Cytopenias Are ‘Limited’ Following Ide-Cel in R/R Multiple Myeloma
The safety profile of idecabtagene vicleucel in relapsed/refractory multiple myeloma following the first 3 months of treatment appears to be comparable with standard therapies, says Rachid Baz, MD.
During the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition, Rachid Baz, MD, spoke with CancerNetwork® about how safety data from the phase 3 KarMMa-3 trial (NCT03651128) showed a low rate of cytopenias and infections with idecabtagene vicleucel (ide-cel; Abecma) as a therapy for patients with relapsed/refractory multiple myeloma.
According to Baz, the Myeloma Section head in the Department of Malignant Hematology at Moffitt Cancer Center and co-director of the Pentecost Family Myeloma Research Center, safety signals in the KarMMa-3 trial were expected based on results from a prior assessment of ide-cel in relapsed/refractory multiple myeloma in the phase 2 KarMMa-1 trial (NCT03361748). Additionally, cytopenias and infections generally occurred early during treatment, and the overall safety profile of ide-cel following the first 3 months of therapy appeared to be comparable with standard multiple myeloma treatment options.
Data from the KarMMa-3 trial highlighted that the rates of grade 3/4 cytopenias with ide-cel were 87.1% at fewer than 3 months, 24.1% at more than 3 and fewer than 6 months, and 14.7% at more than 6 months compared with standard regimens. Cytopenias in the ide-cel arm were typically managed with colony-stimulating factor (55.5%), red blood cell transfusions (48.0%), and platelet transfusions (32.0%).
Transcript:
The main implication is that there was not a signal [in KarMMa-3] that we did not anticipate from the KarMMa-1 study. Cytopenias are something hematologists are usually comfortable managing or something comfortable for us to deal with. I typically use growth factor support and transfusion support when needed. It is very rare that patients require things like a stem cell boost. That’s our experience with CAR T so far.
In that specific patient population, we saw that the reassuring part is that a lot of this [toxicity] was limited. We saw it mostly in the first 3 months of treatment.The same was true for infection. When you look at bacterial infection, they were more common in the first 3 months of treatment. Beyond the first 3 months, the rate was not very different than what you would see in a patient population receiving a [standard] myeloma therapy.
Reference
Baz R, Otero PR, Ailawadhi S, et al. Idecabtagene vicleucel (ide-cel) versus standard (std) regimens in patients (pts) with triple-class-exposed (TCE) relapsed and refractory multiple myeloma (RRMM): analysis of cytopenias and infections in pts from KarMMa-3. Blood. 2023;1429(suppl 1):4879. doi:10.1182/blood-2023-174477
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