Expert Reviews Findings From the AURIGA Study in Myeloma

In an interview with Pharmacy Times, Ashraf Badros, MBCHB, discussed findings from the AURIGA study being presented at the International Myeloma Society 2024 Annual Meeting, happening September 25 through 29 in Rio de Janeiro, Brazil.

Q: Can you review the design and end points of the AURIGA study?

Ashraf Badros, MBCHB: This is a multicenter, randomized trial. It was an open label, phase 3 study enrolling newly diagnosed myeloma patients in the US and Canada. Patients were enrolled after completing 4 cycles of induction that did not include CD38 antibody and transplant. And at the time of screening, patients should be in very good partial response or better, and they should be [minimal residual disease]–positive. On screening, patients were stratified by risk, cytogenetic risk, randomized within 6 months of the transplant to 36 cycles of daratumumab plus Revlimid, or Revlimid alone. And we did MRD testing at 12, 18, 24 and 36 months. The primary end point of the study was MRD negative conversion rate at 106 using next generation sequencing after 12 months of maintenance therapy.

Q: What need(s) does daratumumab fulfill in the treatment of myeloma, and how is the AURIGA study furthering its use?

Badros: Daratumumab is a standard of care today, in combination with Revlimid, Velcade, and dexamethasone (RVD) in upfront treatment of multiple myeloma. So, it has an approval from the FDA and there is a definitive trial called the PERSEUS, which was presented here and published in the New England Journal of Medicine, showing that the addition of daratumumab to upfront RVD regimen, followed by transplant, followed by Revlimid maintenance with lenalidomide, led to improvement in progression free survival. This was compared to RVD alone, so there is a clear role in upfront [treatment]. However, there is really no trial to date that has compared the addition of daratumumab to lenalidomide in the maintenance setting, which is the focus of the AURIGA trial. So, this is the first trial to directly compare them in maintenance setting.

Q: What new findings are being presented at IMS 2024 from the AURIGA study?

Badros: This is a primary analysis, which means it's the interim analysis. It's a primary analysis. All the patients completed 12 months of maintenance or discontinued treatment. The median follow up was about 32 months from the trial, and the patients who received daratumumab plus Revlimid did stay longer on the treatment, at 30 months versus 20 months for Revlimid alone. In the intent-to-treat population, so looking at all the patients that enrolled on the trial, the primary end point—which is MRD negativity at 105 negative conversion rate—at 12 months was achieved in 50% of the daratumumab plus Revlimid arm, and 18.8% in the lenalidomide alone arm, which is a statistically significant difference. And that was the primary end point of the study and has been met.