ASH 2024 | NGS-MRD is predictive of PFS in patients with R/R ALL treated with brexu-cel

So in ALL treatments, in NGS-MRD negativity is one of the key prognostic markers, especially more important in the frontline setting where they’re highly associated with better survival in those patients who may be able to omit a consolidative allogeneic transplant. We wanted to look at the prognostic significance of NGS-MRD negativity in the setting of CAR T-cell therapy, in this case brexu-cel, in the real-world data registry. Initially, we set out to answer the question whether these patients may not need a follow-up or a transplant after receiving CAR-T cell therapy. However, we realized the numbers are a little bit too small for us to reach that definitive conclusion. However, we did find that NGS-MRD negativity at day 28, as expected, predicts a better progression-free survival for these patients. So I think this study in combination with other prior studies in pediatric ALL with tisagenlecleucell in real-world data that NGS-MRD negativity is an important prognostic marker both at day 28 and month three which probably be another time point that is critical for us to know how these patients do. So NGS-MRD positive, if you have any level of detectable disease, these patients will be, you know, worrisome to the degree of progression in the future. So these will be the patients that will be in heightened alert or thinking of consolidative treatment or more proactive therapy, including bone marrow transplant and maybe some other immunomodulatory agents or maintenance therapy. But MRD-negative patients, however, especially if they had a low disease burden at the beginning, might be the patients that we may think about holding off on bone marrow transplant and just follow these patients with subsequent close monitoring of NGS MRD negativity. Our abstract unfortunately did not answer the question whether we could hold off on the transplant, but it does suggest that if any patients, it will be in that group. On the flip side, again, NGS-MRD positive patients are the ones that we want to do more. And a similar study was also presented in the context of obe-cel, another CD19 CAR-T therapy with a very similar result of a prognostic value of NGS-MRD negativity in both of the patient groups.

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