What do you see as the future of MRD?

What do you see as the future of MRD?

What I see being the big important deliverables for MRD in myeloma are, number one, that the FDA will endorse it as a regulatory end for drug approval because that will speed up drug approval instead of waiting in the newly diagnosed setting for five, ten years. We could have the results a year later and the drugs could become available for patients even in the relapse setting instead of waiting four or five six years.

We could also have it after one year. This is what patient needs. We need to move this forward together. Drug companies, academia and patients needs to work together to to make the the FDA making this decision going forward. I also think important deliverables will be to develop blood based and the tools. I think this will change the whole treatment field.

I think that will drive MRD driven treatment decisions. The way I think about it is that I think a patient who gets modern therapy and being monitored with a blood based MRD test, that patient could reach MRD negativity with a chemotherapy free regimen after a certain number of cycles and may collect but not go for a transplant and go right to maintenance.

A patient that is being treated monitored over time. If that patient is found to be sustained MRD Negative for several years, maybe that patient chooses to go off therapy and the MRD testing in the blood would still allow safe monitoring to make sure that there is no early signs of reappearance of the disease. I think this will be very, very important.

And lastly, I do think that the development of bone marrow based tests could maybe increase the sensitivity. So I'm thinking that could be some form of a stepwise approach where maybe a very sensitive bone marrow based technology could be done to confirm a deep response and then a more practical, feasible blood test, even if it's slightly less sensitive, could still be done for long term tracking of the patients.

So I think we will see both the regulatory side, we will see the treatment side, and we will see the technologies side. There was a lot of change that will happen for the better.

In addition to MRD testing, what other testing could be used to help make treatment decisions.

So some future perspectives on MRD tracking in a little bit more broader terms, I think should really emphasize on characterization of the disease to begin with. So when we think about MRD testing, we are basically thinking about it in an arbitrary ways, positive, negative.

We set a threshold, but we know that myeloma can be a very heterogeneous disease across patients and even within the patient, if we perform whole genome, a single cell sequencing of a newly diagnosed patient with myeloma, we can find five or ten different parallel myeloma diseases in the same patient. In every patient we see this. Depending on how the disease composition, what that looks like in the given patient.

If we treat with our best drugs and achieve MRD negativity, if we think about how complicated the disease is across different patients, probably the biological features of the disease in one patient versus another patient could also play a role beyond just MRD So having a less aggressive disease biology and turning MRD negative versus having a slightly more aggressive disease biology turning MRD negative will probably also play a role.

We are not yet there to fully integrate understanding of the disease biology with the testing present absent and to make it even more complicated. We know already now that the immune system also plays an important role on these types of diseases. So I think based on insights we have generated over the past one, two years, that if the immune system stays healthy or it becomes stronger, even that that also can play an important role in controlling and preventing the disease from returning back in the body.

So that means that I think in the future probably that could be focus on profiling the immune system in addition to MRD testing. So this turns into a quite complicated task, both to rule out that there is no disease to characterize the disease before the therapy and also to track the immune system over time. So hopefully we will be able to package a lot of complicated scientific data into simple tests that can be done.

I'm hopeful that that's going to happen.