CAR T-cells have revolutionized the field of hematology. However, there has been an alert from the FDA because of an emergence of cases of T-cell malignancies after CAR T-cell therapy. Therefore, we wanted to assess the real-life incidence of these T-cell malignancies. And we used the DESCAR-T registry, which is a French registry of all cases of commercial CAR T-cell used in France for B-cell lymphoma, multiple myeloma, and B-cell acute leukemia...
CAR T-cells have revolutionized the field of hematology. However, there has been an alert from the FDA because of an emergence of cases of T-cell malignancies after CAR T-cell therapy. Therefore, we wanted to assess the real-life incidence of these T-cell malignancies. And we used the DESCAR-T registry, which is a French registry of all cases of commercial CAR T-cell used in France for B-cell lymphoma, multiple myeloma, and B-cell acute leukemia.
So what we see with that registry, looking at over 3,000 patients, is that there was only one case of T-cell malignancy, which means a risk of 0.03% of T-cell malignancy after CAR T-cells. This is reassuring for the patients.
And I want to highlight that this data is strong in the way that with this registry we have a true denominator as we have all cases of CAR-T therapy in France during a six-year period of time. However, we still need longer follow-up and also we still need to better understand the complex mechanisms that can lead to the development of T-cell malignancy. But the final message is that so far it is reassuring, especially when you weigh the benefits and the risks of the therapy. Yes, there is a risk, but if you don’t receive CAR-T when the disease is at high risk, unfortunately, there is a high risk of mortality. So on this balance of benefit and risk, the studies show that there is a stronger benefit of using CAR T-cells.
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