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ASH 2020 | DARIA: daratumumab with ixazomib and dexamethasone for R/R myeloma

Evangelos Terpos, MD, PhD, National and Kapodistrian University of Athens, Athens, Greece, discusses the findings of the Phase II DARIA study (NCT03746652) of daratumumab efficacy with ixazomib and dexamethasone in relapsed/refractory (R/R), newly diagnosed multiple myeloma patients, after prior use of lenalidomide. The ongoing study aims to evaluate the effectiveness of the anti-CD38 monoclonal antibody daratumumab as a second-line therapy, with overall response rate (ORR) as the primary endpoint. Preliminary endpoints calculated from 15 patients with evaluable data: ORR = 60%, with 47% achieving very good partial responses. With a 12-month progression-free survival of 54% and a rapid response rate (median time to partial response was 1 month), the trial data supports this treatment combination as a second-line myeloma therapy. This interview took place during the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, 2020.

Transcript (edited for clarity)

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.

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