Today we will present the interim analysis of the EMN27 study. This is a study that evaluates the efficacy and the safety of belantamab mafodotin as a monotherapy in patients with relapsed or refractory amyloidosis. This study tries to evaluate the drug in a difficult to treat population since there are no approved therapies for these patients. Also today we have more and more patients treated with daratumumab and bortezomib at first line, we need a drug to treat them in case of relapse or lack of adequate response to the aforementioned therapies.
This is a phase II study; belantamab mafodotin is given as a monotherapy. The initial plan is to enrol 38 patients; we have already enrolled 36 and we will present the data for the first 25 patients. Most of the patients have been exposed to daratumumab previously, 70% of the patients, and the median number of prior therapies is three for the whole cohort and four for the subgroup of patients who have been exposed to daratumumab. The drug is given every six weeks for a maximum of one year of therapy.
The overall response rate is significant, it’s 60% across all patients. Among the daratumumab exposed or refractory patients it’s 56%. So this is a significant response rate for this heavily pre-treated population. There was no new signal of toxicities regarding cardiac and renal toxicity.
In summary, this is a study showing that belantamab mafodotin can be a new option for some patients with relapsed or refractory amyloidosis. Perhaps the next step should be to evaluate the drug in combination with another agent in this patient population. Thank you very much.