VIDEO: Understanding enrollment, racial disparities in DLBCL clinical trials

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This is such an important question. For every miracle we have in medicine, polio vaccines are a miracle. Again, I'll call CAR T-cells a miracle. Doing things that were previously just not imaginable. We have them only for of course, one reason. The reason is clinical research and patients choosing to go on trials. And really in in America overall we are not successful in getting enough patients on clinical trials. In some other countries they do a lot better than we do and therefore should be allowing advances to happen at a more rapid rate. There are a lot of reasons we don't do as well as we could. Hard to get into all of it. But overall the punchline is that for every patient we should be thinking about, "Would this patient potentially benefit from a clinical trial?" More practically speaking, in DLBCL, if a patient has one of the very lowest risk presentations of DLBCL, early stage, young and healthy, non BCL two expressing, low IPI, et cetera, there is an unmet need there but they have very high cure rates. Well above 60%, probably 70 and 80% like patients in the FLYER trial that are early stage disease and could get by with even less chemotherapy. So although we'd like to say every patient be considered for trial, certainly at least we are allowed to risk stratify.

And the patients with the most unmet need should have the greatest pressure to find trials as early as possible. Trials should not be, "We've tried everything for this patient and nothing works. So instead of hospice, let's send them to a clinical trial." That is not how to get patients the benefits of trials. We have frontline trials because they're still unmet need. If we're curing 60% of people, 40% of people have a huge unmet need. So we should be thinking about frontline DLBCL trials for every patient.

We just mentioned a Polaris trial showing real benefit for patients. We have lots of other things being studied in the frontline setting as well. One example, the group of medicines called bispecific antibodies which I honestly believe will be, and this is a very forward-looking statement, but will be the standard of care in five years from now, even in frontline DLBCL. That's a guess, but I think a reasonable one. We have BTK inhibitors being studied in the frontline And if we can increase that cure rate from 60% up to 70% or higher, that will be a huge impact and and benefit for our patients. So we need to be thinking about clinical trials for every patient towards that since most patients are cared for by community oncologists.

What we really need is academic oncologists who are very accessible by community oncologists. Meaning, you don't have to do a bunch of paperwork and fill out a bunch of faxes. If faxing is still a thing, I'm not sure, but you should have the cell phone of some nearby academic lymphoma doc that you know you trust and they give you the quick, easy, timely answers. You have your cell phone, you call them and they talk to you right away so that we can get the patients that really would benefit from trials quickly onto trials. Because DLBCL frontline therapy is a time sensitive thing. You can't wait around two months to do some screening for for a clinical trial. So we need the optimal networking, interaction, communication, between community oncologists and academic oncologists. So that's partly on the academic oncologist to make themselves accessible. So very important.

And there's always been a question of whether racial bias impacts clinical research and trial enrollment. Certainly clinical trials enroll in sort of geographically focal ways. They enroll where the biggest most prolific academic centers are. Sometimes those are in centers with totally one group of racially biased enrollee are eligible for the trial. We are very lucky here in New York to have a profoundly diverse group of patients here in Mount Sinai. We are literally on the border of Upper East Side Spanish Harlem and Harlem. So we've been very fortunate to get lots of patients even with sort of geographically unique types of lymphoma. One type called ATLL which only shows up in the Caribbean, certain parts of East Asia and places that have a lot of immigrants from both of those places like New York. But it's certainly something we have to be wary of because if every patient on a trial was of one ethnicity or gender or color or creed, then we'd have to be careful how we apply those results to every other derivation. So we need to aim for avoiding racial bias in clinical trial enrollments and some of these centers we've been very fortunate to be able to do so.