IMS 2026 | VRAT for monitoring ocular toxicity with belantamab mafodotin

The VRAT stands for Visual Related Animastic Tool and essentially is a patient reported outcome questionnaire that we developed outside of the Ocular Surface Disease Index which is a validated patient reported outcome used for corneal disease. It’s a simple nine question set that you ask a patient, which can be asked either by a doctor or a nurse, and it allows you to understand whether the patient is experiencing any ocular symptoms or not. The rationale for developing this is that belantamab mafodotin is a very effective treatment when used for multiple myeloma in combination with bortezomib or pomalidomide, but does cause some eye toxicities. As a consequence, patients have to undergo ocular testing at baseline and before each treatment. So in the ProMMise-D clinical trial, what we set out to do was to see whether the VRAT questionnaire could be used in place of ocular assessments. So in stage one, all patients had an ocular assessment and in parallel also had a VRAT questionnaire. Overall, we enrolled 40 patients into stage one of this study, and these patients had 80 paired assessments between an ocular assessment and a VRAT. And we were able to correlate the performance of the VRAT with the ocular assessment. Essentially, when we look at the results, we only missed one grade three keratopathy. So that’s one out of 80, which is essentially 1.3%. This means that the specificity of the VRAT for picking up significant keratopathy is 98.3% has a very high negative predictive value for detecting severe keratopathy. However, the positive predictive value was lower at 27%. Essentially, what that means was that the VRAT was positive, but when an ocular assessment was performed, it was found to be negative. Hence, these were false positive tests. Now, the question is, why were we getting false positives? And actually, the rationale is that the VRAT is a questionnaire. And because it’s a questionnaire, it is subjective inherently to both the healthcare professional who’s asking the questions and is interpreting the results, and the patient who is listening to the questions and is giving the answers. And so what we found in this study, because it was being run at 15 different hospitals and lots of different doctors and nurses were asking these questions, that you needed to educate the healthcare professional about the questionnaire to ensure that there was accuracy and reproducibility of the questionnaire. And so I think once you can do that, then the VRAT will be a much more accurate tool. Just to say that we are now enrolling into stage two of the trial. And in stage two of the study, patients will only be dosed according to the VRAT questionnaire, and there are no mandated ocular assessments.

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