Cytopenias Are ‘Limited’ Following Ide-Cel in R/R Multiple Myeloma

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