Cellular and T cell engager Immunotherapy

Category: Cellular and T cell engager Immunotherapy

Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma

(PA-029) Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma

Friday, September 19, 2025

Chengcheng FU

Chief Physician
The First Affiliated Hospital of Soochow University, Suzhou, PRC

Introduction: Zevorcabtagene autoleucel (zevor-cel) is a B-cell maturation antigen (BCMA) targeting, fully human, autologous, chimeric antigen receptor (CAR) T-cell therapy which has been approved in China since 2024 for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Herein, we present the updated results from Phase 1b of LUMMICAR STUDY 1 evaluating the safety and efficacy of zevor-cel in 14 patients.

Methods: This was a single-arm, open-label study conducted at five sites in China (NCT03975907). Patients with RRMM who had received ≥ 3 prior regimens including a proteasome inhibitor and an immunomodulatory agent with an eastern cooperative oncology group (ECOG) score of 0 or 1 were enrolled. Zevor-cel was administered as a single infusion of 100 × 10⁶ or 150 × 10⁶ CAR⁺ T cells.

Results: Between July 23, 2019 and July 10, 2020, 14 patients (50% male) with a median age of 54 years (range:34, 62), received a single infusion of zevor-cel (100 × 10⁶ CAR⁺ T cells in 3 patients, 150 × 10⁶ CAR⁺ T cells in 11 patients).
As of February 22, 2025, the median follow-up duration was 53.3 months (range:14.8, 63.5). Thirteen (92.9%) patients experienced cytokine release syndrome all at grade 1 or 2. There were no reports of immune effector cell-associated neurotoxicity syndrome, delayed neurotoxicities or other delayed AEs on the study. Three patients died at month 42.5, 32.6 and 48.5, respectively; none were related to zevor‑cel.
The overall response rate was 100% (95% CI; 76.8, 100.0) with 11 (78.6%) patients achieving complete response (CR) or stringent complete response (sCR), 2 (14.3%) achieving very good partial response and 1 (7.1%) achieving partial response. All patients who achieved CR or better were minimal residual disease (MRD) negative at 10^-5 threshold. One patient remained in sCR at 59.3 months in the study.
The median PFS was 25.8 (95% CI; 14.88, 46.72) months. The PFS rate at 36 and 48 months were 41.7% and 15.6%, respectively. The median duration of response was 24.9 (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. The median overall survival (OS) was not reached. The proportion of patients surviving at 24, 36, 48 and 60 months after infusion were 100%, 92.3%, 84.6% and 76.9%, respectively.

Conclusions: At approximately 5 years of follow-up, zevor-cel demonstrates manageable safety profile while eliciting deep and durable responses in RRMM patients.