The most common adverse reactions (≥20%) were keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, and fatigue. The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased, platelets decreased, hemoglobin decreased, neutrophils decreased, creatinine increased, and gamma-glutamyl transferase increased.1
Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).1
Adverse events were managed with supportive care and dose modifications1:
Dosage interruptions due to an adverse reaction occurred in 54% of patients.
Adverse reactions resulting in dosage interruptions occurred in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%).
Dose reductions due to an adverse reaction occurred in 29% of patients.
Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).
No permanent, complete loss of vision was reported in the DREAMM-2 study.2
At 6 months, 8% of patients treated with BLENREP had permanently discontinued due to an adverse reaction. Keratopathy was the most frequent adverse reaction to cause discontinuation at 2.1%.1
The safety data at the 13-month follow-up further establishes the safety profile observed at 6 months.3
Ocular adverse reactions in the pooled safety population
Pooled data at 6 months (N = 218)
Ocular adverse reactions occurred in 77% of 218 patients in the pooled safety population.1*
Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%)
Among patients with keratopathy (n = 165):
49% of patients had ocular symptoms
65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye)
34% had both ocular symptoms and visual acuity changes
At 6 months, in the 2.5-mg/kg cohort, 8% of patients treated with BLENREP had permanently discontinued due to an adverse event.
The most frequent adverse reaction resulting in permanent discontinuation was keratopathy (2.1%).
No permanent, complete loss of vision was reported in the DREAMM-2 study.2
At the 13-month follow-up, in the 2.5-mg/kg cohort (N = 95)4
72% of patients experienced keratopathy
56% of patients had ocular symptoms and/or visual acuity changes3
Symptoms included those such as blurred vision and dry eye. Visual acuity change was at least 2 lines on Snellen Visual Acuity in the better-seeing eye
18% of patients experienced a change in BCVA to worse than 20/40*
1% of patients experienced a change in BCVA to 20/200 or worse
9% of patients treated with BLENREP 2.5 mg/kg discontinued due to an adverse event.3
Of these patients, 3% discontinued treatment due to corneal events
keratopathy (1%)
changes in visual acuity (1%)
blurred vision (1%)
No permanent, complete loss of vision was reported in the DREAMM-2 study.2,4
Adverse events