EBMT 2022 | Tolerability of CAR-T therapies in clinical trials and in the real-world
Marion Subklewe, MD, Ludwig-Maximilians-University of Munich, Munich, Germany, compares the toxicity of different chimeric antigen receptor T-cell (CAR-T) products in pivotal clinical trials and in the real-world setting. Overall, data from the real-world shows that CAR-T products are less toxic than in clinical trials. Dr Subklewe explains that the management of CAR-T-related side effects in clinical practice is improving, and data is suggesting that the inclusion criteria from pivotal trials is not entirely relevant in the real-world. Lastly, Dr Subklewe comments on the different toxicity profiles of available CAR-T therapies, highlighting the importance of determining which product is the most appropriate for each patient. This interview took place at the 48th Annual Meeting of the European Group for Blood and Marrow Transplantation (EBMT) 2022, which was held virtually.
Transcript (edited for clarity)
I think there are clear differences between the different products and we have the data from the pivotal trials and the real-world data. So I think for all products, one can say, almost surprisingly, that the real-world evidence data is showing less toxicity than the results from the pivotal trials, and as I already said, I think there are two things that are contributing or that are relevant to notice...
I think there are clear differences between the different products and we have the data from the pivotal trials and the real-world data. So I think for all products, one can say, almost surprisingly, that the real-world evidence data is showing less toxicity than the results from the pivotal trials, and as I already said, I think there are two things that are contributing or that are relevant to notice.
First of all, with growing experience, we are better in interventions and thereby intervening early so that no higher grade or severe side effects are occurring. And second, what it also shows us, is that the inclusion and exclusion criteria of the patients are not that relevant and are not contributing in the same extent to the development of toxicities. We know that in the real-world setting, only 30-60%, depending on the group that is reporting, are actually fulfilling the inclusion criteria of the corresponding pivotal trial. So, we know that these are not risk factors for development of CRS, ICANS, or also hemotoxicity. The other aspect is that the different products vary in their toxicity profile, and I think we have to counterbalance this with efficacy and we will need further data to know which product is most suitable for each individual patient looking at response rate, but also toxicity.
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