Joseph Mikhael, MD, MEd, FRCPC, FACP, chief medical officer of the International Myeloma Foundation, discussed the manufacturing challenges sometimes seen with chimeric antigen receptor (CAR) T-cell therapies and strategies being implemented to improve access for historically underserved patients.
Joseph Mikhael, MD, MEd, FRCPC, FACP, chief medical officer of the International Myeloma Foundation, discussed the manufacturing challenges sometimes seen with chimeric antigen receptor (CAR) T-cell therapies and strategies being implemented to improve access for historically underserved patients with multiple myeloma (MM).
In light of the manufacturing challenges sometimes seen with CAR T-cell therapies for MM, what considerations should be taken into account when selecting a therapy among CAR T, bispecifics, or other options?
There's no doubt that there is still an access challenge, [and] that access challenge is multi-fold. Some of it has to do with manufacturing, some of it has to do with geography. And, sadly, a lot of it has to do with race and ethnicity, and socioeconomic status, as we've seen, tragically, that there are many individuals who simply do not have access to some of these novel therapies, namely CAR T-cell therapy and bispecifics.
I think a lot of these challenges are being addressed head on—we are seeing greater manufacturing opportunities and more sites opening, we are recognizing, I think, a reality of the disparity that there is in access and how we can look at overcoming it. But all the while, whenever there is reduced access to any phenomenon in medicine, and particularly in cancer care, we want to make sure that the the right patient is being treated with the right therapy at the right time. And part of the challenge is that we really don't know the right sequence yet. Is it better to do it bispecific than a CAR T or vice versa? And so right now, very often, it's whatever is available. The best one available, obviously, is the best one to use because it is the only one available. But I do see that this is a challenge right now, especially across the diversity of the United States and really the world. But I do think that we are trying to more strategically address the issue so that we can have choice, because there are some patients that are simply not going to be eligible for a CAR T-cell therapy who may be eligible for biospecifics—and, frankly, vice versa.
The beauty of these different treatments is that they have different approaches to therapy. Some require more hospitalization or less hospitalization, or can be given in older, more frail patients [that] others may not be. Ultimately, we want to be able to match the right treatment to the right patient. And in the interim, we're trying to prioritize in a way that recognizes the severity of one's disease, but also recognizes that we want to optimize the efficacy of these agents.
Are there any alternative strategies being explored to improve the manufacturing process and accessibility of CAR T-cell therapies for MM?
Everything is on the table with increasing access to CAR T-cell therapy. I think there is a move from the manufacturers themselves, from the academic centers, from the community, from regulatory agencies. I mean, I think everyone recognizes that this is a therapy that can have a tremendous impact, but it's not going to have an impact if people don't have access to it.
I think we're also realistic that this is not a problem that can just easily be solved overnight. This is a complex treatment that requires highly sophisticated centers that can collect T cells, that can then manufacture those T cells, [and] that can then reinfuse them. I'm by no means admitting that there should be such a disparity, but at the same time, I think we have to recognize that if we want to do it, we need to do it correctly.
Various strategies are being looked at. There are increased capacity in the places where they're being manufactured that are now being expanded. There are more sites that are being activated to be able to deliver CAR T-cell therapy, and there's a strong push to ensure that those sites are also ones that are perhaps historically in areas where patients did not have as good access in more rural areas where there is still the excellence required and the standard required to both collect and deliver T cells—but areas that geographically would be in greater proximity to where many patients with multiple myeloma live.