Eric Schaefer

Bispecific antibodies are novel immunotherapies approved for the treatment of patients with relapsed or refractory multiple myeloma (MM). While these therapies induce deep and durable responses, they are associated with adverse events, such as cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, that require specific protocols for monitoring, prevention, and treatment. Due to the potential risk of cytokine release syndrome and immune effector cell–associated neurotoxicity syndrome, current US labeling recommends inpatient administration during step-up dosing of bispecific antibodies, which typically occurs in academic centers and can often restrict the number of patients that can be treated. The administration of bispecific antibodies in the outpatient and community setting can enhance the patient experience and reduce resource use, which is a barrier to the widespread uptake of these treatments. With bispecific antibodies being evaluated in earlier lines of therapy for MM, the broader use of these agents will underscore the need for more accessible and less resource-intensive options that ensure safe outpatient administration. In this Viewpoint, we aim to provide practical recommendations built from our own real-world perspectives and case examples for institutions seeking to implement remote patient monitoring (RPM) strategies to support the outpatient dosing of bispecific antibodies in patients with MM. We discuss how the use of RPM has the potential to improve adverse event detection and management, improve patient outcomes, and decrease resource use and costs. While specific approaches will vary based on the needs of each treatment center, our experiences suggest that RPM implementation can be safe and feasible for both academic and community practices.

PURPOSE: Infection remains a leading cause of death in patients with hematologic malignancies, necessitating better strategies to monitor for and identify infections earlier. In this study, we investigated whether an electronic patient-reported outcome (ePRO)–based remote therapeutic monitoring (RTM) platform can reduce infection-related health care utilization compared with traditional monitoring methods. METHODS: This was a retrospective cohort study of adults with hematologic malignancies receiving anticancer therapy at five community clinics with the Canopy ePRO-based RTM platform integrated into their electronic medical record. The dual primary outcomes of this study were infection-related health care utilization (emergency department [ED] visits and hospital admissions) and outpatient antibiotic use during follow-up. Propensity score weighting was used to balance patient characteristics between groups. Health care costs were estimated by applying unit costs to weighted event rates for ED visits and hospitalizations. RESULTS: A total of 349 patients were enrolled and active in the ePRO program (active ePRO) and 1,296 were not enrolled. In both unadjusted and weighted adjusted analyses, patients in the active ePRO group had significantly higher rates of outpatient antibiotic use (weighted relative risk ratio [RR], 1.20 [95% CI, 1.02 to 1.42]) and lower incidences of infection-related ED visits (weighted RR, 0.66 [95% CI, 0.46 to 0.96]) and hospital admissions (weighted RR, 0.48 [95% CI, 0.25 to 0.89]). Estimated combined savings with ePRO was USD$977,695 for every 1,000 patients per year. CONCLUSION: ePRO RTM during treatment for hematologic malignancies was associated with a significant reduction in infection-related health care utilization and cost of care. ePRO monitoring may be increasingly beneficial as therapies with more complex toxicity profiles gain traction.

Time to Onset of First Hepatotoxicity Event

Preclinical efficacy study with xenograft models derived from patients with SCLC

Representativeness of Study Participants

Mean (± SD) preliminary ABBV-011 ADC concentration-time profiles following IV infusion of ABBV-011 (0.3 to 2.0 mg/kg) in cycle 1

Overview of Treatment Response by Line of Treatment and Platinum Sensitivity

Preliminary Pharmacokinetic Parameters of ABBV-011 ADC Following IV Infusion of ABBV-011 1 mg/kg in Cycle 1 (n=40)

Definition of dose-limiting toxicities and methods for patient-derived xenograft studies