Nurse Practitioner Mount Sinai Hospital Jersey City, New Jersey, United States
Introduction: Cytokine release syndrome (CRS) is a systemic inflammatory response commonly associated with T-cell engagers. Teclistamab is the first B-cell maturation antigen bispecific antibody approved for the treatment of relapsed/refractory multiple myeloma (RRMM). In the MajesTEC-1 study, 72.1% of patients experienced CRS; most events were grade 1 (50.3%) but 21.2% were grade 2 and one grade 3. The CRS management guidelines recommended tocilizumab use for grade 2 events but could be considered in certain grade 1. CRS was managed with tocilizumab (36.4%), steroids (8.5%), supplemental oxygen (12.7%), and vasopressors (0.6%) (Moreau et al, NEJM, 2022). Here, we aim to describe the real world experience (RWE), which historically includes patients who would not have been eligible for clinical trials, using a more proactive teclistamab use to manage CRS.
Methods: This retrospective study analyzed data from RRMM patients who were treated with commercial teclistamab at our center as of December 1, 2022. Patients were identified using the pharmacy’s database and data was abstracted from electronic medical records. Information on treatment administration, disease profile, toxicities including CRS and management were collected. Per institutional policy, the use of tocilizumab was used at first onset of fever during the initial step-up doses of teclistamab.
Results: As of May 30, 2023, 35 patients were treated. Data from 26 patients has been analyzed and data from all patients will be presented at the meeting. Overall, 78% of patients experienced any grade CRS. Among patients with CRS, 85% of patients experienced a grade 1 CRS and 15% had a grade 2. There were no grade 3 events. Seventy percent of CRS events occurred with step-up dose (SUD) 1, 35% with SUD2 and 20% with cycle 1 day 1. Two patients had CRS after cycle 1 day 1. Of these two, one had plasma cell leukemia and the other significant extramedullary disease. All patients presented with fever (38.5C) and were administered tocilizumab and acetaminophen with first at first occurrence. Other supportive measures included steroids (25%) and intravenous fluids (5%). Four patients had subsequent CRS after initial dose of tocilizumab; all events were grade 1.
Conclusions: Our RWE is comparable to the MajesTEC-1 in terms of overall CRS incidence, despite a patient population which would not have been eligible for clinical. We expected this population to be more vulnerable to higher grades of CRS yet data showed a more benign course. We attribute this to aggressively managing CRS with use of tocilizumab and acetaminophen at first sign of CRS to prevent further escalation. CRS episodes were seen less in subsequent teclistamab doses and severity was never above grade 1, making it more manageable in a potential outpatient setting. A proactive management approach to reduce severity and increase predictability could facilitate adoption of outpatient when treatment and escalation are needed, to ensure successful administration of teclistamab.
