Joaquín Martínez López (EN)

The regulatory agencies for medicines in the United States and Europe have issued statements informing about a possible risk of developing certain types of tumors following CAR-T cell immunotherapy treatment. What do we know so far? What is the real risk? Does the benefit-risk balance still hold? Has anything changed after these alerts? We answer these questions with expert opinions and the data currently available. 

Cancer immunotherapy, and in particular the so-called checkpoint inhibitors, have improved the prognosis of several types of tumours. However, they are not effective in everyone. Two early-stage clinical trials have tested the addition of a type of immunomodulator to this therapy in patients with lung cancer and Hodgkin's lymphoma, with apparent good results. The results are published in the journal Science.  

CAR-T cell therapies may, in some cases, produce tumours secondary to treatment. A few months ago, the US Food and Drug Administration (FDA) said it was assessing this risk. Now, a study conducted at Stanford University Medical Center (USA) has tracked 724 patients who received this type of treatment since 2016. Of these, 14 developed another blood tumour, but only one was a T-cell lymphoma that could be a direct consequence of the therapy. Further analysis ruled out this link. The results are published in the journal NEJM.