The Phase 2 portion of this study evaluated safety and efficacy of polatuzumab vedotin 1.8 mg/kg and venetoclax 800 mg, plus fixed-dose obinutuzumab 1000 mg or rituximab 375 mg/m² in patients with relapsed/refractory (R/R) follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), respectively. Patients with complete response (CR) or partial response (PR)/stable disease (FL) or CR/PR (DLBCL) at end of induction (EOI; six 21-day cycles) received post-induction therapy with venetoclax and obinutuzumab or rituximab, respectively. Primary endpoint was CR rate at EOI. Safety-evaluable populations included 74 patients (FL cohort; median age 64 years; progression of disease within 24 months on first-line treatment, 25.7%; FL International Prognostic Index 3–5, 54.1%; ≥2 previous therapies, 74.3%) and 57 patients (DLBCL cohort; median age 65 years; International Prognostic Index 3–5, 54.4%; ≥2 previous therapies, 77.2%). The most common non-hematologic adverse events (mostly Grades 1–2) in the FL and DLBCL cohorts were diarrhea (55.4% and 47.4%, respectively) and nausea (47.3% and 36.8%); neutropenia was the most common Grades 3–4 toxicity (39.2% and 52.6%). Efficacy-evaluable populations included patients treated at the recommended Phase 2 dose (FL, n = 49; DLBCL, n = 48). CR rates at EOI were 59.2% (FL) and 31.3% (DLBCL); median progression-free survival was 22.8 months (95% confidence interval [CI], 14.5—not evaluable) and 4.6 months (95% CI, 3.6–8.1), respectively. Polatuzumab vedotin plus venetoclax and obinutuzumab/rituximab had acceptable safety in patients with R/R FL or DLBCL, with promising response rates in R/R FL, including high-risk patients.

中文翻译：

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Polatuzumab vedotin、venetoclax 和抗 CD20 单克隆抗体治疗复发/难治性 B 细胞非霍奇金淋巴瘤


本研究的第 2 期部分评估了 polatuzumab vedotin 1.8 mg/kg 和 Venetoclax 800 mg 以及固定剂量 obinutuzumab 1000 mg 或利妥昔单抗 375 mg/m ² 在复发/难治性患者中的安全性和有效性（ R/R) 滤泡性淋巴瘤 (FL) 或弥漫性大 B 细胞淋巴瘤 (DLBCL)。在诱导结束时（EOI；六个 21 天周期）达到完全缓解 (CR) 或部分缓解 (PR)/疾病稳定 (FL) 或 CR/PR (DLBCL) 的患者接受了诱导后维奈托克和 obinutuzumab 或利妥昔单抗治疗， 分别。主要终点是 EOI 时的 CR 率。可安全评估的人群包括 74 名患者（FL 队列；中位年龄 64 岁；一线治疗后 24 个月内疾病进展，25.7%；FL 国际预后指数 3-5，54.1%；≥2 种既往治疗，74.3%） 57 名患者（DLBCL 队列；中位年龄 65 岁；国际预后指数 3-5，54.4%；≥2 种既往治疗，77.2%）。 FL 和 DLBCL 队列中最常见的非血液学不良事件（大多为 1-2 级）是腹泻（分别为 55.4% 和 47.4%）和恶心（47.3% 和 36.8%）；中性粒细胞减少症是最常见的 3-4 级毒性（39.2% 和 52.6%）。可评估疗效的人群包括接受推荐 2 期剂量治疗的患者（FL，n = 49；DLBCL，n = 48）。 EOI 时的 CR 率为 59.2% (FL) 和 31.3% (DLBCL)；中位无进展生存期分别为 22.8 个月（95% 置信区间 [CI]，14.5——不可评估）和 4.6 个月（95% CI，3.6-8.1）。 Polatuzumab vedotin 联合维奈托克和 obinutuzumab/利妥昔单抗在 R/R FL 或 DLBCL 患者中具有可接受的安全性，在 R/R FL（包括高危患者）中具有良好的缓解率。