ASH 2023 | The risk of T-cell malignancies associated with CAR T-cell therapy

There’s an FDA announcement that just came out very recently, in the last couple of weeks, about reports of T-cell lymphomas across both CD19 CAR-T and BCMA-targeted CAR-T, and this includes reports from clinical trial and real-world post-marketing reports. We are still waiting for more details of these reports from the FDA, particularly in terms of how many of these T-cell lymphomas are CAR-positive versus CAR-negative because they infer different risks, you know, are these from CAR insertion that somehow is driving a lymphoma process versus a secondary malignancy that we can see across many, many different types of treatment for cancer. At this time, given that the FDA has received reports from over 34,000 patients who received CAR-T treatment and we’re seeing 12 cases, the incidence is very, very low. So, we do not have enough information to say this is so concerning that we would change the way that we screen patients for eligibility or consider them for CAR-T. I think we need more information from the FDA to understand that. And overall, with both CD19 and BCMA-targeted CAR-T, because of the strong response rate and long, you know, remission-free or PFS period with these products, the benefit still outweighs the potential risk. So we are informing patients about these, you know, evolving pieces of information as we get them to help them make informed decisions. We do have ways of monitoring and screening for these if there are any clinical concerns for them. But it’s not to the point where we have enough information to say this is changing the way we select patients or manage them post-CAR-T.