EHA 2023 | EMN 27: efficacy and safety of belantamab mafodotin for R/R AL amyloidosis

So we present an interim analysis of a Phase II study that evaluates monotherapy with belantamab mafodotin in patients with relapsed refractory light chain amyloidosis. This is a European myeloma network trial. It will enroll 38 patients – so far we have around 36, we are just two patients behind complete enrollment. And we will present an interim analysis in the first 25 patients with a follow-up of at least three months. The drug is given as a monotherapy, as I said, and it’s given at a dose of 2.5mg per kg every six weeks, and there is a dose reduction to 1.9mg per kg. And also there is a possibility that because of toxicity, someone can increase the interval between the doses. So, the median number of prior lines for the therapies that entered the study and are presented in the analysis is three. However, 75%, about 75%, of the patients have received daratumumab in their prior lines of therapy and about 90% have received bortezomib. And the median number of therapies for patients who are exposed to daratumumab is four. So the overall hematologic response rate in this patient population is 60%. And within this, there are two more pretreated patients, is 56%. So I think it is a significant response probability for these patients who have been heavily pretreated.

Regarding the toxicity, we didn’t see any major new toxicities regarding heart or the kidneys. However, 48% of the patients did develop ocular toxicity grade 3 or 4, and this was actually the major problem in the study, despite the six-week interval between the doses and the dose reductions. However, I think that this is a promising therapy for a certain subgroup of patients with relapsed refractory amyloidosis and perhaps a combination with another drug could further increase the efficacy of the combination and perhaps with longer dosing intervals, we could further reduce ocular toxicity.