Bispecifics in Multiple Myeloma: Insights on Operational Readiness and Patient Care

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Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, addresses some of the considerations for bispecifics in relation to facility readiness at different sites and among different stakeholders.

Pharmacy Times interviewed Kirollos Hanna, PharmD, BCPS, BCOP, FACCC, on his presentation at the Hematology/Oncology Pharmacy Association (HOPA) Annual Conference 2024 in Tampa, Florida titled “Key Considerations for Operationalizing Bispecifics in Relapsed or Refractory Multiple Myeloma.” Hanna discusses some of the specific considerations for bispecifics in relation to facility readiness, and the role of the pharmacist in operationalizing bispecifics at their facilities.

Pharmacy Times: Teclistamab-cqyv was approved by the FDA in 2022 for the treatment of relapsed or refractory multiple myeloma. Is this the only bispecific currently being used to treat this disease state, or are other bispecifics being used as well?

Image Credit: © luchschenF - stock.adobe.com

Image Credit: © luchschenF - stock.adobe.com

Kirollos Hanna, PharmD, BCPS, BCOP, FACCC: When we look at the myeloma space, the BiTE [bispecific T-cell engager] era has really expanded significantly since 2022. So when you look at teclistamab-cqyv [Tecvayli; Janssen Biotech, Inc], it was the first bispecific therapy in myeloma, and it is a BCMA-targeted therapy. Now, while BCMA is not a new mechanism within myeloma, we've had ADCs [antibody drug conjugates] and other therapeutics targeted, [but] teclistamab-cqyv was the first to market. Then you also look now and where we are with myeloma, we have talquetamab [Talvey; Janssen Biotech, Inc], which targets GPRC5D. Then we also have elranatamab [Elrexfio; Pfizer], which is another bispecific within this space. So, we have 3 exciting opportunities that we can utilize for different therapeutics for patients. And when you look at the current approval for these drugs, across the board, they are in a penta refractory patient population, so 4 lines in. There is a lot of ongoing research within this space, and it's likely that we're even going to see these therapeutics move into earlier lines of myeloma. There are a lot of things we have to operationalize for our patients as well, but it's very, very exciting.

To show you the impact that these bispecifics have had on myeloma patients, back in 2015 or 2016, we had daratumumab (Darzalex; Janssen Biotech, Inc) approved in myeloma, this was the first CD38 monoclonal antibody approved. And since daratumumab, in this penta refractory patient population, we have not seen degrees of complete responses and overall responses anywhere remotely as close as what we saw back in the daratumumab days. So you look at teclistamab-cqyv, for example, and you look at the MajesTEC-1 trial [NCT04557098], and I mean, the overall response rate is about 60% to 70%. But then even when you look at the degree of patients who have a very good partial response or better, or a CR or better, it is a significant group of patients that ultimately will benefit from therapy and will have a long durable response. Given that it's a penta refractory patient population, these therapies are really exciting. It's going to be interesting to see in the next coming years, how these change the paradigm of myeloma.

Pharmacy Times: What are some of the specific considerations for bispecifics in relation to facility readiness, and 2 years after the FDA approval of teclistamab-cqyv and 10 years after the approval of blinatumomab, are there still challenges in this area?

Hanna: So bispecifics facility reading readiness is very, very important. While we've had bispecifics in the market for quite some time going back to the blinatumomab days, we now have, like I mentioned, 3 in myeloma, we have bispecifics in uveal melanoma, and we have a lot of ongoing bispecifics that have PDUFA dates this year, and then a lot of clinical trials that continue to look at different targets of bispecific. So, when you talk about facility readiness, it's critical that facilities develop some type of processes for them to be able to administer bispecific therapeutics, because this space is up and coming. And we're going to see quite a few therapeutics in the next coming months and years.

So, what are some of those things around facility readiness? You're going to have to look at the facility infrastructure. Are you an academic institution? Do you have a hospital-affiliated with your system? Are you a community practice? And if you are a community practice, what does that look like? What are relationships that you have with local hospitals or local emergency rooms, because when you look at some of these bispecifics, some may have a REMS [risk evaluation and mitigation strategy] program, some may not have a REMS program, but really across all of the bispecifics, cytokine release syndrome, ICANS [immune effector cell-associated neurotoxicity syndrome], neurotoxicity, infections—these are all shared adverse events between these therapeutics, and facility readiness is very, very important to ensure that we can ramp up patients safely. [Also, that] we have the proper supportive care measures in place, we have the adequate staff that's trained and familiar with some of these adverse events and the management of these adverse events, and, again, developing these relationships with other systems.

I work currently for community oncology, and a hot topic within the community is how do we operationalize bispecifics when things like the package insert of these products and then the prescribed labeling says patients should be hospitalized. People don't really know how to operationalize that, especially if they're not affiliated with a hospital. So, there's some worry and some concern, for example, around ramping up patients, because also when you look at some of those adverse events like the CRS, ICANS, and neurotoxicity is the highest incidence, where you might see this is when that patient is being ramped up when they're first exposed to therapy. So those operational considerations are very important, so developing things like SOPs, relationships with hospitals that you can refer to and you can get your patients refer back based on the resources and the infrastructure available, but it is inevitable that practices will need to develop this out.

Now, the exciting thing is that while we're limited in terms of direction of what the prescribed labeling may provide, you look at, for example, Emory put out a publication about 2 to 3 weeks ago around prophylactic tocilizumab [Actemra; Genentech, Inc] administration prior to bispecific therapy. And when you look at the incidence of how they were able to reduce the incidence of CRS, it was very significant in the tocilizumab prophylaxis patients. There are ongoing groups that are going to be publishing around safe outpatient administration. Going back to my daratumumab example, which I highlighted, back in 2015-16 when daratumumab was first approved, it was this monoclonal antibody in a penta refractory population with significant concerns around infusion reactions or infusion-related reactions. [There were] very long infusion time and health care systems did not know how to best operationalize that. You look at daratumumab today, we have subcutaneous, we have rapid infusion, we can eliminate pre-medications, and this is exactly what's going on with bispecific era. We have adverse events that we're going to continue to learn how we can manage or prevent. And then we're ultimately going to start seeing protocols that help in the event that those adverse events do manifest that you have outpatient support for these patients. And in small steps that you might require hospitalization and such. But again, that facility readiness, your HCPs [health care professionals], your sites, every stakeholder that would touch that patient does need to have some type of familiarity with bispecifics.

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