What are the unmet needs and challenges in the relapsed/refractory myeloma setting?

What are the unmet needs and challenges in the relapsed and refractory myeloma setting?

I think the the biggest challenge is when we develop therapies for relapsed disease, we typically do clinical trials. You know, that are called first in human.

So if there are therapies that kind of make sense that we have scientific rationale and, you know, rationale from studies done in the lab and we want to bring them into the clinic, the criteria for putting patients on those trials are very stringent. they are very, you know, you want to have a certain, blood count level to go into a clinical trial, a certain, organ function, heart function and all of those things.

And the disease also has to have, measurable protein, you know, defined by the international myeloma, working Group. In the real world, however, you know, are most you know, most patients, you know, do not fall under those different categories. Right. So so the big challenge is reconciling that difference once the therapy does get approved.

So I think this is where looking at what happens to myeloma patients in regular clinical practice and studying the drugs in those kind of settings is very important.

The other important area is patients who have highly aggressive myeloma, because many times, as we are trying to enroll patients on studies, you know, there is a washout period from previous treatments for 2 to 3 weeks. Well, some patients don't have that much time to get on study. So, you know, the more aggressive kind of myeloma is, myeloma that’s inflicting and organ damage on patients. You know, they they end up not enrolling on clinical trials and getting other treatments, you know, So I think that's another important challenge that we have.

The third challenge is, you know, equitable enrollment on clinical trials. So so making clinical trials more inclusive of, you know, our minority patients.

And that's, you know, all of these things, you know, we are proactively working towards, as in myeloma, you know, community research, community in general. And this is where, you know, having good partnerships with patient advocacy organizations is also helping. But I think a lot of work here has been done over the past five or six years. And we are improving, you know, outcomes in each of our participation in clinical trials from each of these, you know, areas of unmet need

I think the biggest need right now is having treatments that target other markers on myeloma cells.

So although patients can have very good responses to BCmA directed therapies, we know that in the vast majority of cases, ultimately myeloma will come back and we've discussed how it is possible to get retreatment with another BCMA directed therapy. But the larger issue is that those responses tend not to be, very, very long duration.

And so a great unmet need is having other targets that we can go after to, hit the myeloma in a slightly different way. And there are several other markers that are under development as targets for myeloma. And those targets could be used to make different versions of the bispecific antibodies or different Car-T cells. and there are some other approaches that are also currently under development.

In the relapsed myeloma setting, the relapsed refractory myeloma setting, we still have unmet needs. And primarily we the patients who have relapsed disease will almost always have an additional relapse. And don't we haven't developed a curative therapy yet. And so despite the excitement about Car-T cells and the excitement about bispecific patients are still relapsing after those therapies.

So we need we still need new therapies. We need new targets. We need new medications. We need new combinations. All of these in my mind, represent, unmet needs in, a relapsed refractory myeloma patient.