Oncology Data Advisor: Hi, and welcome to Oncology Data Advisor. Today I'm speaking with Beth Faiman about her recent presentation at the International Myeloma Society Annual Meeting. Dr. Faiman, thank you so much for being here with us today.

Beth Faiman, PhD, CNP: Hello, my name is Beth Faiman. I am a Nurse Practitioner and a researcher at the Cleveland Clinic in Cleveland, Ohio. I've been at the Cleveland Clinic since 1994, and I've been fortunate to be working with plasma cell and blood disorders ever since then. Currently, I am working on a scoring system for cellular therapy candidates, and I think that's what we're going to be talking about today.

Oncology Data Advisor: Yes, I'm excited to hear more about your presentation. Just by way of background, what are some of the challenges that are involved when selecting patients for treatment with CAR T-cell therapy?

Dr. Faiman: Right, so CAR T-cell therapy has been FDA-approved in the United States for multiple myeloma in patients with relapsed and refractory status since 2021. There are now two products approved. There is idecabtagene vicleucel (Abecma^®) from 2021 and ciltacabtagene autoleucel (Carvykti^TM) in 2022. These are valuable therapies for the patients who oftentimes have limited options, but unfortunately, there's a lack of supply right now. They're in such high demand, and it's really hard to get on the list and be selected for one of these therapies when few options are available.

Oncology Data Advisor: Tell me a little about your study; how did you go about developing this scoring system?

Dr. Faiman: I work in a large group practice at the Cleveland Clinic. I have numerous researchers that I partner with, and we have these meetings that are convened on a weekly basis. It's composed of physicians, nurses, nurse practitioners, and other support staff. In these meetings on a weekly basis, we're trying to determine who would be the best next candidate when you have one slot or two slots from that company, and a list of 40, 50, or sometimes 80 patients who would be candidates.

We had these early discussions and they said, "You know, it would be really great to be able to categorize or rank order to determine the best way of selecting, so those patients don't miss out on the opportunity, the ones that really need it." We developed this six-criteria scoring system, and we developed a maximum criteria number of 18. Those that qualify have the worst disease, what we call penta-refractory disease, or they've had a recent aggressive relapse with lots of tumors. Maybe they're requiring bridge therapy with some very sophisticated inpatient chemotherapy. Others are not in remission, but we do want them, over and above anything else, to be clinically stable in order to harvest these cells and send them off for manufacturing. Then they come back to the patient four to eight weeks later.

Again, through discussions with the clinical team, we've devised this system through expert opinion and literature review. There's really nothing like this out there at any of the large myeloma institutions in the country, from what I understand.

Oncology Data Advisor: That's really exciting. What are the criteria and the factors that this scoring system involves?

Dr. Faiman: Just as I previously mentioned, we're really looking at those who don't have any other options. When people are considered penta-refractory—and these are the ones who are the best candidates—they have failed a drug called an anti-CD38 monoclonal antibody. They've also failed proteasome inhibitors and immunomodulatory drugs, the backbones of our treatment. Also, they've had exportin 1 (XPO1) inhibitors such as selinexor or other B-cell maturation antigen (BCMA) therapies off the shelf, such as belantamab mafodotin. Those are the five drug classes that all of our patients will oftentimes be exposed to.

We also want them to be fit enough so that they can tolerate this therapy. There is a long process in this selection of patients. Of course, according to the FDA guidance, they have to be willing and capable and able to have support systems such as caregivers support, as well.

Oncology Data Advisor: Great. Now that this has been developed, what are the next steps for it, and how can it be implemented into practice in the future?

Dr. Faiman: Unfortunately, we are still in our infancy. The tool development is a lengthy process, and I'm trying to work with my researcher colleagues to expedite this. Others have reached out to me to validate this tool, and when you're developing a clinical tool, you want it to be reproducible. You want to make sure that whoever implements or uses this tool in their practice will have similar results to the Cleveland Clinic at their institutions. There's a validity and reliability of this tool that still needs to be investigated. We need to try this out on more patients, and we are continuing to do so.

My abstract only reported data from February to May of 2022, but we're continuing to score our patients on a weekly basis at Cleveland Clinic. Hopefully, we'll be able to open up this tool for use in other institutions as well, so that we can make this generalizable and so that others can benefit from it as well.

Oncology Data Advisor: That's great. Is there anything else you'd like to share about this research?