As I had assumed, now that the ASCO meeting is happening, I'm seeing more press releases and articles (and soon, some videos, I'm sure) about some of the presentations. I'll look at several over the next few weeks, but I thought this one was really interesting. Keep in mind, though, that it is a very small study and only one Follicular Lymphoma patient was included.
If you've been following FL research for even a short time, you know about CAR-T. In this treatment, a patient had T cells removed from their blood and brought to a special laboratory. T cells are a type of immune cell. The immune system can't recognize cancer cells as something that doesn't belong there, so the T cells are changed in the lab so they do recognize the cancer cells. It can be a very effective treatment for many patients. (I wrote about the whole behind-the-scenes process last month.)
One big problem with CAR-T is that it can be very expensive. I haven't seen any recent figures, but a few years ago, the cost was close to a half million US dollars. Which really isn't surprising, since each patient is basically getting a treatment made just for them.
So one of the problems that newer versions of CAR-T are being created are trying to solve is how to bring the cost down. And one way of doing that is to create an "allogeneic" version -- one that uses someone else's T cells, so that one sample of cells can be grown and grown and used for many patients. It would create an "off-the-self" version of CAR-T.
This presentation discusses research that is attempting to do that. The specific CAR-T is called Azercabtagene Zapreleucel, or Azer-cel. The study is a phase 1b dose escalation clinical trial. Phase 1 studies are usually small, and the focus is on safety -- figuring out how much of a treatment will be effective before it starts to do more harm than good. That's what "dose escalation" means -- they increase the dose until they find out how much is too much.
This study involves only 19 patients with many different subtypes of Lymphoma. Five had Diffuse Large B-cell Lymphoma, five had Marginal Zone Lymphoma (MZL), four had CLL/Small Lymphocytic Lymphoma, three had Primary Central Nervous System Lymphoma (PCNSL), one had Waldenstrom Macroglobulinemia (WM), and one had Follicular Lymphoma. All of them had Relapsed/Refractory disease, so they had received at least one prior treatment.
The results were good, with 81% (13 of 16 who were evaluated) of the patients having a response, including 31% (5 of 16) achieving a Complete Response. The FL patient was one of the 5 who had a CR.
Phase 1 trials are usually focused on safety, though the abstract didn't give too much information about safety. ICANS occurred in 7 patients (37%), with 3 Grade 1-2 events, 3 Grade 3 events, and 1 Grade 4 event. ICANS stands for Immune Effector Cell-Associated Neurotoxicity Syndrome, where immune cells can cross into the brain. Higher grade ICANS can be very serious. Another common side effect of CAR-T, Cytokine Release Syndrome, occurred in 79% of the patients (15 of them), though there were no grade 3 or grade 4 events.
The researchers conclusion is that Azer-cel is worth studying further, given that it was effective in multiple sub-types of Lymphoma, and the side effects were manageable.
An off-the-shelf CAR-T would indeed be a very exciting new treatment. It's very early -- years from Azer-cel making it to the doctor's office -- and only 1 FL patient has been involved so far in the study. But this isn't the only off-the-shelf CAR-T being developed, and we might very well be moving closer to this being a reality.
More ASCO stuff soon.
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