https://orcid.org/0000-0001-7369-8612
Key Points
At approximately 5 years follow-up, objective response rate with zevor-cel was 100% and 78.6% patients achieved complete response/better.
No grade 3 or higher CRS or any grade neurotoxicity or other delayed significant adverse events were observed with zevor-cel.
Patients with relapsed/refractory multiple myeloma (RRMM) frequently develop drug resistance, ultimately leading to poor survival outcomes. Zevorcabtagene autoleucel (zevor-cel or CT053) is a fully human BCMA targeting CAR T 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. Patients with RRMM who received ≥ 3 prior regimens were enrolled. Safety, tolerability, efficacy, and pharmacokinetics were evaluated. Fourteen patients (50% male) received a single infusion of zevor-cel (100×106 [N=3] and 150×106 CAR T cells [N=11]). As of February 22, 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 was observed. There were three deaths, and none was zevor-cel-related. The objective response rate was 100% (95% 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 one (7.1%) with partial response. The median duration of response was 24.94 (95% CI; 14.03 ̶ 45.86) months. 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 post-infusion, the overall survival rates were 100%, 92.3%, 84.6%, and 76.9%, respectively. This 53.3-months median follow-up data of zevor-cel reaffirms the initial results with a manageable safety profile and compelling efficacy in RRMM. NCT03975907
