Genentech, Inc., South San Francisco, California, USA.
F. Hoffmann-La Roche Ltd, Basel, Switzerland.
Leuk Lymphoma. 2023 Dec;64(14):2269-2278. doi: 10.1080/10428194.2023.2262066. Epub 2023 Dec 25.
A comparison of clinical outcomes in the third or subsequent line (3 L+) of systemic therapy between a real-world data (RWD) external control cohort and a mosunetuzumab single-arm clinical trial cohort is presented. Data for 3 L + patients with relapsed/refractory follicular lymphoma (FL) were obtained from the mosunetuzumab single-arm trial ( = 90) and a US electronic health records database ( = 158), with patients meeting key eligibility criteria from the trial, balanced on pre-specified prognostic factors. Overall response and complete response rates were 80% and 60% in the mosunetuzumab cohort and 75% and 33% in the RWD cohort, odds ratios of 1.23 (95% CI, 0.52-2.93) and 3.18 (95% CI, 1.41-7.17), respectively. Hazard ratios for progression-free survival and overall survival were 0.82 (95% CI, 0.53-1.27) and 0.43 (95% CI, 0.19-0.94). These findings support a clinically meaningful benefit of mosunetuzumab monotherapy as a chemotherapy-free option for the 3 L + FL population.
本文比较了真实世界数据（RWD）外部对照队列和 mosunetuzumab 单臂临床试验队列中系统治疗三线或后线（3L+）的临床结局。复发/难治性滤泡淋巴瘤（FL）3L+患者的数据来自 mosunetuzumab 单臂试验（n=90）和美国电子健康记录数据库（n=158），患者符合试验的关键入选标准，并根据预先指定的预后因素进行了平衡。mosunetuzumab 队列的总缓解率和完全缓解率分别为 80%和 60%，RWD 队列分别为 75%和 33%，优势比分别为 1.23（95%CI，0.52-2.93）和 3.18（95%CI，1.41-7.17）。无进展生存期和总生存期的风险比分别为 0.82（95%CI，0.53-1.27）和 0.43（95%CI，0.19-0.94）。这些发现支持 mosunetuzumab 单药治疗作为三线及以上 FL 人群的无化疗选择具有临床意义的获益。
