Belantamab mafodotin has been approved by the FDA for the treatment of patients with RRMM

The U.S. Food and Drug Administration (FDA) has approved belantamab mafodotin, an anti-B cell maturation antigen (BCMA) monoclonal antibody–drug conjugate (ADC), as a single agent, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) who have received at least four lines of prior treatment, including a proteasome inhibitor, an immunomodulatory drug (IMiD®), and an anti-CD38 antibody.¹

The approval was based on the results of the DREAMM-2 trial (NCT03525678), which demonstrated a clinically meaningful overall response rate of 31% (97.5% CI, 20.8–42.6) in patients with RRMM. These patients had a median of seven prior therapies and received treatment with single-agent belantamab mafodotin at a dose of 2.5 mg/kg every 3 weeks. The progression-free survival was 12 months (95% CI, 3.1–not estimable), with a median of 2.9 months. The median duration of response had not been reached at the 6-month analysis, but the documented median time to first response thus far was 1.2 months (95% CI, 0.7–1.4).

Overall, belantamab mafodotin was tolerable with fast, deep, and durable responses in this heavily pre-treated patient population. The most reported Grade 3/4 adverse events (occurring in ≥ 20% of patients) were keratopathy (27%), thrombocytopenia (20%), and anemia (20%).² Bone pain and fatigue were alleviated, with ratings dropping from 6.4 to 4.0 and 8.0 to 5.5 (on a scale 0–10), respectively.³

Society for Immunotherapy of Cancer (SITC) recommendations for the use of belantamab mafodotin³

• The optimal indications for ADC therapies are not yet established. Belantamab mafodotin has been studied in patients with RRMM after failing multiple lines of therapies, including proteasome inhibitors, IMiDs, and anti-CD38 antibodies
• Even though patients who had prior allogeneic hematopoietic stem cell transplantation (allo-HSCT) were excluded from the DREAMM-1 and DREAMM-2 studies, based on knowledge of the mechanism of action of ADCs, patients who have had prior allo-HSCT can be considered for belantamab mafodotin treatment
• Patients with significant renal insufficiency, plasma cell leukemia, and hepatic impairment were excluded from clinical trials
• Belantamab mafodotin may be unsuitable for patients with severe cytopenias, including thrombocytopenia, or pre-existing corneal disease
• Ophthalmological examination should be provided to patients prior to receiving belantamab mafodotin, as ocular toxicity is one of the main reported adverse events
• There was no benefit from prophylactic administration of steroid eye drops, but preservative-free lubricant eye drops may be used to manage symptoms such as dryness, blurry vision, or photophobia
• In cases where corneal toxicity is moderate-to-severe, briefly stop therapy until resolved to Grade ≤ 1 and improvement of corneal changes is confirmed, then restart with a lower dose
• Treatment can be restarted once keratopathy, or other adverse events such as cytopenias, have improved to Grade ≤ 1. Dose reduction from 2.5 mg/kg to 1.9 mg/kg may be considered
• In the initial studies, patients were monitored every week; assessments included complete blood counts and complete metabolic panels. This was reduced to occur every treatment cycle once the blood counts normalized
• Many patients experience a delayed response; therefore, it is recommended that patients receiving ADC therapy should continue as long as the disease is stable or responses improve and treatment is tolerable

The full prescribing information can be found here.