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Data presented at the 2023 American Society of Hematology (ASH) annual meeting demonstrated that adding the anti-CD38 antibody daratumumab (Darzalex) to bortezomib (Velcade), lenalidomide (Revlimid), and dexamethasone (VRd) significantly improved progression-free survival (PFS) versus VRd alone in newly diagnosed, transplant-eligible multiple myeloma.

Pieter Sonneveld, MD, PhD, professor of hematology at the Erasmus University of Rotterdam and Erasmus Medical Center in the Netherlands, explains the latest findings of the PERSEUS study.

Following is a transcript of his remarks:

In this trial, we investigated standard therapy with the same therapy to which daratumumab was added. And the endpoint, the question in fact, was progression-free survival, but also minimal residual disease [MRD] and complete response [CR].

We did the trial of 700 patients in approximately 10 months, and now the follow-up is 4 years. And what we observed is that progression-free survival at 4 years is 84% with daratumumab and 67% without. So this is a considerable difference and we think that's important. And also the hazard ratio for progression-free survival is 0.42, which means that 58% reduction of progression in that during and after the study.

This is important also, I have to add, that the schedule was made more easy for the patient by subcutaneous administration, daratumumab compared with IV in the past. Also, we made the schedule 4 weeks rather than 3 weeks. So the patients tolerated this treatment quite good.

And then during the maintenance, which was daratumumab plus lenalidomide, we stopped daratumumab after 2 years if the patients were in CR and had at least one year of MRD negativity. And this was accomplished in two-thirds of the patients and ongoing. So this will be followed.

So currently VRd is approved in Europe and many centers are using VRd or [daratumumab]-VTd with thalidomide rather than lenalidomide.

I think that the results of this trial warrant approval by EMA [European Medicines Agency], and if so, we expect that it'll be the standard treatment for this group of patients in Europe, Australia, and I think across the world very soon, because people have really been waiting for the results of this trial.

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