Among patients treated with belantamab mafodotin in the DREAMM-2 trial, 84% experienced AEs of grade ≥3, of which 57% were treatment-related.[33] The most common TRAEs were keratopathy (microcyst-like epithelial changes [MECs]) (46%), change in best-corrected visual acuity (BCVA) (31%), thrombocytopenia (22%), anemia (21%), fatigue (11%) and reduced lymphocyte count (13%) (Table 2). The cytotoxic drug monomethyl auristatin F (MMAF) is known to cause ocular symptoms, explaining the high occurrence of keratopathy in patients treated with belantamab mafodotin. However, ocular symptoms were manageable through dose reductions or delays and at 13-months follow-up no treated patient had permanent complete vision changes of loss. Although dose modifications (delays or reductions) to manage AEs were common, there was minimal impact on patient responses to belantamab mafodotin. A more detailed view on the occurrence and the management of ocular side effects related to belantamab mafodotin treatment will be provided in submodule 3.

Table 2. Adverse events of grade ≥3 with belantamab mafodotin in patients with relapsed/refractory multiple myeloma. AE, adverse event; AST, aspartate aminotransferase; BCVA, best corrected visual acuity; MECs, microcyst-like epithelial changes. Adapted from Lonial et al. 2021.[33]

AEs ≥Grade 3 occurring in ≥5% of patients, n (%)*	Belantamab Mafodotin 2.5 mg/kg (N = 95)
Any event	80 (84)
Eye Examination Finding
Keratopathy (MECs)^†	44 (46)
Change in BCVA	29 (31)
Thrombocytopenia^‡	21 (22)
Anemia	20 (21)
Blurred vision^§	4 (4)
Nausea	0 (0)
Pyrexia	4 (4)
AST increased	2 (2)
Infusion-related reaction	3 (3)
Fatigue	2 (2)
Neutropenia	10 (11)
Dry eye	1 (1)
Hypercalcemia	7 (7)
Lymphocyte count decreased	12 (13)
Pneumonia	6 (6)

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