TABLE 1.
Recommended Belantamab Mafodotin Dose Modifications Based on Eye Examination Findings According to the Keratopathy and Visual Acuity Scale a
| Grading Category: US/EU | Eye Examination Findings by KVA Scale | Recommended Dose Modifications |
|---|---|---|
| Grade 1/mild | Corneal examination finding(s) | Continue treatment at the current dose |
| Mild superficial keratopathy b | ||
| Change in BCVA c | ||
| Decline from baseline of 1 line on Snellen Visual Acuity | ||
| Grade 2/moderate | Corneal examination finding(s) | Withhold treatment until improvement in both corneal examination findings and change in BCVA to grade 1 (mild) or better and resume at the current dose; consider resuming at a reduced dose of 1.9 mg/kg |
| Moderate superficial keratopathy d | ||
| Change in BCVA | ||
| Decline from baseline of 2 or 3 lines on Snellen Visual Acuity and ≤20/200 | ||
| Grade 3/severe | Corneal examination finding(s) | Withhold treatment until improvement in both corneal examination findings and change in BCVA to grade ≥1 (mild) and resume at a reduced dose; for worsening symptoms that are unresponsive to appropriate management, consider discontinuation |
| Severe superficial keratopathy e | ||
| Change in BCVA | ||
| Decline from baseline by more than 3 lines on Snellen Visual Acuity and not worse than 20/200 f | ||
| Grade 4/severe | Corneal examination finding(s) | Consider permanent discontinuation of treatment; if continuing treatment, withhold treatment until improvement in both corneal examination findings and change in BCVA to grade ≥1 and resume at reduced a dose |
| Corneal epithelial defect g | ||
| Change in BCVA | ||
| Snellen Visual Acuity <20/200 f |
Abbreviations: BCVA, best‐corrected visual acuity; KVA scale, the Keratopathy and Visual Acuity scale; EU, European Union; US, United States.
DREAMM‐2 used a protocol‐defined scale that combined slit‐lamp examination findings with an assessment of BCVA. 24 This scale was renamed the KVA scale, as shown here, and is included in the current US and EU labels. This table provides a combined summary of these grades and dose‐modification guidelines in the current US and EU labels. 21 , 22 Recommendations unique to the EU label are italicized, whereas recommendations unique to the United States label are underlined; the EU label has the categories mild, moderate, and severe, with severe covering the KVA and US label grades 3 and 4. The severity category is defined by the most severely affected eye because both eyes may not be affected to the same degree. Prescribing physicians should follow the specific dose‐modification guidelines for corneal event management outlined in their local prescribing information.
This includes mild superficial keratopathy (documented worsening from baseline) with or without symptoms.
These are changes in visual acuity because of treatment‐related corneal findings.
This includes moderate superficial keratopathy with or without patchy microcyst‐like deposits, subepithelial haze (peripheral), or a new peripheral stromal opacity.
Severe superficial keratopathy with or without diffuse microcyst‐like deposits involving the central cornea, subepithelial haze (central), or a new central stromal opacity.
The EU label specifies only decline from baseline of more than 3 lines, without separation by Snellen Visual Acuity better or worse than 20/200.
Corneal epithelial defect such as corneal ulcers. The EU label states that these should be managed promptly and as clinically indicated by an eye care professional.