The DARIA study is a phase two study, which aimed to evaluate the combination of daratumumab, ixazomib, and dexamethasone in patients with relapsed/refractory myeloma who have received one prior treatment based on lenalidomide. The majority of these patients in the DARIA study were refractory to lenalidomide, and specifically, 60% of them are refractory to date.
We present preliminary data based on 15 patients who received the combination, and as I mentioned previously, 60% of them were refractory to lenalidomide...
The DARIA study is a phase two study, which aimed to evaluate the combination of daratumumab, ixazomib, and dexamethasone in patients with relapsed/refractory myeloma who have received one prior treatment based on lenalidomide. The majority of these patients in the DARIA study were refractory to lenalidomide, and specifically, 60% of them are refractory to date.
We present preliminary data based on 15 patients who received the combination, and as I mentioned previously, 60% of them were refractory to lenalidomide. Their response rate was 60%. 47% of the patients had achieved the VGPR or better. They achieved this at the median time of less than one month. Then PFS of course of only these 15 patients, the probability for progression-free survival after 12 months is around 54%. And regarding the safety, we can say that it is a rather safe combination, grade three or four adverse events, including mainly through cytopenia in 40% of the patients that are the lower extent neutropenia.
And I think that these preliminary results suggest that the combination of the daratumumab, ixazomib, and dexamethasone resulted in rapid responses. But, the responses were not very deep to date. The 12-month PFS service is at 54% and the safety profile is very good.
So we want to see the final analysis of the study that has completed the recruitment in order to know better what will be the results. Then it seems that it is not a very strong combination for patients who progress on lenalidomide. Although, I have to say that several combination in this setting has not produced very encouraging results. So I think that lenalidomide refractoriness especially on second-line remains an unmet need, and we need more therapies to be evaluated in this setting.