Presentation (CTI)

OBJECTIVES: Belamaf is being investigated after first relapse or later in phase 3 RRMM studies: DREAMM-7 (NCT04246047; belamaf with bortezomib and dexamethasone [BVd]) and DREAMM-8 (NCT04484623; belamaf with pomalidomide and dexamethasone [BPd] in lenalidomide-exposed patients). The regimens demonstrated significant progression-free survival (both BVd/BPd) and overall survival (BVd) benefits, and 88% (DREAMM-7)/90% (DREAMM-8) of patients experienced extended dosing intervals, with administration burden reducing over the first year (Y). Administration burden in patients on treatment was evaluated for BVd/BPd versus intravenously (IV) administered second-line-or-later standards of care, IsaKd/DKd/Kd.
METHODS: A model estimating administration burden per patient receiving BVd/BPd/IsaKd/DKd/Kd for the first 2 years of treatment was developed. Dosing regimens were obtained using weekly individual patient-level dosing data from DREAMM-7/DREAMM-8 (BVd/BPd), and from published protocols (IsaKd/DKd/Kd). Administration burden inputs (administration number, clinic visits, and chair/monitoring [including ocular exam for BVd/BPd] durations) for the IV and subcutaneous (SC) agents were sourced from published protocols/clinician input. Oral pomalidomide/dexamethasone were assumed to not require administration visits. Reported results are means per patient on treatment.
RESULTS: For BVd, 9.1/9.7 IV belamaf/SC bortezomib administrations and 10.7 chair/monitoring hours were required in Y1, with 6.6/0.0 administrations and 6.6 hours in Y2. For BPd, 6.2 IV belamaf administrations and 6.2 chair/monitoring hours were required in Y1, with 3.3 administrations and 3.3 hours in Y2. For IsaKd, 28.0/78.0 IV isatuximab/carfilzomib administrations and 80.3 chair/monitoring hours were required in Y1, with 26.0/78.0 administrations and 78.0 hours in Y2. For DKd, 24.0/78.0 SC daratumumab/IV carfilzomib administrations and 70.3 chair/monitoring hours were required in Y1, with 13.0/78.0 administrations and 67.2 hours in Y2. Kd required 78.0 IV carfilzomib administrations in each year, with 66.3 (Y1) and 65.0 (Y2) chair/monitoring hours. Sensitivity analyses were consistent with primary analyses. Alternative administration times and costs were also explored.
CONCLUSIONS: BVd/BPd are associated with substantially lower administration burden versus IsaKd/DKd/Kd. Funding: GSK