Improving Access and Safety: Implementation of a Standardized Protocol for Bispecific Antibody Therapy in a Northern Ontario Regional Cancer Program ^†

Introduction:

The introduction of T-cell engaging therapies has revolutionized the treatment of R/R Multiple Myeloma (MM), B-cell Non-Hodgkin Lymphoma (B-NHL), and Small Cell Lung Cancer (SCLC). However, the risk of CRS and ICANS often limits these therapies to large academic centers. For patients in Northern Ontario, travel to tertiary centers is a significant barrier. Our Quality Improvement (QI) project sought to implement a safe, regional delivery model that minimizes inpatient burden while maintaining high safety standards.

Methods (The PDSA Cycles):

• Plan: We established a multidisciplinary team (Oncology, Pharmacy, Inpatient Hospitalists) to create standardized order sets.
• Do: We treated 27 patients across four cancer types.
• Study: We analyzed data to determine when CRS events were most likely to occur (e.g., 60.5% of Teclistamab CRS events occurred during the first step-up dose).
• Act: We refined inpatient stays. For Glofitamab, we moved from continuous stays to a “2-2-2” model (2 days per ramp-up dose). For Epcoritamab, we optimized the protocol to a single 2-day admission on Day 15.
• Seamless outpatient monitoring of patients through nurse practitioner-led outpatient clinic.

Results:

Logistics and Efficiency

• The median time from treatment decision to first dose was 14 days (range 1–57).

Safety and Adverse Events

• CRS was observed in 12/27 patients (44.4%). Most cases were Grade 1 (fever). Only 4 patients required Tocilizumab. No Grade 3+ ICANS events were recorded.
• No cases of late CRS were reported in the community hospitals.

Discussion:

Our data demonstrates a clear “learning curve” and protocol optimization. The move to three 2-day admissions for Glofitamab (total 6 days) allowed patients to stay home between doses, reducing the psychological and logistical burden of a long hospital stay. This intermittent model is particularly effective for regional programs where bed availability is unpredictable.

The successful implementation of the abbreviated inpatient stay with rigorous outpatient monitoring is our program’s future—minimizing inpatient monitoring to only the highest-risk window. While mortality in this heavily pre-treated cohort remains high due to disease progression, the 96% ramp-up completion rate confirms that the standardized protocol prevents early treatment termination due to manageable toxicity.

Conclusions:

By utilizing a PDSA framework to tailor inpatient stays to specific drug risk profiles (6 days for Glofitamab vs. 10 days for Teclistamab), we have established a sustainable and safe model for regional immunotherapy. Prudent utilisation of nurse practitioner-led clinics was pivotal in ensuring continued patient care with built-in safety in an outpatient setting.

Next Steps:

• Expand the “hold bed” protocol to allow for more outpatient starts.
• Integrate automated CRS tracking into the electronic health record.