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The single-arm, phase II LUMMICAR STUDY 1 (NCT03975907) investigated the safety and efficacy of zevorcabtagene autoleucel (zevor-cel), a B-cell maturation antigen (BCMA)-targeting chimeric antigen receptor (CAR) T-cell therapy, in 102 Chinese patients with relapsed/refractory multiple myeloma (RRMM). The primary endpoint was objective response rate (ORR) as per the International Myeloma Working Group (IMWG) 2016 criteria, determined by an independent review committee (IRC). Findings were published by Chen et al. in Experimental Hematology & Oncology.
Key data: The ORR was 92.2%, with 68.6% of patients achieving stringent complete response (sCR), 2.9% achieving complete response (CR), 19.6% achieving very good partial response (VGPR), and 1.0% achieving partial response (PR). The 18-month progression-free survival (PFS) and overall survival (OS) rates were 61.9% and 83.3%, respectively. Cytokine release syndrome (CRS) occurred in 90.2% of patients, with 6.9% experiencing Grade 3–4 CRS. Any-grade immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 2% of patients.1
Key learning: Zevor-cel achieved deep and durable responses with a manageable safety profile in heavily pretreated Chinese patients with RRMM. This represents a significant therapeutic advance for these patients, offering comparable efficacy to international products with a potentially superior safety profile.1 National Medical Products Administration (NMPA) approval for the treatment of adult patients with RRMM who have progressed after ≥3 prior lines of therapy addresses a critical gap in access to novel therapies in China.2
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