A phase 1 trial of arlocabtagene autoleucel, a GPRC5D-targeting CAR-T therapy, showed an 87% overall response rate and 53% complete response rate in heavily pretreated relapsed or refractory multiple myeloma patients. With a median duration of response of 18 months and a 1-year overall survival rate of 90%, these results are paving the way for larger phase 2 and 3 trials.
A new CAR-T cell therapy is turning heads in the multiple myeloma space. Arlocabtagene autoleucel, which targets the GPRC5D receptor, delivered impressive results in a phase 1 open-label, dose-escalation trial published in Blood. Among 84 heavily pretreated patients with relapsed or refractory multiple myeloma — all of whom had been exposed to three prior drug classes — the therapy showed deep and durable responses.
At a median follow-up of 16.1 months, the overall response rate hit 87%, with more than half of patients achieving a complete response. Progression-free survival and duration of response both clocked in at around 18 months, and 90% of patients were still alive at one year. While adverse events were common (100% experienced some grade), severe cytokine release syndrome and neurotoxicity remained relatively rare.
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Why it matters: These results support advancing arlocabtagene autoleucel into phase 2 (QUINTESSENTIAL) and phase 3 (QUINTESSENTIAL-2) trials, offering a potentially powerful new option for patients with few remaining treatment choices.
