Teclistamab: OPTEC Trial Overview
Panelists discuss how the OPTEC trial and other studies demonstrate that outpatient teclistamab administration with prophylactic tocilizumab is feasible and safe, with no cytokine release syndrome (CRS) events reported in community settings, while acknowledging that Risk Evaluation and Mitigation Strategies (REMS) requirements remain a significant barrier to broader community adoption despite the reality that most CRS is now grade 1-2 and manageable with supportive care, suggesting the field needs to follow lymphoma’s example of bispecifics without REMS restrictions.
Teclistamab OPTEC Trial Overview
The OPTEC study evaluated community-based administration of teclistamab with prophylactic tocilizumab across 12 different sites, enrolling 13 patients in a prospective outpatient protocol. The dosing schedule involved accelerated step-up timing with doses given on day 1, followed by the next dose within 0 to 4 days, and the subsequent dose within 1 week. Remarkably, no patients experienced CRS with this prophylactic approach, and no hospitalizations were required during the step-up period. Only 1 patient could not complete the regimen due to progressive disease rather than treatment-related toxicity, demonstrating the feasibility and safety of this approach in community settings.
A second study examined 20 patients who received prophylactic tocilizumab with traditional dosing schedules, maintaining the standard day 1, day 3, and day 5 approach similar to the MajesTEC-1 trial. This population had characteristics similar to the registration trial, with a median age of 72 years and 70% meeting MajesTEC-1 study criteria. Patients received premedications including acetaminophen and antihistamines and were required to remain within 60 minutes of the hospital with access to 24-hour caregivers. These studies collectively demonstrate that prophylactic tocilizumab can effectively mitigate CRS risk and enable safe outpatient administration.
The discussion highlighted important implementation barriers, particularly the REMS requirements that create reluctance among community oncologists. The panelists noted that current CRS events are predominantly grade 1 or 2, manageable with supportive care measures like acetaminophen, which differs significantly from early experiences with higher-grade toxicities. They drew comparisons to lymphoma bispecifics that have gained approval without REMS restrictions, suggesting this represents a critical barrier to broader adoption. The consensus was that REMS should not deter bispecific use, as the current safety profile is comparable to other standard therapies like daratumumab. Future bispecific approvals, particularly in solid tumors, may help establish precedent for REMS-free approvals in hematologic malignancies.
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