IMS 2025 | The Phase III Quintessential-2 trial of arlo-cel versus SoC in myeloma: trial in progress

The Quintessential-2 Phase III clinical trial is currently enrolling worldwide. This is a study investigating a new CAR T-cell known as arlo-cel. Arlo-cel is a CAR T-cell that targets GPRC5D. So this is very important as it is a non-BCMA target now that we’re all used to using BCMA targeted agents and we anticipate that these agents will be available as first-line treatment very soon in the future. So this targets GPRC5D, which is the same target as talquetamab, and in Phase I clinical trials has shown very good efficacy with response rates of over 90% in BCMA-naive patients and a slightly lower response rate in BCMA-exposed patients. We can see that patients do appear to have a durable response. We’re still waiting on what the median progression-free survival is, but it does appear to be quite durable. And in terms of the toxicity profile, whilst it does target GPRC5D, the side effect profile in terms of skin, oral and nail toxicities appear to be lower. There is, however, a low incidence of cerebellar dysfunction. So the Phase I and Phase II clinical trials are running, but it’s very important that we compare arlo-cel with standard of care. And that is the Quintessential-2 study which is comparing a single infusion of arlo-cel to standard of care, namely daratumumab, pomalidomide and dexamethasone or carfilzomib and dexamethasone for patients who’ve had one to three prior lines of therapy and have been exposed to lenalidomide. This study is currently enrolling worldwide and we anticipate that it will continue to enroll for at least another year.

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