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Since 2022, the introduction of 6 additional T cell–engaging bispecific antibodies has transformed the therapeutic landscape across several oncologic, hematologic, and ophthalmologic indications. These approvals catalyzed a need for institutions to develop operational processes that would ensure safe and effective delivery of these novel therapeutics.
In 2014, blinatumomab became the first bispecific T-cell engager (BiTE) approved by the FDA to treat B-cell acute lymphoblastic leukemia. At the time of this approval, use of this BiTE required administration via continuous infusion and, as such, necessitated hospital admission. Additionally, many clinicians were more comfortable delivering the novel therapeutic in an inpatient setting due to its relatively unfamiliar toxicity profile. More recently (and especially since 2022), the introduction of 6 additional T cell–engaging bispecific antibodies has transformed the therapeutic landscape across several oncologic, hematologic, and ophthalmologic indications. These approvals catalyzed a need for institutions to develop operational processes that would ensure safe and effective delivery of these novel therapeutics, which were individually associated with varying recommendations and routes of administration.
In early 2023, St. Luke’s Cancer Institute in Boise, Idaho, recognized the importance of operationalizing these T cell–engaging bispecific antibodies, particularly since the majority of the approved agents target hematologic malignancies. A multidisciplinary team comprising health care providers, nursing staff, and pharmacists at the facility was gathered to develop comprehensive policies and procedures for bispecific antibody administration. The team worked together to address the following:
A unique component of this initiative was the development of an outpatient monitoring system. Patients were provided with equipment to measure vital signs at home (eg, blood pressure cuffs, pulse oximeters, and thermometers). Patient wallet cards and educational booklets outlining events to expect, signs and symptoms to recognize, and ways to record important clinical information in the home setting were distributed to patients. Importantly, nursing staff conducted educational classes for patients and caregivers prior to treatment initiation. These classes ensured that patients and their caregivers understood how to monitor their health for signs and symptoms of cytokine release syndrome (CRS) or immune effector cell–associated neurotoxicity (ICANS), when and whom to call in case of issues, and how to use the monitoring devices correctly.
On the day of treatment initiation, the patient receives bispecific antibody therapy in the morning and is contacted at home by a St. Luke's triage nurse later in the day. The patient is seen in-person by a provider the next morning and then receives 3 additional phone calls from a nurse over the next 2 days. During each call, the nurse walks the patient and caregiver through the vital sign monitoring process and screens for any signs of neurotoxicity. This routine is repeated with each step-up dose, and guidance is provided throughout. The structure of this process provides confidence for the clinician that the patient is being closely monitored for signs of toxicity and enables the patient to receive treatment while spending most of their time in the comfort of their home.
In the event of a concerning symptom such as fever, the patient contacts the on-call provider, who guides them through potential outpatient management using acetaminophen or dexamethasone. If the fever does not resolve in a timely manner, the patient should be hospitalized, as steroid-refractory CRS is considered a grade 2 toxicity. The ability to manage some grade 1 toxicities in the outpatient setting is truly unique, and it has the potential to safely expand patient access to bispecific antibody therapy in accordance with CRS/ICANS guidelines.
To satisfy regulatory requirements, particularly for risk evaluation and mitigation strategies (REMS) programs, documentation is critical. All providers must be appropriately registered and adequately prepared for an audit. The operational champion of an institution’s bispecific antibody program (often, the lead pharmacist) should serve as the authorized representative and set up all necessary delegations within the health system. Maintaining comprehensive records of provider training and dispensing activities is vital for sufficient regulatory compliance and audit readiness.
Since the implementation of the bispecific antibody program at St. Luke's, approximately 30 patients have received one of the novel therapeutic agents. In all, 10-12 patients have successfully undergone bispecific antibody treatment fully in the outpatient setting. The success of the program at St. Luke's serves as proof of concept demonstrating that this therapeutic class can be administered safely in the outpatient setting with the appropriate clinical algorithms, structured follow-up, and infrastructure in place.
As the bone marrow transplant/rheumatologic malignancy pharmacy program coordinator, Robert Mancini, PharmD, BCOP, FHOPA, is enthusiastic about sharing his program’s success, and he has helped to operationalize similar programs at smaller community cancer centers and larger academic centers alike. He is available to answer questions; please contact him at mancinir@slhs.org.
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