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Five-year follow-up results from the phase I part of the open-label, multicenter, LUMMICAR STUDY 1 (NCT03975907), evaluating zevorcabtagene autoleucel (zevor-cel), a fully human B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy, for the treatment of patients with relapsed/refractory multiple myeloma (RRMM) and ≥3 prior lines of therapy (LoT), were published in Blood Advances by Fu et al. Data from 14 patients were included in this follow-up. The primary endpoint was safety and tolerability of zevor‑cel within 28 days of infusion. Secondary endpoints included safety, tolerability, efficacy, and pharmacokinetics (PK) of zevor‑cel after infusion.
Key data: At a median follow-up of 53.3 months (range, 14.8–63.5), 92.9% of patients experienced Grade 1/2 cytokine release syndrome (CRS), with no reports of higher-grade CRS, immune effector-cell associated neurotoxicity syndrome (ICANS), delayed neurotoxicity, second primary malignancy, or other delayed adverse events (AEs). There were no dose-limiting toxicities (DLTs) observed; however, Grade 3/4 treatment-emergent AEs (TEAEs) were reported in 100% of patients. The objective response rate was 100% (95% confidence interval [CI], 76.8–100.0), with 78.6% being a complete response or better. The median duration of response (DoR) was 24.94 months (95% CI, 14.03–45.86), with overall survival (OS) rates of 100%, 92.3%, 84.6%, and 76.9% at 24, 36, 48, and 60 months post-infusion, respectively.
Key learning: Five-year follow-up results demonstrate durable efficacy of zevor‑cel in patients with RRMM, supporting its continued evaluation in ongoing clinical studies.
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