MM-470 Exploring Alternative Dosing Regimens of Single-Agent Belantamab Mafodotin on Safety and Efficacy in Patients With Relapsed or Refractory Multiple Myeloma (RRMM): DREAMM-14

Abstract

Belantamab mafodotin (belamaf) is a first-in-class, monomethyl auristatin F (MMAF) containing, B-cell maturation antigen-directed antibody-drug conjugate (ADC). Ocular events are common and expected with belamaf and other MMAF-containing ADCs. DREAMM-14 (NCT05064358) investigates whether an improved benefit/risk profile of single-agent belamaf can be achieved by modifying the dose, schedule, or both, relative to the approved dosing regimen (2.5 mg/kg Q3W) to reduce ocular events without clinically meaningful decrease in efficacy. This Phase II, randomized, open-label study includes adults with RRMM and ≥3 prior lines of therapy (LOT), including an anti-CD38 monoclonal antibody, an immunomodulatory agent, and a proteasome inhibitor. Patients with corneal epithelial disease (except nonconfluent superficial punctate keratitis) or with prior exposure to BCMA-targeted therapies, or ADCs are excluded. Patients are randomized into Arms A-D (n=40 each) and Arm E (n=20) in parallel stratified by the International Staging System (I vs II vs III) and prior LOT (3 vs ≥4). Belamaf is administered as follows - Arm A: 2.5 mg/kg Q3W; Arm B: 1.9 mg/kg Q3W; Arm C: 2.5 mg/kg Q6W; Arm D: 1.9 mg/kg Q6W; Arm E: 1.9 mg/kg Q6W. In Arm E, ocular event-related dose modifications are based on oncology staff assessment of ocular symptoms and visual acuity plus eye care professional (ECP)-assessed corneal findings. Ocular event-related dose modification in Arms A-D will be performed by oncologists using ECP-provided data and guided by a modified Keratopathy and Visual Acuity scale. Patients in all Arms have response assessments, safety assessments, and ECP-performed ophthalmic exams Q3W regardless of dosing schedule. The primary endpoint is incidence of ocular events. Key secondary endpoints are ocular safety/tolerability, overall safety/tolerability, pharmacokinetics, and efficacy outcomes. Follow-up for progression-free survival is Q3W until progressive disease, start of new anticancer therapy, withdrawal of consent, end of study, or death. Status: First patient first visit was 03Mar22. GSK (Study 209628); drug linker technology licensed from Seagen Inc.; mAb produced using POTELLIGENT Technology (BioWa). ©2022 American Society of Clinical Oncology, Inc. Reused with permission. This abstract was accepted and presented at the 2022 ASCO Annual Meeting. All rights reserved.