and got good at managing it, we now feel very comfortable starting outpatient, because if they have a problem they come in immediately.

David Maloney, MD, PhD: So that’s with a 4-1BB CAR.

Michael Pulsipher, MD: Correct.

David Maloney, MD, PhD: I think the data right now are with the JULIET trial. I think about 25% of those patients were actually treated as an outpatient. And we have actually quite a bit of experience now with the commercial tisagenlecleucel where we can deliver that as an outpatient, and it functions very similar to our experience with earlier 4-1BB CARs or JCAR017. When we do that, you admit patients at the first sign of something going wrong, so that’s almost always a fever. And so we’ve been able to do that and people get admitted somewhere between day 3 and 7, or not at all, and we have about 30% of patients who can stay out of hospital the whole time without having significant issues.

With the JCAR017, we have now increasing experience across some of the centers in New York. And I don’t know whether you guys have experience with that yet. But we’ve been able to treat most patients as an outpatient, and admit them at the first sign of symptoms And they usually don’t require escalation of care into an ICU. But I think a lot of this is because it’s different products. I think the tisagenlecleucel and the lisocabtagene maraleucel are different products than axicabtagene ciloleucel, and that CD28 versus the 4-1BB makes a big difference. And I have not treated any patients with axicabtagene out of the hospital and most of them get CRS really quickly, and they’re in there at least a couple of weeks.

Michael Pulsipher, MD: I totally agree. Right now we’re just doing the studies on the CD28s and we keep them in-house.

David Maloney, MD, PhD: I think that’s a key issue. But at some point if we have these other products approved, then this will come into play in terms of resource utilization. And we presented a little bit showing that you can get by with much fewer days in the ICU, much fewer days in the hospital, and you would think that that will eventually translate into healthcare utilization, cost of delivering this type of treatment.

Transcript Edited for Clarity 

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Transcript: 

David Maloney, MD, PhD: All right, so I’m going to transition slightly. We have 2 products, a third in clinical trials. Right now this is pretty intensive care required, both intensive hospitalizations as well as intensive care units [ICUs]. At least with axicabtagene ciloleucel, what’s the potential for outpatient administration of these treatments?

Leo I. Gordon, MD, FACP: I think you probably can speak to that best, but I think that’s the goal, especially if you can identify a patient population that may be less bulky that you would expect to have less cytokine release syndrome [CRS] and neurologic toxicity. And I think, and I’ll let you speak to it, you have to have a center set up so that you have 24/7 availability of medical personnel, and I think your center at Fred Hutchinson Cancer Research Center is doing that.

Matthew Lunning, DO: I think it goes beyond to where your center evolves into your [emergency department]. But if you’re going to do outpatient CAR T-cell therapy, they can end up in the emergency [department] despite all the best efforts of trying to get them to your respective treatment centers. And so if you’re going to do outpatient CARs early on, we’re all doing this in broad education at our centers.

Michael Pulsipher, MD: Right. Now we’ve actually evolved to do that, and I think that Hutch has done that too. We started only with inpatient and once we got comfortable, we had to put a system in. And everyone was nervous. It was a problem, it was a challenge, but we worked it out so all our patients are tagged. They have a band on that shows the emergency department. If they’re a CAR T-cell patient, we have a notification process. But once the outpatient team was trained and got good at managing it, we now feel very comfortable starting outpatient, because if they have a problem they come in immediately.

David Maloney, MD, PhD: So that’s with a 4-1BB CAR.

Michael Pulsipher, MD: Correct.

David Maloney, MD, PhD: I think the data right now are with the JULIET trial. I think about 25% of those patients were actually treated as an outpatient. And we have actually quite a bit of experience now with the commercial tisagenlecleucel where we can deliver that as an outpatient, and it functions very similar to our experience with earlier 4-1BB CARs or JCAR017. When we do that, you admit patients at the first sign of something going wrong, so that’s almost always a fever. And so we’ve been able to do that and people get admitted somewhere between day 3 and 7, or not at all, and we have about 30% of patients who can stay out of hospital the whole time without having significant issues.

With the JCAR017, we have now increasing experience across some of the centers in New York. And I don’t know whether you guys have experience with that yet. But we’ve been able to treat most patients as an outpatient, and admit them at the first sign of symptoms And they usually don’t require escalation of care into an ICU. But I think a lot of this is because it’s different products. I think the tisagenlecleucel and the lisocabtagene maraleucel are different products than axicabtagene ciloleucel, and that CD28 versus the 4-1BB makes a big difference. And I have not treated any patients with axicabtagene out of the hospital and most of them get CRS really quickly, and they’re in there at least a couple of weeks.

Michael Pulsipher, MD: I totally agree. Right now we’re just doing the studies on the CD28s and we keep them in-house.

David Maloney, MD, PhD: I think that’s a key issue. But at some point if we have these other products approved, then this will come into play in terms of resource utilization. And we presented a little bit showing that you can get by with much fewer days in the ICU, much fewer days in the hospital, and you would think that that will eventually translate into healthcare utilization, cost of delivering this type of treatment.

Transcript Edited for Clarity 
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