IMS 2025 | Safety and efficacy of cilta-cel in RRMM: a CIBMTR study

So this was a study from the CIBMTR, the largest cohort reporting on standard of care cilta-cel, so nearly 600 patients. What we saw is that majority, 70% of these patients, had clinically significant comorbidities, about 30% had higher-risk cytogenetics. We had about 10% that had prior BCMA exposure. From a safety perspective, we saw that grade three or higher CRS and ICANS occurred in about 4% of the patients each. The non-ICANS neurotoxicities occurred in about 6%, so about 3% had nerve palsy, such as facial palsy, and another 3% had Parkinsonism. Treatment-related mortality, about 5%. From a response standpoint, best response rate, 87%. Very good partial response rate, 75%. 12-month PFS and OS rate, 73 and 85%, respectively. In terms of identifying who are the patients that are most likely to experience, for example, grade 2 or higher CRS or any grade ICANS. Generally, these tended to be patients who are older, who have comorbidities and have a higher disease burden or plasma cell burden prior to CAR-T. In terms of progression-free survival, we saw that patients who had prior BCMA exposure, high-risk cytogenetics, poor ECOG, high plasma cell burden, elevated lactate dehydrogenase and ferritin were independent adverse prognostic factors. So generally speaking, I think our study was consistent with what we have previously seen. It does show that safety and efficacy of cilta-cel is favorable and does support its use in clinical practice despite patient heterogeneity and high prevalence of clinically significant comorbidities. And as mentioned, this is the largest cohort of 600 patients from the Center for International Blood and Marrow Transplant Research.

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