Dara + Len vs Len Alone as Maintenance Therapy -AURIGA | Ashraf Badros, MD | IMS 2024

So my name is Ashraf Badruss. I'm a professor of medicine and director of the multiple myeloma service at the University of Maryland, Greenbaum Comprehensive Cancer Center. I will share with you today the presentation we had at the International Myeloma Society about the Uraiga trial. Uraiga was the first trial to directly compare the addition of Daratumimab to lenalidomide versus senalidomide alone, which is the standard of care for maintenance after transplant. We reported the primary results of the study. The patients enrolled were newly diagnosed. All of them had induction treatment for at least four cycles followed by transplant. Within six months of the transplant date, they were randomized on our trial. To be eligible for the trial, the patient had to achieve a very good partial response or better, had MRD positive signal, meaning there are some residual myeloma cells, and more importantly have not received Daratumimab or Isatoximab, which is a monoclonal antibody against CD38 during induction or after the transplant. The patient were randomized one-to-one, meaning one on each arm, and they received treatment with lenalidomide initially at 10 milligrams, increased to 15 if well-calorated. Daratumimab is given in a standard fashion weekly for eight weeks, every other week for two months, and monthly afterwards. For up to 36 months, the primary endpoint of the study was to assess MRD negativity at 12 months, which was achieved in 50.5 percent of the patients on the Daratumimab-lenalidomide R and 18.8 percent in the patients who received lenalidomide. This was a statistically significant difference, indicating deeper responses with the use of Daratumimab and lenalidomide. This was checked at 10 to the 5th, which is detecting one myeloma cell in 100,000. The median follow-up on the study was 32 months. The median progression pre-survival at 30 months was 83 percent for the Daratumimab-lenalidomide versus 66 percent for lenalidomide at all. That translated into 47 percent reduction in the risk of progression or death. For patients on Daratumimab and lenalidomide. Also noted during the study duration, the deeper response saw the patient that achieved an MRD negativity at 12 months as weekly treatment MRD negativity rate improved to 60 percent for the Dararevlamid R. And complete responses also deepened. So we noted 75.8 percent complete response for the Daratumimab-lenalidomide R versus 61 percent for the lenalidomide R model. Like any treatment we give, there are some side effects, but they did not really impair our ability to continue treatment. Most of the patients on the Daratumimab-lenalidomide stay with the treatment for 30 months versus 20 months for the lenalidomide R and that was translated into more ability to tolerate the doublet treatment with the two drugs. The most common side effects were infection and some cytopenia, meaning decreasing the counts, mostly neutrophils. However, some patients in the Daranidomide R discontinued treatment at 13 percent, which is slightly higher than lenalidomide R model at 8 percent. We believe that staying longer on the treatment will lead to more time to report side effects and to discontinue treatment. So we believe that the side effects are more balanced if we count the time frame of the duration of therapy for each harm. There was no new safety signal noted on this most of the side effects have been seen before in the multiple trials. Our trial shows that the addition of Daratumimab to lenalidomide achieved higher MRD negativity rate at 10 to the 5th at 12 months, led to deeper responses with complete response rates and improved progression free survival after transplant with no new safety concerns and really the results support adding Daratumimab to lenalidomide not only during induction treatment, which is now standard of care using Daratumimab with VELC, Revlimid and Tex, but also to lenalidomide during mint.