IMS 2025 | Efficacy and safety of arlo-cel in RRMM with 1-3 prior lines of therapy: Phase I results

So at this meeting we’re giving an update of the Phase I study of arlo-cell which is the GPRC5D CAR T-cell therapy in patients that have had one to three prior lines of therapy. So this was a cohort in the original Phase I trial that studied arlo-cel and earlier lines of therapy in patients that were less pretreated or heavily pretreated than the three prior line cohort that was presented earlier today. So in this study, in this cohort, we enrolled 31 patients that had one to three prior lines of therapy. All of these patients were refractory to an immunomodulatory drug and a proteasome inhibitor. And despite the average being about two lines of therapy in this cohort, 71% of patients had prior exposure to CD38 monoclonal antibodies, reflecting that this was still a fairly heavily pretreated patient population, despite it being an earlier line cohort. So in this study, the median age was in the low 60s. The prior lines of therapy were equally distributed between one, two, and three prior lines, so about a third each in each of those cohorts. And approximately 30% of patients had extramedullary disease and a fair bit of patients had high-risk cytogenetics. So again, reflecting a more higher risk patient population. In terms of safety, we saw hematologic toxicity as we would expect. So the neutropenia rates were around 80%. Same thing with the rates of thrombocytopenia and anemia. They were obviously lower, but most of those were transient. And then we see GPRC5D-related toxicities as expected with this agent. So dyskinesia was seen in about a third of patients. And again, very much transient compared to what we see with the bispecific antibodies with the same target. CRS was seen in about 84% of patients. No patients had high-grade CRS. There were no grade five treatment-related deaths on this study. There were two patients that had these other select neurotoxicities, which is ataxia, dizziness syndrome at the time of the data cutoff. And the median follow-up right now for the trial is 18 months. And the overall response rate was 94%, with 71% of patients having a complete response to therapy. The median progression-free survival is not yet mature, but at the 12-month mark, over three-quarters of patients were still progression-free in this high-risk cohort. So overall encouraging efficacy, you know, again in the earlier line cohort compared to what we have seen before in the late line patients.

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