Hematologist Rafael Fonseca comments on data demonstrated by the PEGASUS study in transplant-ineligible multiple myeloma and expectations for treating appropriate patients with the combination of daratumumab, lenalidomide, and dexamethasone vs other options moving forward.
Rafael Fonseca, MD: Dr Brian Durie and colleagues presented a study, the PEGASUS study, in which they compared their DRd [daratumumab, lenalidomide, dexamethasone] to standard of care. It’s a beautiful demonstration of how real-world data can inform and confirm.
It’s important that the audience understand that real-world data don’t have the purity and ability to solve questions going forward with the same cleanliness, so to speak, as a randomized clinical trial. However, it does allow us to provide very important and powerful confirmatory observations. I have published in this regard.
What Dr Durie shows is that if you actually take a group of patients who would be matched, they would be eligible for that MAIA clinical trial [the triplet comparison]. The real-world MAIA-like combination provides the benefit to patients that was reported in the clinical trial. This is important because people always wonder, “Well, that was in the trial. How does that translate into the real world?” We have a lot more to learn and more data coming in real-world data sets.
Indirect comparisons of data allow us to understand the specifics with regard to items such as time to next treatment, and we can actually start cross-referencing some of those data sets so we can actually do survival analyses.
I’ve also participated in integrating this with claims data sets. You can look at factors such as the total cost of care. A lot of this is very informative and tells a more complete story of what happens when you look at the worth of an intervention, from not only a clinical perspective but a monetary perspective as well.
The results of a study like PEGASUS allow clinicians to have even greater confidence as they decide on appropriate treatment regimens for their patients. The data validate in the real world what we’re seeing in clinical trials. I would love to see many more of those. We’re in the era of big data.
Transcript edited for clarity.