Myeloma Community Responds Positively to Expanding Role of MRD

C. Ola Landgren, MD, PhD, professor of medicine and chief of the myeloma division and the Myeloma Institute at the Sylvester Comprehensive Cancer Center at the University of Miami, discusses the feedback he received on minimal residual disease (MRD) at this year’s Miami Myeloma MRD Meeting in April.

Landgren says that at this year’s meeting, the first after the FDA approved the use of MRD as a trial end point, he heard excitement about new study designs using MRD in development. This can include creating a single trial that can support accelerated approval based on MRD and regular approval based on progression-free survival (PFS) rather than separate phase 2 and 3 studies.

There is also interest in using MRD to guide treatment approaches such as intensifying or stopping treatment based on MRD. Patients and physicians are eager to use blood-based MRD testing to avoid frequent bone marrow biopsies.

According to Landgren, the workshop has continued to have positive discussions and involve different stakeholders including researchers, clinicians, and patients attending. The ultimate step he hopes to see is using MRD negativity to find a curative regimen for multiple myeloma.

TRANSCRIPTION

0:10 | The feedback we hear is that people are very excited about MRD going forward in the field for trial designs and how new study designs could be developed. Instead of using a single-arm study where you look for the early end point for accelerated approval, and then you do a randomized trial where you capture PFS, you could think of a randomized trial right away. You could read out MRD first, and then you power the study so you can read out PFS from that same study years later, so one study can deliver everything. That's what the FDA wants to see, and that's what academia is discussing.

0:54 | I mentioned before that there is a lot of interest in using MRD for decision making. It goes without saying that the interest in new blood-based technologies is great. Patients are asking, “Can there be blood-based tests, so I don't have to do bone marrow biopsies all the time?”

1:22 | All these different perspectives were addressed. People have reached out and they were very excited. People want to come and talk more about it. We even had patients attending this year sharing their perspective, which I think is the future of medicine—to have everyone involved, not only the medical field and the developers with all the technologies, but of course, the patients. We will continue to have an inclusive leadership. We want to invite anyone who is interested, and we want to drive the field forward. Ultimately, what we would like to do is to see how we can use MRD negativity as a tool to develop a cure for the disease, and that's the No. 1 goal for the field.