Round 3—Can Community Practices Adopt and Sustain the Use of Bispecific Antibody Therapy in Late-Line Multiple Myeloma?

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Charise Gleason: We're going to talk now about whether we can start seeing these more out in the community and whether they can adopt and sustain bispecific therapies. And I think they can. And I am on a committee with several physicians from across the country, and we're putting together a paper. I mean, the push is to get this out to the community. We can't just do this at academic centers. You cannot leave these treatments off the table for all these patients if you don't get it out in the community center. And I think we've shown you that if you just put protocols around it and educate, you really can do it. And partner, I mean, I think academic centers are happy to partner with their community teams.  

Beth Faiman: And you're a Vice President at Emory, so…  

Charise Gleason: I don't know what it has to do with anything. But…  

Beth Faiman: You know about the risk and the reward, the legal considerations, and all the other considerations.  

Charise Gleason: That is true. That is true. We all have referral patterns, and even right now, we're doing a lot of it, and then we're sending you back to the community. We really need the community to get comfortable with doing this. So, there starts now with an abundance of new data that's coming out from the community centers' publishing. You're going to see the same sort of things that we've seen in patient selection and risk stratification, right? This is one that shows suitable, questionable, go inpatient, right in that suitable again goes to that performance status of that patient. How far away do they live? And are there any issues already with a neurologic disease? Then, the patient you would want to think about a little more cautiously, or maybe an elderly patient. With comorbidities, though, that does not rule you out from having bispecifics.  

Do you have limited caregiver ability? That's why we've had to do some of ours inpatient; they just don't have that support, and they can't get back and forth. Then think about, even though they're remote, do they have the ability for robust telemonitoring? This is where some of those telemonitoring devices and things like that can really come into play. You look at what Mountain West has done, for instance, in their center with their community partners, really helping them set up to give bispecifics out in the community. They have a great program if you're not familiar with it. Then, who needs to go inpatient? This is your patient who you're worried is more unstable. They already have maybe an active infection. Now I wouldn't typically start knowing they have an active infection, but it's worth mentioning if you're suspicious there.  

Beth Faiman: Sometimes, if it's off the shelf and their disease is progressing, you have no choice.  

Charise Gleason: We've got those balances that we walk, right? We've those where you have to pull that and go when it's not always ideal. Then, are there cognitive barriers to that? And then again, so starting then with your dosing, how does that post step up dosing look? These are different options. Once the disease is stable, do you go two cycles and then start deescalating down on your frequency? I think you've heard us both say that we get to every 4 weeks as soon as possible, but there are different ways to do this. The labeling sometimes says something different than what we do in practice. But going from weekly to every 2 weeks is an option, going every two weeks to every four weeks. And I can tell you we're already pushing doses out every eight weeks. Now, we've got patients on every 12 weeks.  

Those are patients whose disease is totally in control; they're in remission. So, the complete response rate, and we're not having issues with CRS dosing at that level. So, it keeps the patient on and minimizes those side effects. And so all things to look at. Then, I'm going to end by showing some of Mount Sinai Donna's data on a hybrid model. So, quality improvement project, and I hope I do it justice here, Donna. So I think I mentioned earlier, atezolizumab has a really long half-life, 2 weeks. They looked at it and said that subsequent CRS is less likely during that window. So they have a hybrid dosing schema that they give on the inpatient side. If the patient has CRS and gets toci and no further issues, they get discharged. I'll show you that on the next slide. But again, if there's no caregiver, if there's significant comorbidities or the primary physician thinks that it's better suited inpatient, right, that risk stratification's in place, that patient would go inpatient.  

Here's what it looks like. This was the talquetamab experience. So you can see it after step-up dose day 1, if they had that CRS got toci and no further symptoms, they're discharged home and then monitored, and the same after day 3. So, if they've not been discharged by step-up dose 3, then they stay, and they're staying in the hospital at that point. Then, when they are discharged, they are discharged with dexamethasone and Levaquin as needed. What I like about this is that it shows you the handoff plan in any center, wherever you are in the community, in an academic center, you need good handoff discussions among the team, and the patients to know what they need to look out for. So, Mount Sinai is giving the patients a thermometer and a logbook to document their temperatures. They get dexamethasone and Levaquin. The physician reaches out to you, and you can see all the team members to make sure they understand the on-call APP or that the physician understands that this patient has been discharged. It seems like a good system, actually.  

Donna Catamero: We'll add, we added a hotline. If the patient is having symptoms in the middle of the night, they have a dedicated number to call with a dedicated person, physician to answer.  

Charise Gleason: So I'm thinking, you kind of agree with me… 

Donna Catamero: I don't know, but maybe I do, maybe I don't. So I've said this before, too. The immunosuppression timeline we can see at any point, but that first month onwards is when we really start seeing immunosuppression. This is where I think is where it becomes extremely challenging. So it's the logistics, the operations of doing something outpatient, and staffing, especially in the community. They might see five myeloma patients a year. Why not just admit them? Because of the staffing, where are they going? The emergency department, which we learned the hard way, has a high turnaround. So you could be educating the ED staff, but then three months later, it might be new staff. And this is where I wanted to tell you my ED story. This was a CAR T patient, so not a bispecific patient, but someone did have CRS. Of course, after hours, the patient was instructed to go to the ED, and the proper communication and handoff were done.  

We handed it off, reported it to the ED, and instructed the ED to give toci. The patient showed up to the ED 13 hours later but still had not received toci. You can have everything in place, from your EPIC flags to your alerts to the orders, and things still happen. I think staffing education, the knowledge gap there continues the infrastructure. We have to admit we don't have an oncology emergency, and we're a big academic center, but we don't have that pathway to get a patient right to a bed. I think most centers in the community also are probably going to be under that same constraint, where they don't have the logistically, they can't get a patient right to a bed, or they have to go through the ED, and then does that staff know what to do when they have a patient who is presenting with CRS?  

These are things to consider when we're trying to do something. And I believe in equity of care, and I believe that these should be given out in the community, but there are still operations and logistics that I think are hard to overcome. So, the Stop/Switch algorithm, looking at the quality of life and when to whole dose, I went through this with the burden of some of these toxicities, but when do I give up and stop and switch to another agent? We know that these drugs are very effective, and I think proper management of patients can stay on these therapies for a long time. I have patients 7 years on bispecifics that started on clinical trials and are still doing extremely well. And like you said, maybe we're dosing every three months and they're still in a stringent CR. I think these are highly effective in knowing when to hold and when to deescalate administration of these drugs. I think we still need to learn how to give these drugs, and then hopefully we can get these more out into the community where we feel more comfortable. Patient management.