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    Cellular and T cell engager Immunotherapy

    Category: Cellular and T cell engager Immunotherapy

    Real world accelerated step-up dosing of Teclistamab and Talquetamab in the outpatient setting is feasible and associated with low incidence of cytokine release syndrome.

    (PA-037) Real World Accelerated Step-up Dosing of Teclistamab and Talquetamab in the Outpatient Setting Is Feasible and Associated with Low Incidence of Cytokine Release Syndrome

    Friday, September 19, 2025

    Introduction:      Teclistamab (Tec) and Talquetamab (Talq) are T-cell redirecting bispecific antibodies (BsAb) for the treatment of relapsed-refractory multiple myeloma (RRMM). We instituted an accelerated step-up dosing (aSUD) schedule in the outpatient setting as described in the FDA prescribing information, wherein BsAb are given every 48 hours if no evidence of cytokine release syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS). This is the first study to describe the outcomes of an aSUD BsAb regimen as an outpatient (OP).

    Methods:   We conducted a retrospective cohort study of patients with RRMM who received Tec or Talq under this protocol from May 1, 2024, to May 30, 2025. Salient exclusion criteria included bone marrow involvement >60% and ECOG >2. BsAb were administered every 48 hours if there was no CRS or ICANS with daily evaluation in the OP clinic. Patients were educated to take acetaminophen and dexamethasone (dex) for fever without any other co-morbid symptoms, and were admitted if fever did not resolve after 1-4 hours. The primary endpoint is the incidence of CRS and ICANS. The secondary endpoint is the incidence of hospitalization.

    Results:   A total of 30 patients started OP aSUD; 15 patients received ≥1 Tec dose and 15 patients received ≥1 Talq dose. Median age was 68.5 yrs (35-89). Patients received a median of 4 prior lines of therapy, 8 patients (26.7%) had prior CAR T-cell therapy, and 5 patients (16.7%) previously received another BsAb (Tec). Eleven patients (36.7%) developed CRS (Gr 1 n=10, Gr 2 n=1) and none developed any grade ICANS.  Seven patients (23.3%) developed CRS following SUD1, 6 (20%) following SUD2, 3 (10%) following SUD3 (Talq), and 1 (3.3%) following SUD4 (Talq). Among the 11 patients with CRS, 5 patients were completely managed OP. Four patients (13.3%) were admitted for CRS while 2 patients developed CRS during hospitalization for tumor lysis and suspected infection, respectively. Five patients (16.7%) received tocilizumab for CRS treatment. Ten admissions were prevented with OP management of CRS with acetaminophen/dex out of 17 individual CRS events.

    Conclusions:   To our knowledge, this is the first real-world report describing an aSUD protocol for Tec and Talq in the outpatient setting. The low CRS rates in this study are comparable to those previously published by Puttkamer and colleagues who utilized a standard step-up schedule OP model. The low incidence of CRS without neurologic toxicity suggests that an OP aSUD with daily monitoring and escalation of care for toxicity management is safe and reduces health care resource utilization. Including tocilizumab prophylaxis prior to SUD1 may further reduce the risk of CRS and could enable a completely outpatient delivery without the need for intense monitoring.