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EBMT 2026 | Toxicity-free PFS and CR as potential novel composite endpoints after CAR T-cell therapy for LBCL
Veronika Bachanova, MD, PhD, University of Minnesota, Minneapolis, MN, discusses the concept of toxicity-free progression-free survival and toxicity-free complete response at day 100 after CAR T-cell infusion (tfPFS100 and tfCR100, respectively) as novel composite endpoints in large B-cell lymphoma (LBCL), highlighting their potential to better reflect patient outcomes by considering both progression and toxicity. Prof. Bachanova explains that these endpoints can help compare the efficacy and safety of different CAR T-cell products and may be particularly useful for benchmarking existing products against future novel therapies. This interview took place at the 52nd Annual Meeting of the EBMT in Madrid, Spain.
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Transcript
So we think the current standard endpoints do not fully reflect the optimal outcome and there may be some room to really better define what we want, which is the patients in remission and free of toxicities. So we sought to develop or to propose novel composite outcomes. One of them is progression-free survival at day 100 without toxicity, so-called toxicity-free, progression-free survival at day 100...
So we think the current standard endpoints do not fully reflect the optimal outcome and there may be some room to really better define what we want, which is the patients in remission and free of toxicities. So we sought to develop or to propose novel composite outcomes. One of them is progression-free survival at day 100 without toxicity, so-called toxicity-free, progression-free survival at day 100. It’s a very early time point when the patients are free of progression, free of the grade 3 CRS and grade 3 ICANS, and that was found to be about 50% in the entire cohort, but very different by different products.
Then we went on and each patient was assigned a new endpoint at day 100 called either toxicity-free CR, CR with toxicity, or the other patients were non-responders or the patients who either had progression or died were in a non-responders group. And so those groups were then compared for the standard PFS and OS in a subsequent analysis and also by the product. And we found quite interesting insights into integration of the safety and toxicity for different products. And we think that the most utility of these new endpoints is for benchmarking and comparing the existing products to novel future products, such as allogeneic CAR, in vivo CAR, additional bispecific CARs, and a new cell therapy product, which should be compared to the autologous CAR-T, which we currently use.
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