Mosunetuzumab, a CD20×CD3 T-cell engaging bispecific antibody, redirects T cells to eliminate malignant B cells. We present updated efficacy and safety data of a pivotal phase 1/2 study after a median follow-up of 37.4 months in 90 patients with relapsed/refractory (R/R) follicular lymphoma (FL) and ≥2 prior lines of therapy treated with fixed-duration mosunetuzumab. Investigator-assessed complete response (CR) rate and objective response rate were 60.0% (95% confidence interval [CI], 49.1-70.2) and 77.8% (95% CI, 67.8-85.9), respectively. Among 70 responders, median duration of response was 35.9 months (95% CI, 20.7 to not estimable [NE]). Among 54 patients who achieved CR, 49 remained in CR at the end of treatment; median duration of CR was not reached (NR; 95% CI, 33.0 to NE); Kaplan-Meier-estimated 30-month remission rate was 72.4% (95% CI, 59.2-85.6). Estimated 36-month overall survival (OS) rate was 82.4% (95% CI, 73.8-91.0); median OS was NR (95% CI, NE to NE). Median progression-free survival was 24.0 months (95% CI, 12.0 to NE). Median time to CD19+ B-cell recovery was 18.4 months (95% CI, 12.8-25.0) after 8 cycles of mosunetuzumab treatment. No new cytokine release syndrome events or fatal, serious, or grade ≥3 adverse events were reported. With extended follow-up, mosunetuzumab demonstrated high response rates, durable remissions, and manageable safety with no long-term concerns. This supports outpatient mosunetuzumab administration as an off-the-shelf, fixed-duration, safe, and effective treatment for patients with R/R FL, including those with high-risk disease. This trial was registered at www.ClinicalTrials.gov as #NCT02500407.

中文翻译：

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mosunetuzumab 在既往 ≥2 次治疗后复发或难治性滤泡性淋巴瘤中的长期 3 年随访


Mosunetuzumab 是一种 CD20×CD3 T 细胞结合双特异性抗体，可重定向 T 细胞以消除恶性 B 细胞。我们展示了一项关键 1/2 期研究的最新疗效和安全性数据，该研究在 90 名复发/难治性 （R/R） 滤泡性淋巴瘤 （FL） 和 ≥2 线既往治疗接受过固定持续时间 mosunetuzumab 治疗的患者中位随访 37.4 个月后。研究者评估的完全缓解 （CR） 率和客观缓解率分别为 60.0% （95% 置信区间 [CI]，49.1-70.2） 和 77.8% （95% CI，67.8-85.9）。在 70 名反应者中，中位反应持续时间为 35.9 个月 （95% CI，20.7 至不可估计 [NE]）。在 54 例达到 CR 的患者中，49 例在治疗结束时仍处于 CR 状态;未达到 CR 的中位持续时间 （NR;95% CI，33.0 至 NE）;Kaplan-Meier 估计的 30 个月缓解率为 72.4% （95% CI，59.2-85.6）。估计 36 个月总生存率 （OS） 为 82.4% （95% CI，73.8-91.0）;中位 OS 为 NR （95% CI，NE 至 NE）。中位无进展生存期为 24.0 个月 （95% CI，12.0 至 NE）。mosunetuzumab 治疗 8 个周期后，CD19+ B 细胞恢复的中位时间为 18.4 个月 （95% CI，12.8-25.0）。未报告新的细胞因子释放综合征事件或致死性、严重或 ≥3 级不良事件。随着随访时间的延长，mosunetuzumab 表现出高反应率、持久缓解和可控的安全性，无需长期担忧。这支持门诊 mosunetuzumab 给药作为 R/R FL 患者（包括高危疾病患者）的现成、固定持续时间、安全和有效的治疗方法。该试验在 www.ClinicalTrials.gov 注册为 #NCT02500407。