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    Cellular and T cell engager Immunotherapy

    Category: Cellular and T cell engager Immunotherapy

    Long-term Follow-Up of a Phase 1 Study of Arlocabtagene Autoleucel (arlo-cel; BMS-986393) in Patients With Heavily Pretreated Relapsed/Refractory Multiple Myeloma (RRMM)

    (PA-076) Long-term Follow-Up of a Phase 1 Study of Arlocabtagene Autoleucel (arlo-cel; BMS-986393) in Patients With Heavily Pretreated Relapsed/Refractory Multiple Myeloma (RRMM)

    Wednesday, September 17, 2025
    • JB

      Jesus G. Berdeja

      Director of Multiple Myeloma Research
      Sarah Cannon Research Institute and Tennessee Oncology

    Introduction: Arlo-cel is a chimeric antigen receptor (CAR) T-cell therapy targeting G protein-coupled receptor class C group 5 member D (GPRC5D), a validated target in RRMM. Previously reported results (23Aug2024 cutoff) from this multicohort, dose escalation phase 1 study (NCT04674813) in pts with RRMM demonstrated deep, durable responses across doses, including the 150×106 dose, which was identified as the recommended phase 2 dose (RP2D) currently being used in the ongoing phase 2 QUINTESSENTIAL study. Herein we report the longer-term follow up of this phase 1 study for the 75×106 and the 150×106 cohorts – the 2 dose-expansion cohorts with patients that have not yet reached end-of-study follow up. The 25×106, 300×106, and 450×106 dose cohorts have completed follow up and were previously reported.

    Methods: We enrolled pts with RRMM who received ≥3 prior lines of treatment, including a PI, an IMiD™, and anti-CD38 therapy. Following lymphodepletion, arlo-cel was administered as a single infusion of 25×106–450×106 CAR+ T-cells. The primary objective was to demonstrate safety; secondary objectives included to demonstrate clinical activity (assessed per IMWG Uniform Response Criteria) and describe pharmacokinetics. The data cutoff date was 4April2025.

    Results: Of 86 enrolled pts, 84 (98%) received arlo-cel, of whom 24 received the 75×106 dose and 26 who received the 150×106 dose.  Baseline characteristics were similar across dose levels. Median age was 63 years, 51% were male, and 44% had high-risk cytogenetics; pts had a median of 5 prior regimens. In these 2 cohorts, respectively, treatment-related grade G3/4 AEs were 75% and 69%. Cytokine release syndrome (CRS) rates were 75% and 88%, and 1 patient in each cohort experienced G1 immune effector cell-associated neurotoxicity syndrome (ICANS). CRS events were all G1/2 and resolved; both ICANS events resolved. Rates of on-target/off-tumor (OTOT) nail, skin and oral TEAEs were similar at the 2 dose levels; all were G1/2.

    Median follow up for efficacy evaluable pts in the 75×106 and 150×106 cohorts was 19.9 mo (range, 3.8–27.5) and 24.0 mo (range, 4.6–25.8), respectively. Efficacy outcomes were similar, including overall response rate (92% vs 91%), complete response rate (58% vs 43%), and median (95% CI) duration of response (16.4 mo [11.1, NA] vs 13.6 mo [5.3, NA]).  Additionally, for these two dose cohorts, similarities were observed in clearance of sBCMA and in MRD negative CR rates (46% vs 41%).


    Conclusions: Maturing data from the phase 1 study demonstrate a safety profile consistent with previous disclosures and deep and durable responses following a single infusion of arlo-cel. These data, demonstrating comparable efficacy between 75×106 and 150×106 doses of arlo-cel, suggest that both doses have a favorable benefit-risk profile in RRMM.