Ide-Cel and Lenalidomide Maintenance in MM Following Suboptimal ASCT Response
Alfred L. Garfall, MD, MS, discussed data from the phase 2 BMT CTN 1902 trial.
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Garfell went over the key efficacy and safety data presented. Notably, the
CGTLive: Can you discuss the efficacy results presented from the BMT CTN 1902 clinical trial?
Alfred L. Garfall, MD, MS: We wanted an end point that would read out relatively quickly and give us an initial sense of the efficacy and so the primary end point was improvement of the response to a CR 6 months after the CAR T-cell infusion. We know at this stage in patients' therapy, if you're not on a CR at this point, it's pretty unlikely that you evolve to CR spontaneously over 6 months. It doesn't happen that often, but we kind of projected from prior data that it would happen less than 10% of the time spontaneously. So we set a bar for ourselves to see if we could increase that to at least 30% and what we found actually was that we did even better than that by a good amount: 63% of patients converted to CR and another 24% upgraded their response in some other way—a total of 87% of patients improved their response to some extent.
Can you discuss the safety data presented?
It was very encouraging. We did see a high rate of cytokine release syndrome (CRS)—81% of patients overall developed CRS. That's in some ways reassuring, because the CAR T-cells are getting in there and expanding in vivo, even though there's not a lot of myeloma around to stimulate them—but all the CRS was low grade, grade 1 or 2, with most of them being grade 1 events.
Also reassuringly, we saw immune effector cell-associated neurotoxicity syndrome or neurologic toxicity at all, which is really encouraging. I think this supports the safety of this approach, giving CAR T-cells in a consolidation setting or with a lower disease burden—this isn't a comparative study, but it seems to [have] a more favorable side effect profile than what we see in the relapse setting.
This transcript has been edited for clarity.
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