Daratumumab vs Observation in High-Risk SMM (Aquila Study) | Meletios Dimopoulos, MD | #ASH24

I'm Meletios Dimopoulos and I’m a professor of hematology and oncology at the University of Athens School of Medicine in Athens, Greece.

And I will be presenting in this meeting the data on the Aquila trial.

This is a study which compared a 9638 monoclonal antibody for the treatment of patients with smoldering myeloma, meaning asymptomatic myeloma, who were defined as high risk for progression.

And the comparison was with observation.

We know that the standard approach for patients with smoldering myeloma is observation. However, we know that there are certain patients that have some features that could predict an earlier, rather a later progression to symptomatic disease.

So for these patients who would like to avoid, a damage of the bones, of the kidneys, or severe anemia.

So there are several studies that are investigating whether treatment, before they develop any symptoms or signs, will improve their outcome.

In this Aquila study, we selected patients that had high risk features, meaning we could predict that these patients would develop symptomatic disease in the next 2 or 3 years.

And we randomized them to receive either daratumumab for three years or observation.

So what we saw is that by administering daratumumab, we were able to decrease by 50% the chance to progression.

So there was a benefit by reducing the probability of progression and also by reducing the skeletal related events, renal impairment, severe anemia.

And also there was a trend to improve the survival of the patients.

So we believe that with this Aquila study, there may be a new standard of care for selected patients who have what we call high risk smoldering myeloma.

Definition was based on characteristics that were available in 2015. Because this study was designed ten years ago.

So these were patients that had more than 20% bone marrow plasma cells, more than three grams of monoclonal protein, an abnormal, free light chain ratio, more than eight. And those with IgA type of myeloma.

There were IgG patients included if they fulfilled the criteria.

But IgA by itself was defined as a high risk feature.