zevor-cel 治疗复发/难治性多发性骨髓瘤患者的长期随访

Patients with relapsed/refractory multiple myeloma (RRMM) frequently develop drug resistance, leading to poor survival outcomes. Zevorcabtagene autoleucel (zevor-cel or CT053) is a fully human B-cell maturation antigen, targeting chimeric antigen receptor (CAR) T-cell therapy for patients with RRMM. The phase 1 part of LUMMICAR study 1 was a single-arm, open-label, multi-center study conducted in China, enrolling patients with RRMM who received 3 prior regimens. Safety, tolerability, efficacy, and pharmacokinetics were evaluated. Fourteen patients (50% male) received single infusion of zevor-cel (100 106 [n = 3] and 150 106 CAR T cells [n = 11]). As of 22 February 2025, with the median follow-up duration of 53. 3 months (range, 14. 8-63. 5), 13 (92. 9%) patients experienced grade 1 or 2 cytokine release syndrome.

No immune effector cell-associated neurotoxicity syndrome, delayed neurotoxicities, second primary malignancy, or other delayed adverse events were observed. There were 3 deaths, and none were zevor-cel-related. The objective response rate was 100% (95% confidence interval [CI], 76. 8-100. 0) and 11 (78. 6%) patients achieved complete response or better, 13 (92. 9%) with very good partial response or better response and 1 (7. 1%) with partial response. The median duration of response was 24.

94 months (95% CI, 14. 03-45. 86). The proportion of patients with a response lasting 36 months and 48 months were 41. 7% and 15. 6%, respectively. At 24, 36, 48, and 60 months after infusion, overall survival rates were 100%, 92. 3%, 84. 6%, and 76. 9%, respectively. This 53. 3-month median follow-up data of zevor-cel reaffirms the initial results with a manageable safety profile and compelling efficacy in RRMM. This trial was registered at www. clinicaltrials. gov (NCT03975907).