The risk of subsequent malignancy has recently emerged after the addition of the FDA black box warning for CAR-T products, which resulted from the cases of T-cell lymphomas that were seen after the CAR T-cell therapy. And in some of those cases, the CAR transgene was identified in the malignant cells, suggesting that there is a potential link.
We retrospectively looked at 355 patients with relapsed/refractory B-cell lymphomas that had received CD19-targeted CAR T-cell products between 2016 and 2022...
The risk of subsequent malignancy has recently emerged after the addition of the FDA black box warning for CAR-T products, which resulted from the cases of T-cell lymphomas that were seen after the CAR T-cell therapy. And in some of those cases, the CAR transgene was identified in the malignant cells, suggesting that there is a potential link.
We retrospectively looked at 355 patients with relapsed/refractory B-cell lymphomas that had received CD19-targeted CAR T-cell products between 2016 and 2022. And in this retrospective study, the cumulative incidence of subsequent malignancies at 36 months was 6% for solid tumors, and 4.5% for hematologic malignancies, which is relatively similar to the rate that is observed with other cancer treatments. We didn’t observe any cases of T-cell malignancies, and the only significant factor associated with subsequent malignancy was older age, basically. And most of the non-relapse deaths in our report were due to infection.
So, the overall CAR-T therapy seems to be relatively low risk for, you know, I mean, relatively low or similar risk for potentially subsequent malignancies as other cancer treatments. So, you know, the benefits of CAR T-cells continue to outweigh their risks. Because there is this potential risk of CAR T-cells, actually, nowadays, we should follow up patients and screen them for subsequent malignancies lifelong, basically.
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