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IMS 2026 | Efficacy and safety of cilta-cel in R/R MM: results from a PASS study
Hermann Einsele, MD, FRCP, University of Würzburg, Würzburg, Germany, discusses the results of a prospective, postauthorization safety study (PASS) on the efficacy and safety of ciltacabtagene autoleucel (cilta-cel) in patients with relapsed/refractory multiple myeloma (R/R MM), highlighting a good response rate and a favorable toxicity profile. Prof. Einsele notes that the study’s findings are consistent with the CARTITUDE-4 trial (NCT04181827), and suggests that CAR T-cell therapy is moving into earlier lines of therapy. This interview took place at the 23rd International Myeloma Society (IMS) Annual Meeting in Glasgow, UK.
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Transcript
This is a kind of study that we did prospectively in three different countries. So patients from Germany, Austria and Brazil were included. Most of the patients actually came from Germany. The vast majority of patients were being treated in earlier lines of therapy, so second, third line of therapy. And what we have seen is really a very nice response rate. We haven’t achieved the ones that were reported from CARTITUDE-4, but that’s probably due to the fact that the follow-up is rather short...
This is a kind of study that we did prospectively in three different countries. So patients from Germany, Austria and Brazil were included. Most of the patients actually came from Germany. The vast majority of patients were being treated in earlier lines of therapy, so second, third line of therapy. And what we have seen is really a very nice response rate. We haven’t achieved the ones that were reported from CARTITUDE-4, but that’s probably due to the fact that the follow-up is rather short. What is really reassuring is that the toxicity profile is not really different from CARTITUDE-4,. So we have a very low incidence of Parkinsonian-like syndrome. We have about 5% of patients developing cranial nerve palsy, which was easily manageable with steroids. And there are some additional strategies now under discussion on how to reduce the rate of delayed neurotoxicity and with an extremely low rate of immune effector cell-associated colitis. So, in summary, very good efficacy and a good safety profile of cilta-cel in this study. So, what we clearly see with CARTITUDE-4 and with the kind of approval of cilta-cel in second and third line therapy, CAR T-cell therapy has moved to earlier lines of therapy. And this is clearly improving the efficacy and also reducing toxicity, especially cytopenias are much less prominent. And also, as I indicated before, we see less Parkinsonian-like syndrome because obviously we have better bridging options. So I think with CARTITUDE-4, clearly cilta-cel is moving to earlier lines of therapy. And this is associated with a better efficacy and also a better safety profile.
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