ASH 2024 | Optimizing CD19 CAR T-cell delivery for patients with R/R aggressive lymphoma

We know by now that patients with lower disease burden and patients who have required less lines of therapy have better outcomes. This has been shown in the comparison of ZUMA-1, ZUMA-7, and ZUMA-12 moving from third line to second line to first line types of CAR therapy. And we know from looking at patients now who have participated both in TRANSFORM, the randomized trial of second line and liso-cel versus auto transplant, as well as ZUMA-7, the randomized trial of, again, axi-cel versus the alternative best supportive therapy, which is standard of care with an intent to go to transplant. We know that antigen density and disease burden both predict for better outcomes. So again, if you have higher amounts of 19, that’s been informative as published this past year by Fred Locke’s team. We know that the lower LDH, which is again surrogate for the amount of disease, is also a measurement of doing better. So if you intuitively step back and say what’s important, it’s important to get a patient from early either progression or refractory disease to the patient’s doctor that can offer a CAR T-cell in second line as quickly as possible to minimize the burden for insurance authorization. This is a FDA-approved therapy and Medicare, of course, will support this. And so reaching out to our referring docs and saying, you know, please call as soon as possible. And let’s discuss how to get them in within a week and get manufacturing done. And then think about it. Once you start the manufacturing process, you still have the obligate two to four weeks of manufacturing time, depending on who’s your manufacturer. Again, with Miltenyi, we have fresh in, fresh out, manufacturing in 11 days coming forward in cells. And this is Nirav Shah’s presentation of the bispecific 19-20. But on the other hand, some of the companies doing commercial products are still taking three, four weeks to deliver the products. Kite, and I’ll be presenting a poster based on Kite’s manufacturing changes here at this meeting, where they’re able to quickly move from a failed product into using the stored apheresis and go forward with now the greater than 90% of the patients getting these products back in 17 days. And again, time from brain to vein, time from the time you think the patient needs that therapy to getting it into the arm of the patient is really critical. So all these maneuvers are improving the patient’s experience and a lot of it still goes back to getting the patients educated, families enthusiastic support, and referring docs.

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