Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), presented today results from the Phase III SUNMO [

基因泰克（Genentech），罗氏集团（SIX：RO，ROG；OTCQX：RHHBY）的成员，今天公布了III期SUNMO试验的结果 [

NCT05171647

NCT05171647

] study showing Lunsumio

] 研究显示 Lunsumio

(mosunetuzumab-axgb) administered subcutaneously in combination with Polivy

皮下注射（mosunetuzumab-axgb）联合Polivy

(polatuzumab vedotin-piiq) demonstrated a clinically meaningful and statistically significant improvement in its primary endpoints of progression-free survival (PFS) and objective response rate (ORR) compared to Rituxan

（波拉图珠单抗 vedotin-piiq）在无进展生存期（PFS）和客观缓解率（ORR）的主要终点上，与利妥昔单抗相比，显示出具有临床意义且统计学显著的改善。

(rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. Primary analysis data were featured at the 18

（利妥昔单抗）、吉西他滨和奥沙利铂（R-GemOx），用于治疗复发或难治性（R/R）大B细胞淋巴瘤（LBCL）且不符合移植条件的患者。主要分析数据在第18届会议上展示。

International Conference on Malignant Lymphoma as a late-breaking oral presentation.

在国际恶性淋巴瘤会议上作为最新口头报告发表。

Results from the SUNMO study will be submitted to global health authorities, including the U.S. Food and Drug Administration (FDA). The National Comprehensive Cancer Network

SUNMO研究的结果将提交给全球卫生当局，包括美国食品药品监督管理局（FDA）。国家综合癌症网络

) has recently added Lunsumio and Polivy to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines

）最近将Lunsumio和Polivy添加到了NCCN肿瘤学临床实践指南（NCCN指南）中。

) as a category 2A recommendation for the treatment of people with second-line (2L) diffuse large B-cell lymphoma (DLBCL) who are not intended to proceed to transplant.

) 作为不打算进行移植的二线（2L）弥漫性大B细胞淋巴瘤（DLBCL）患者的治疗选择，列为2A类推荐。

“Lunsumio and Polivy represent the first combination of a bispecific antibody and antibody-drug conjugate, which could avoid chemotherapy and potentially provide an alternative option for some patients with relapsed or refractory LBCL,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development.

“Lunsumio和Polivy代表了双特异性抗体和抗体药物偶联物的首个组合，这可以避免化疗，并可能为一些复发或难治性LBCL患者提供替代选择，”首席医学官兼全球产品开发主管Levi Garraway博士表示。

“We are also encouraged by the favorable safety profile and potential for outpatient use of this regimen, which may suit diverse patient and healthcare system needs.”.

“我们还受到该方案良好的安全性以及门诊使用潜力的鼓舞，这可能满足多样化的患者和医疗系统需求。”

At a median follow-up of 23.2 months, the Lunsumio and Polivy combination demonstrated a 59% reduction in risk of disease progression or death compared to R-GemOx (hazard ratio [HR] 0.41, 95% confidence interval [CI]: 0.28–0.61; p<0.0001).

在中位随访23.2个月时，Lunsumio和Polivy联合疗法显示出比R-GemOx降低59%的疾病进展或死亡风险（风险比[HR] 0.41，95%置信区间[CI]：0.28–0.61；p<0.0001）。

Median PFS was three times longer with Lunsumio and Polivy at 11.5 months (95% CI: 5.6-17.6), compared to 3.8 months for R-GemOx (95% CI: 2.9-4.1) and 12-month PFS was more than doubled at 48.5% (95% CI: 39.6-57.4) vs.17.8% (95% CI: 5.4-30.3), respectively. This PFS benefit was consistent across subgroups, including in high-risk patients with primary refractory disease (HR 0.46, 95% CI: 0.29–0.72)..

Lunsumio 和 Polivy 的中位无进展生存期 (PFS) 长达 11.5 个月（95% CI：5.6-17.6），是 R-GemOx（3.8 个月，95% CI：2.9-4.1）的三倍；12 个月 PFS 率更是翻倍，达到 48.5%（95% CI：39.6-57.4），而 R-GemOx 为 17.8%（95% CI：5.4-30.3）。这一 PFS 获益在各亚组中均保持一致，包括高危的原发难治性患者（HR 0.46，95% CI：0.29–0.72）。

At the interim analysis, overall survival (OS) data were not yet mature. OS numerically favored the Lunsumio and Polivy combination with a median of 18.7 months (95% CI: 14.1–not evaluable [NE]) compared to 13.6 months for R-GemOx (95% CI: 9.9–NE; HR 0.80; 95% CI: 0.54 - 1.20).

在中期分析时，总生存期（OS）数据尚未成熟。Lunsumio和Polivy联合治疗组的OS数值上占优，中位数为18.7个月（95%置信区间：14.1–不可评估 [NE]），而R-GemOx组为13.6个月（95%置信区间：9.9–NE；风险比 0.80；95%置信区间：0.54 - 1.20）。

“There remains a clear need for effective and well-tolerated treatments for people with this difficult-to-treat disease,” said Jason Westin, professor of lymphoma and director of lymphoma clinical research, The University of Texas, MD Anderson Cancer Center. “If approved, this off-the-shelf treatment combination of mosunetuzumab-axgb and polatuzumab vedotin-piiq could be administered over a fixed period of time, without mandatory hospitalization or traditional chemotherapy, which could provide a meaningful option for patients with relapsed or refractory LBCL.”.

“对于这种难以治疗的疾病，患者仍然迫切需要有效且耐受性良好的治疗方法，”德克萨斯大学MD安德森癌症中心淋巴瘤教授兼淋巴瘤临床研究主任贾森·韦斯廷表示。“如果获得批准，这种由mosunetuzumab-axgb和polatuzumab vedotin-piiq组成的现成治疗组合可以在固定的时间内进行治疗，无需强制住院或传统化疗，这可能为复发或难治性LBCL患者提供一种有意义的选择。”

In the Lunsumio and Polivy arm, 30% more patients achieved an objective response (70.3%, 95% CI: 61.9-77.8) compared to R-GemOx (40.0%; 95% CI: 28.5-52.4), and the complete response rate was doubled at 51.4% (95% CI: 42.8-60.0) versus 24.3% (95% CI: 14.8-36.0).

在 Lunsumio 和 Polivy 组中，达到客观缓解的患者比例（70.3%，95% CI：61.9-77.8）比 R-GemOx 组（40.0%；95% CI：28.5-52.4）高出 30%，且完全缓解率提高了一倍，分别为 51.4%（95% CI：42.8-60.0）和 24.3%（95% CI：14.8-36.0）。

Nearly 75% of patients with a complete response were still in remission after one year (72.6%; 95% CI: 61.4-83.8) compared to 44.1% for R-GemOx (95% CI: 13.2-74.9).

近75%的完全缓解患者在一年后仍然处于缓解状态（72.6%；95%置信区间：61.4-83.8），而R-GemOx组为44.1%（95%置信区间：13.2-74.9）。

The safety profile of the Lunsumio and Polivy combination was consistent with the known profiles of the individual study medicines, potentially allowing use across outpatient and community settings. The incidence of cytokine release syndrome (CRS) events in the Lunsumio plus Polivy arm was low, occurring in one in four patients, with less than 5% of patients experiencing Grade 2 or 3 CRS events.

Lunsumio 和 Polivy 联合使用的安全性与各研究药物的已知安全性一致，这可能允许在门诊和社区环境中使用。在 Lunsumio 加 Polivy 组中，细胞因子释放综合征 (CRS) 事件的发生率较低，在四分之一的患者中发生，不到 5% 的患者经历了 2 级或 3 级 CRS 事件。

No immune effector cell-associated neurotoxicity syndrome events were reported. Rates of Grade 3–4 (58.5% vs. 57.8%) and Grade 5 (5.2% vs. 6.3%) adverse events (AEs) were similar between the combination and R-GemOx, with fewer AEs leading to treatment discontinuation in the Lunsumio and Polivy arm (2.2% vs.

未报告免疫效应细胞相关神经毒性综合征事件。3-4级（58.5% vs. 57.8%）和5级（5.2% vs. 6.3%）不良事件（AEs）的发生率在联合治疗组和R-GemOx组之间相似，而在Lunsumio和Polivy组中因不良事件导致治疗终止的比例较低（2.2% vs.

4.7%)..

4.7%)..

High-dose chemotherapy followed by stem-cell transplant has traditionally been the standard 2L treatment for people with R/R LBCL. While 2L therapies have advanced, DLBCL can progress rapidly and many people are not candidates for, cannot tolerate, or do not have access to latest therapies. There is an urgent need for treatments that are rapidly available upon a diagnosis of relapse, that can manage the disease and improve long-term outcomes..

高剂量化疗后进行干细胞移植一直是R/R LBCL患者的标准化二线治疗。尽管二线疗法有所进展，但DLBCL可能迅速恶化，许多人不适合、无法耐受或无法获得最新的治疗方法。因此迫切需要在复发诊断后能够快速获得的治疗方案，以控制疾病并改善长期预后。

Genentech’s lymphoma portfolio is one of the broadest in the industry, providing a unique and much-needed opportunity to combine regimens with different and complementary mechanisms of action. We are exploring our CD20xCD3 bispecifics, Lunsumio and Columvi

基因泰克的淋巴瘤产品组合是业内最广泛的之一，这为结合具有不同且互补作用机制的治疗方案提供了独特且亟需的机会。我们正在探索我们的CD20xCD3双特异性抗体，Lunsumio和Columvi。

(glofitamab-gxbm), alongside Polivy to move one step closer towards our goal of improving the lives of as many patients with lymphomas as possible. This includes the Phase III STARGLO study [

（格洛菲塔单抗-gxbm），与Polivy一起，朝着我们改善尽可能多的淋巴瘤患者生活的目标又迈进了一步。这包括III期STARGLO研究 [

NCT04408638

NCT04408638

] evaluating the efficacy and safety of Columvi

] 评估Columvi的有效性和安全性

in combination with GemOx versus R-GemOx alone in patients with R/R DLBCL who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy.

与单独使用R-GemOx相比，联合GemOx用于治疗接受过至少一种先前治疗且不符合自体干细胞移植条件或接受过两种或更多先前治疗的复发/难治性弥漫性大B细胞淋巴瘤（R/R DLBCL）患者。

Lunsumio is already approved for people with R/R follicular lymphoma after two or more lines of therapy in more than 60 countries worldwide. Polivy in combination with R-CHP is approved for people with previously untreated diffuse large B-cell lymphoma (DLBCL) in more than 100 countries worldwide and in combination with bendamustine and Rituxan for R/R DLBCL in more than 90 countries worldwide..

Lunsumio 已在 60 多个国家获批用于接受过两种或以上治疗方案的复发/难治性（R/R）滤泡性淋巴瘤患者。Polivy 联合 R-CHP 方案已在 100 多个国家获批用于初治弥漫性大 B 细胞淋巴瘤（DLBCL）患者，并且与苯达莫司汀和利妥昔单抗联合用于 R/R DLBCL 患者已在 90 多个国家获得批准。

†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way

†NCCN对其内容、使用或应用不作任何形式的保证，并且对于其应用或使用不承担任何责任。

About the SUNMO study

关于SUNMO研究

The SUNMO [

太阳监测天文台 [

NCT05171647

NCT05171647

] study is an international, multi-center, randomized Phase III trial evaluating the efficacy and safety of subcutaneously administered Lunsmio

该研究是一项国际、多中心、随机的 III 期试验，评估皮下注射 Lunsmio 的有效性和安全性。

(mosunetuzumab-axgb) in combination with intravenous Polivy

(mosunetuzumab-axgb) 联合静脉注射 Polivy

(polatuzumab vedotin-piiq) compared to Rituxan

（波拉图珠单抗 vedotin-piiq）与利妥昔单抗相比

(rituximab), gemcitabine and oxaliplatin (R-GemOx), in people with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for autologous stem cell transplant. Outcome measures include progression-free survival and objective response rate (dual primary endpoints), overall survival, duration of objective response, complete response rate, duration of complete response, safety and tolerability, and patient-reported outcomes. .

（利妥昔单抗）、吉西他滨和奥沙利铂（R-GemOx），用于治疗复发或难治性（R/R）大B细胞淋巴瘤（LBCL）且不符合自体干细胞移植条件的患者。结果指标包括无进展生存期和客观缓解率（双重主要终点）、总生存期、客观缓解持续时间、完全缓解率、完全缓解持续时间、安全性和耐受性，以及患者报告的结果。

About Lunsumio

关于 Lunsumio

Lunsumio is a first-in-class CD20xCD3 T-cell-engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual-targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells.

Lunsumio 是一种首创的 CD20xCD3 T 细胞结合双特异性抗体，旨在靶向 B 细胞表面的 CD20 和 T 细胞表面的 CD3。这种双重靶向激活并重新定向患者现有的 T 细胞，通过向 B 细胞释放细胞毒性蛋白来攻击和消除目标 B 细胞。

A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma, diffuse large B-cell lymphoma, and other indications..

Lunsumio 的一项强大的临床开发计划正在进行中，研究该分子作为单一疗法以及与其它药物联合使用，用于治疗患有 B 细胞非霍奇金淋巴瘤（包括滤泡性淋巴瘤、弥漫性大 B 细胞淋巴瘤和其他适应症）的患者。