Blenrep Adverse Reactions

Summary of the safety profile: Adverse reactions described in this section were reported from 95 patients who received BLENREP 2.5 mg/kg in study 205678. The most frequent adverse reactions (≥30%) were keratopathy (71%) and thrombocytopenia (38%). The most commonly reported serious adverse reactions were pneumonia (7%), pyrexia (7%) and IRRs (3%). Permanent discontinuation due to an adverse reaction occurred in 9% of patients who received BLENREP with 3% related to ocular adverse reactions.
Tabulated list of adverse reactions: Table 5 summarises adverse drug reactions that occurred in patients receiving the recommended dose of BLENREP 2.5 mg/kg once every 3 weeks.
Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000). Within each frequency grouping, where relevant, adverse reactions are presented in order of decreasing seriousness. (See Table 5.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Corneal adverse reactions: Corneal adverse reactions were assessed in Study 205678 from the safety population (n=218) which included patients treated with 2.5 mg/kg (n=95). Eye disorder events occurred in 74% patients and the most common adverse reactions were keratopathy or microcyst-like epithelial changes in corneal epithelium [identified on eye exam, with or without symptoms] (71%), blurred vision (25%), and dry eye symptoms (15%). Decreased vision (Snellen Visual Acuity worse than 20/50) in the better eye was reported in 18% and severe vision loss (20/200 or worse) in the better seeing eye was reported in 1% of patients treated with belantamab mafodotin.
The median time to onset of Grade 2 or above corneal findings (best corrected visual acuity or keratopathy on eye examination) was 36 days (range: 19 to 143 days). The median time to resolution of these corneal findings was 91 days (range: 21 to 201 days).
Corneal findings (keratopathy) led to dose delays in 47% of patients, and dose reductions in 27% of patients. Three percent of patients discontinued treatment due to ocular events.
Infusion-related reactions: In clinical studies, the incidence of infusion-related reactions (IRR) with belantamab mafodotin 2.5 mg/kg was 21%, and most (90%) occurred during the first infusion. Most IRRs were reported as Grade 1 (6%) and Grade 2 (12%) while 3% experienced Grade 3 IRRs. Serious IRRs were reported by 4% of patients and included symptoms of pyrexia and lethargy. Median time to onset and the median duration of the first occurrence of an IRR was 1 day. One patient (1%) discontinued treatment due to IRRs, experiencing Grade 3 IRRs at first and second infusion. No Grade 4 or 5 IRRs were reported.
Thrombocytopenia: Thrombocytopenic events, (thrombocytopenia and platelet count decreased) occurred in 38% of patients treated with belantamab mafodotin 2.5 mg/kg. Grade 2 thrombocytopenic events occurred in 3% of patients, Grade 3 in 9%, and Grade 4 in 13%. Grade 3 bleeding events occurred in 2% of patients and no Grade 4 or 5 events were reported.
Infections: Upper respiratory tract infections were commonly reported across the belantamab mafodotin clinical programme and were mostly mild to moderate (Grade 1 to 3), occurring in 9% of patients treated with belantamab mafodotin 2.5 mg/kg. There were no SAEs of upper respiratory tract infections reported. Pneumonia was the most frequent infection reported in 11% of patients treated with belantamab mafodotin 2.5 mg/kg. Pneumonia was also the most frequent SAE, reported in 7% of patients. Infections with a fatal outcome were primarily due to pneumonia (1%).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.