Navigating the Rapid Expansion of Cellular Therapies: Challenges and Opportunities for Community and Academic Collaboration

Cellular therapies are rapidly expanding not only in terms of newly approved agents, but also approved indications, explained Sarah Rockwell, PharmD, BCOP, a clinical oncology pharmacist, malignant hematology, Florida Cancer Specialists & Research Institute, during a panel discussion at the 2024 Advanced Topics for Oncology Pharmacy Professionals (ATOPP) Summit in St Louis, Missouri. To date, much of these approvals have been in malignant hematology indications.

“A lot of us who have been working in cellular therapies have a lot of background in malignant hematology because that's where these agents have really gained a lot of traction. So solid tumor specialists are probably feeling left out—but fear no more because tarlatamab [Imdelltra; Amgen] was FDA approved [on May 16] with the DLL3-directed bispecific antibody in small cell lung cancer—so very exciting,” Rockwell said during the ATOPP session. “If you've been able to avoid them thus far because you're more in the solid tumor space—it's coming, and it's coming fast. It's a very exciting time.”

However, session panelist Zahra Mahmoudjafari, PharmD, MBA, BCOP, FHOPA, clinical pharmacy manager in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Health System University of Kansas Health System, noted that the FDA approvals in cellular therapeutics have been coming so quickly that implementation of these therapies following institution-wide standards of practice (SOPs) can be a challenge.

“We are flying this airplane while we're building it, and it is made of popsicle sticks,” Mahmoudjafari said. “It's turbulent, we don't have windows, and we don’t have a pilot. So we're really working on putting this together, and we have to make sure that we ensure appropriate access to our community settings.”

One of the challenges facing community settings when adopting cellular therapies is the management of the adverse effect (AE) profiles of these therapies, according to Rockwell. In practices that have been using cellular therapies for some time, pharmacists have become more adept at managing cellular therapies’ unique AE profiles. But in the community setting where adoption is less common, this will be more difficult.

In practices that have been using cellular therapies for some time, pharmacists have become more adept at managing cellular therapies’ unique AE profiles. Image Credit: © HijabZohra - stock.adobe.com

“It's really a new era of [AEs]. For those of us who have been seeing these agents in clinical trials, maybe it's not so much of a new era for us, because we've been dealing with cytokine release syndrome [CRS] and immune effector cell-associated neurotoxicity syndrome [ICANS] for a while, but these community providers have not been because they haven't been doing these clinical trials necessarily,” Rockwell said. “That's another reason why we really need to increase education, awareness, and access to these drugs.”

Because of their AE profiles, many of these cellular therapies also have associated Risk Evaluation and Mitigation Strategies (REMS) programs as well, which require significant coordination and operational considerations, according to Rockwell.

“One thing that we really have to think about, especially in the community setting, is the infection risk, which may be significantly higher and more prolonged in these patients who have received cellular therapies or bispecific antibodies, because many of these patients, especially [patients with] multiple myeloma, for example, are heavily pretreated and are receiving a lot of these therapies indefinitely,” Rockwell said. “[This is] something that we need to increase awareness about and education about as we [implement] these products.”

Further, Rockwell noted that it may not always be up to a community center provider as to whether they will start a patient on a cellular therapy or not, as often this decision is being made by a provider in an academic medical center first, and then the patient is being moved to the community setting. This may also mean that community providers may not be selecting which therapy the patient is being started on, forcing them to adapt to therapies that have been pre-selected by other providers based on their institution’s SOPs.

“Because we're in the community center setting, and we are accepting patients after they've already started therapy at an academic medical center…we're not really the ones making the decision on what to start the patient on,” Rockwell said. “For us, it really comes down to access. We don't have specialists in the community setting, as our providers are seeing a wide variety of patients. So where are we hearing that there's a need? Providers from Moffitt Cancer Center [may be] reaching out saying, ‘Can you treat our patient with teclistamab [Tecvayli; Janssen Biotech, Inc]?’”

In this way, community centers may be somewhat forced to begin implementing cellular therapies before they are entirely ready to do so, according to Rockwell. When this occurs, it can be highly beneficial if 2 cellular therapies are similar in terms of implementation, Rockwell explained.

“It was very attractive that teclistamab and elranatamab [Elrexfio; Pfizer], for example, were clinically and operationally very similar, because that meant, as a new program just starting to establish [ourselves] and get our feet wet [in the cellular therapy space], it really wasn't going to be that intimidating to add on another drug that was very similar,” Rockwell said. “All that was really going to do was improve access for patients who got started on another drug at another center.”

Additionally, for providers in the community setting, they may only be treating a patient with a cellular therapy every 1 to 2 months, which can make managing the unique toxicities of cellular therapies an ongoing area of difficulty, Rockwell explained.

“It can be a little bit intimidating for these community providers who aren't seeing this every day. They may be getting 1 patient a month or 1 patient every 2 months, so do we want to introduce CRS, ICANS, and all of talquetamab’s [Talvey; Janssen Biotech, Inc] new toxicities at the same time? Maybe let's get them comfortable with bispecifics and those early toxicities that we worry about with the REMS program,” Rockwell said. “Once they feel comfortable tackling that, then let's add in another drug that [requires] focus on some of its unique nuances.”

Ultimately, Rockwell explained that improving access to cellular therapies for patients in the community setting is the goal. However, finding an efficient way of implementing these complex therapies remains challenging.

According to panelist Mylove Mortel, MSPH, RN, OCN, director, transplant, cellular therapy and advanced hematology of the University of Chicago Medicine, her academic medical center has algorithms for clinical pathways and SOPs that help standardize some of the complex decisions around which cellular product is selected for each patient. However, even for her large center, the fast pace of approvals for new indications means the algorithms and SOPs need to be written broadly to allow for fast-paced changes to be made.

“They're generally written broadly to apply to multiple indications because there will be yet another new indication soon, so our SOPs are specifically designed to be broadly applied,” Mortel said. “If there's a specific toxicity or something that we have to keep in mind for a particular product, then we do [put that] into the SOP, but because we're trying to make sure that it's [implemented in] a standardized manner, we have to write them broadly.”

According to Rockwell, the development of collaborations and partnerships between academic medical center and community centers will be important to ensure access to cellular therapies continues and develops across the country.

“My word of the day is access,” Rockwell said. “I'm so happy to see collaborations forming [between community centers and] academic medical centers. I just I want to see more of those collaborations. And I want to see our pharma partners helping foster those collaborations because you all are the ones who know who's prescribing it and where they're looking for patient pockets in the community.”

REFERENCE

Rockwell S, Mahmoudjafari Z, Mortel M. General Session: Unleashing the Next Generation of Cellular Therapies: Where Have We Been, Where Are We Going, and How Do We Get Treatment Access to Communities? 2024 ATOPP Summit; St Louis, Missouri; June 27-29, 2024.