Multidisciplinary Training of BiTE-Associated AEs Increases Safety in Outpatient Setting

Administration of bispecific T-cell engager (BiTE) therapies in both inpatient and outpatient settings may be more successful following the implementation of both patient and health care education methods regarding associated toxicities, as well as enhanced multidisciplinary patient monitoring strategies, according to findings from a study conducted through New York University Langone Health’s Perlmutter Cancer Center.¹

In a poster presented at the 50th Annual Oncology Nursing Society Congress, study authors noted that BiTEs have expanded the treatment paradigms for several types of solid tumors and hematologic malignancies. However, toxicities associated with this class of agents—predominantly cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS)—have raised safety concerns about the use of these agents and prompted the need to create a safer environment for patients receiving these drugs. For instance, epcoritamab-bysp (Epkinly), the newest BiTE therapy to enter clinical practice, was FDA approved in June 2024 for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least 2 prior lines of systemic therapy.² In the pivotal EPCORE NHL-1 trial (Study GCT3013-01; NCT03625037), the rates of CRS and ICANS among patients who received epcoritamab (CRS, n= 86; ICANS, n = 127) were 49% (grade 1, 45%; grade 2, 9%) and 6.0%, respectively.The prescribing information for this agent includes a Boxed Warning for serious or fatal CRS and ICANS.

Providing Education About BiTE-Associated AEs

A multidisciplinary team from Perlmutter Cancer Center consisting of physicians, advanced practice providers, pharmacists, and nurses reviewed recently published literature on symptom management in patients receiving BiTE therapies to outline the optimal management of BiTE-related CRS and ICANS.¹ From there, the study investigators created a cross-campus workflow to help patients and health care providers properly identify these toxicities and educate health care providers about symptom management.

The poster authors noted that educating health care providers and patients about patient safety when receiving BiTEs was crucial for the success of this program. Accordingly, health care professionals across the Perlmutter Cancer Center were educated about the adverse effects (AEs) and toxicities associated with BiTEs. Patients were educated about the AEs they may experience while receiving these therapies, as well as what toxicity-related information to report to their health care providers.

“Timely intervention and coordinated follow-up visits with the oncology care team are crucial for optimal outcomes,” the authors noted in the study abstract. “However, in the event of an acute illness, the medical attention sought may come from an emergency department (ED) where the practitioners may not be as knowledgeable in the management and/or recognition of these specific toxicities.”

Improving Multidisciplinary AE Management

To improve the management of BiTE-associated toxicities in the ED, patients received wallet cards containing BiTE-specific symptoms to be aware of and were instructed to present to any health care provider outside of their oncology team. Additionally, the study authors developed educational resources regarding the optimal methods for monitoring and managing AEs in patients receiving BiTEs; these resources were disseminated to health care providers working in the ED or inpatient settings. These cards and educational opportunities facilitated a safe environment for outpatient BiTE administration.

Furthermore, a system was implemented to trigger an alert in the electronic health record (EHR) of each patient receiving BiTE therapy whenever they presented to the ED to allow for quicker CRS- and ICANS-related symptom assessment and intervention. The study investigators noted that although a variety of assessment instruments exist to determine patients’ neurological status, the instruments chosen for this multidisciplinary process were not available in the EHR. Therefore, the research team collaborated with an Information Technology team to improve the ease of access to the chosen neurological toxicity scales. This included a flowsheet created by the Technology team with the respective information that was available through the EHR.

“The collaboration between disciplines and the education developed has been integral in ensuring high comfort levels with these newer BiTE therapies,” the poster authors explained.

Since the implementation of this study’s methods, several patients have received BiTE therapy administration in Perlmutter Cancer Center outpatient infusion centers. BiTEs administered in this setting include teclistamab-cqyv (Tecvayli; n = 326 treatments), talquetamab-tgvs (Talvey; n = 49), epcoritamab (n = 48), tarlatamab-dlle (Imdelltra; n = 39), and mosunetuzumab-axgb (Lunsumio; n = 9).

“Although not a new classification of medicine, BiTE therapies are exploding on the marketplace where historically there has only been 1. Education, communication, and workflows are crucial to safely and successfully treat these patients,” the authors concluded.

References

1. Braun S, Wigger K, Pasqua D, Mendez S. An interdisciplinary, cross campus approach to create a process for the safe administration of bi-specific T-cell engager therapy. Presented at: 50th Annual Oncology Nursing Society Congress; April 9-13, 2025; Denver, Colorado. Abstract P73.
2. FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma. FDA. June 26, 2024. Accessed April 10, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-epcoritamab-bysp-relapsed-or-refractory-follicular-lymphoma