Comparison of zuberitamab plus CHOP versus rituximab plus CHOP for the treatment of drug-naïve patients diagnosed with CD20-positive diffuse large B-cell lymphoma: a phase 3 trial

作者：Zhiming Li, Wenqi Jiang, Hui Zhou, Hong Cen, Mingzhi Zhang, Fangfang Lv, Qingyuan Zhang, Xiuhua Sun, Lihong Liu, Yunhong Huang, Haiyan Yang, Sujun Gao, Chuan He, Wei Yang, Wenyu Li, Ding Yu, Yu Yang, Ying Cheng, Zhengzi Qian, Ying Xiang, Qunyi Guo, Bing Xu, Yuqin Song, Liling Zhang, Lie Lin, Jianzhen Shen, Feng Yan, Huilan Liu, Donghua Zhang, Jishi Wang, Min Zhou, Xiongpeng Zhu, Weihua Zhang, Weili Zhao, Ru Feng, Xiaohong Zhang, Jie Jin, Mei-Zuo Zhong, Mei Zhang, Jingbo Wang, Hongmei Jing, Zhao Wang, Hongguo Zhao, Jun Zhu · 发表于：Journal for ImmunoTherapy of Cancer · 年份：2024 · DOI：10.1136/jitc-2024-008895 · 被引用次数：6 · 研究领域：Lymphoma Diagnosis and Treatment、CAR-T cell therapy research、CNS Lymphoma Diagnosis and Treatment

BACKGROUND: In patients with untreated CD20-positive diffuse large B-cell lymphoma (DLBCL), a phase 3 trial was carried out to evaluate the efficacy and safety of zuberitamab plus CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone; Hi-CHOP) versus rituximab plus CHOP (R-CHOP) treatment regimens. METHODS: zuberitamab or rituximab together with conventional CHOP chemotherapy. The objective response rate (ORR) at C6D50 served as the primary endpoint, and a non-inferiority margin of 10% was established. The secondary endpoints included the complete response (CR) rate at C6D50, duration of response (DOR), progression-free survival (PFS) and event-free survival (EFS) judged by blinded-independent review committee (BIRC), overall survival (OS) and safety outcomes. RESULTS: Of the 487 randomized patients, 423 patients including 287 in the Hi-CHOP and 136 in the R-CHOP groups completed the C6D50 assessment. For the full analysis set (FAS) and per-protocol set (PPS), BIRC-assessed ORR at C6D50 for the Hi-CHOP and R-CHOP groups were 83.5% versus 81.4% and 95.3% versus 93.7%, respectively. The non-inferiority was confirmed as the lower limit of the two-sided 95% CI for the intergroup differences of -5.2% and -3.3%; both were >-10% in the FAS and PPS. The BIRC-assessed CR rate of Hi-CHOP was significantly higher in PPS (85.7% vs 77.3%, p=0.038), but comparable in FAS (75.2% vs 67.9%, p=0.092). After a median follow-up of 29.6 months, patients in the Hi-CHOP group had a sligh...