South San Francisco, CA — May 7th, 2025 —

加利福尼亚州南旧金山 — 2025年5月7日 —

Genentech will participate in the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on May 20, 2025 regarding the supplemental Biologics License Application (sBLA) for Columvi

基因泰克将参与2025年5月20日举行的美国食品药品监督管理局（FDA）肿瘤药物咨询委员会（ODAC）会议，讨论关于Columvi的补充生物制品许可申请（sBLA）。

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®

(glofitamab-gxbm) in combination with gemcitabine and oxaliplatin (GemOx) for the treatment of people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant (ASCT).

(glofitamab-gxbm) 联合吉西他滨和奥沙利铂 (GemOx) 用于治疗复发或难治性 (R/R) 弥漫性大B细胞淋巴瘤 (DLBCL) 且不适合自体干细胞移植 (ASCT) 的患者。

The sBLA is based on data from the Phase III STARGLO study, a multicenter, open label, randomized clinical trial, which showed a 41% reduction in the risk of death (hazard ratio [HR]=0.59, 95% CI: 0.40–0.89, p=0.011) versus MabThera

该sBLA基于III期STARGLO研究的数据，这是一项多中心、开放标签、随机临床试验，数据显示与MabThera相比，死亡风险降低了41%（风险比 [HR]=0.59，95%置信区间: 0.40–0.89，p=0.011）。

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/Rituxan

/Rituxan

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(rituximab) plus GemOx in patients treated with Columvi in combination with GemOx. The Columvi combination also met its key secondary endpoints, with a 63% reduction in risk of disease worsening or death (progression-free survival, PFS) compared to R-GemOx (HR=0.37; 95% CI: 0.25–0.55, p<0.0001). A follow-up analysis conducted after all patients had completed therapy (median follow-up of 20.7 months), showed continued benefit in both primary and secondary endpoints.

在使用 Columvi 联合 GemOx 治疗的患者中，(rituximab) 加上 GemOx。Columvi 组合还达到了其关键的次要终点，与 R-GemOx 相比，疾病恶化或死亡风险（无进展生存期，PFS）降低了 63%（HR=0.37；95% CI：0.25-0.55，p<0.0001）。在所有患者完成治疗后进行的随访分析（中位随访时间为 20.7 个月）显示，主要和次要终点均持续获益。

Median OS for people treated with the Columvi combination was 25.5 months, nearly double what was seen for people treated with R-GemOx at 12.9 months (HR=0.62, 95% CI: 0.43-0.88). Safety of the combination appeared consistent with the known safety profiles of the individual medicines.*.

接受Columvi联合治疗的患者的中位总生存期（OS）为25.5个月，几乎是接受R-GemOx治疗的患者12.9个月的两倍（HR=0.62，95% CI：0.43-0.88）。该组合的安全性与其各药物已知的安全性特征一致。*

We look forward to continued collaboration with the FDA and discussions with the advisory committee to support the application process. The FDA PDUFA date for this application is July 20, 2025.

我们期待与FDA继续合作，并与咨询委员会讨论以支持申请过程。该申请的FDA PDUFA日期为2025年7月20日。

STARGLO is the first randomized Phase III study in patients with transplant-ineligible R/R DLBCL to meet its primary endpoint of improving OS, demonstrating the potential of this Columvi combination to improve survival outcomes in earlier lines of treatment. Based on data from the STARGLO study, regulatory submissions for Columvi plus GemOx for the treatment of patients with R/R DLBCL are ongoing around the world.

STARGLO 是首个在不符合移植条件的 R/R DLBCL 患者中达到其改善总生存期（OS）主要终点的随机 III 期研究，展示了这一 Columvi 联合疗法在更早治疗线中改善生存结果的潜力。基于 STARGLO 研究的数据，Columvi 联合 GemOx 用于治疗 R/R DLBCL 患者的监管提交正在全球范围内进行。

In April 2025, the European Commission approved this Columvi combination for the treatment of adult patients with R/R DLBCL not otherwise specified who are ineligible for ASCT..

2025年4月，欧洲委员会批准了这种Columvi组合用于治疗不符合ASCT条件的成人R/R DLBCL患者。

The need for additional, effective treatment options has been acknowledged by the National Comprehensive Cancer Network

国家综合癌症网络承认需要更多、更有效的治疗选择。

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(NCCN

（NCCN

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®

), which has recently added glofitamab-gxbm (Columvi) in combination with GemOx to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines

），该指南最近将 glofitamab-gxbm（Columvi）与 GemOx 联合方案添加到了 NCCN 肿瘤学临床实践指南（NCCN 指南）中。

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) as an NCCN category 1 preferred recommendation for the treatment of people with second-line DLBCL who have relapsed late (>12 months) and are not intended to proceed to transplant, and a category 2A preferred recommendation for those who have relapsed early (<12 months) or have primary refractory disease and are not candidates for CAR T..

) 作为NCCN一类首选推荐，用于治疗复发较晚（>12个月）且无意进行移植的二线DLBCL患者，以及对于复发较早（<12个月）或患有原发难治性疾病且不符合CAR T条件的患者，则为2A类首选推荐。

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*Adverse event (AE) rates were higher with the Columvi combination versus R-GemOx, noting higher median number of cycles received with Columvi combination (11 versus 4). One of the most common AEs was cytokine release syndrome, which was generally low grade (Any Grade: 44.2%, Grade 1: 31.4%, Grade 2: 10.5%, Grade 3: 2.3%) and occurred primarily in Cycle 1. .

与R-GemOx相比，Columvi联合疗法的不良事件（AE）发生率较高，但需注意，接受Columvi联合疗法的中位治疗周期数更多（11个周期对比4个周期）。其中最常见的不良事件之一是细胞因子释放综合征，通常为低级别（任何级别：44.2%，1级：31.4%，2级：10.5%，3级：2.3%），且主要发生在第1周期。

†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，并对它们的应用或使用不承担任何责任。

Columvi, an off-the-shelf, fixed-duration bispecific antibody, received accelerated approval by the U.S. Food and Drug Administration on June 15, 2023 as a monotherapy to treat people with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy based on the pivotal Phase I/II NP30179 study.

2023年6月15日，Columvi作为一种现成的、固定疗程的双特异性抗体，基于关键的I/II期NP30179研究，获得美国食品药品监督管理局加速批准，作为单药治疗经过两线或多线系统治疗后复发或难治性弥漫性大B细胞淋巴瘤患者。

Columvi is currently approved for the third-line indication in over 60 countries and around 6,000 patients, including nearly 2,000 in the U.S., have been treated globally to date..

目前，Columvi已在超过60个国家获批用于三线治疗适应症，全球范围内已有约6000名患者接受治疗，其中包括美国的近2000名患者。

Diffuse large B-cell lymphoma (DLBCL) is an aggressive disease and is the most common form of non-Hodgkin lymphoma in the U.S. Approximately four out of ten patients will relapse after first-line treatment and the majority of patients who require subsequent lines of therapy have poor outcomes. While second-line treatment advances have been made, challenges with the accessibility of existing medicines and the aggressive nature of DLBCL underscores the urgent need for immediately available treatment options that may be able to control the disease and improve survival..

弥漫性大B细胞淋巴瘤（DLBCL）是一种侵袭性疾病，是美国最常见的非霍奇金淋巴瘤类型。大约十分之四的患者在一线治疗后会复发，而需要后续治疗的大多数患者预后较差。尽管二线治疗有所进展，但现有药物的可及性问题以及DLBCL的侵袭性特点凸显了对能够控制疾病并改善生存率的即时可用治疗方案的迫切需求。

Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer..

Columvi（glofitamab-gxbm）是一种处方药，用于治疗患有某些类型弥漫性大B细胞淋巴瘤（DLBCL）或大B细胞淋巴瘤（LBCL）的成人患者，这些患者的疾病已经复发或对先前的治疗无反应（难治性），并且已经接受过两种或更多种前期癌症治疗。

It is not known if Columvi is safe and effective in children.

目前尚不清楚Columvi在儿童中是否安全有效。

The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.

Columvi 的有条件批准是基于反应率和反应的持久性。目前正在进行的研究旨在评估该药物的效果如何。

What is the most important information I should know about Columvi?

我应该知道的关于Columvi的最重要的信息是什么？

Columvi can cause Cytokine Release Syndrome (CRS)

Columvi 可能导致细胞因子释放综合征 (CRS)。

, a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.

，这是在使用Columvi治疗期间常见的严重副作用，也可能非常严重并导致死亡。

Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:

如果出现CRS的任何体征或症状，请立即联系您的医疗保健提供者或寻求紧急医疗帮助，包括：

Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”.

由于CRS的风险，您将按照“逐步加量计划”接受Columvi。

Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.

您的医疗保健提供者在您使用Columvi治疗期间会监测您是否出现CRS，如果您出现CRS的体征和症状，可能会在医院对您进行治疗。如果您有严重的副作用，您的医疗保健提供者可能会暂时停止或完全停止您使用Columvi的治疗。

Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers.

随时携带Columvi患者钱包卡，并向所有医疗服务提供者出示。

The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.

Columvi患者钱包卡列出了您应该立即获得紧急医疗帮助的CRS的体征和症状。

What are the possible side effects of Columvi?

科鲁米可能有哪些副作用？

Columvi may cause serious side effects, including:

科伦威可能会导致严重的副作用，包括：

The most common side effects of Columvi include:

Columvi最常见的副作用包括：

CRS, muscle and bone pain, rash, and tiredness.

CRS、肌肉和骨骼疼痛、皮疹和疲倦。

The most common severe abnormal lab test results with Columvi include

Columvi最常见的严重异常实验室检测结果包括

:

：

decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).

白细胞减少、磷酸盐（一种电解质）减少、尿酸水平升高和纤维蛋白原（一种有助于凝血的蛋白质）减少。

Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.

如果出现某些副作用，您的医疗保健提供者可能会暂时停止或完全停止使用Columvi进行治疗。

Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:

在使用Columvi之前，请告知您的医疗保健提供者您的所有健康状况，包括如果您：

Females who are able to become pregnant:

能够怀孕的女性：

Tell your healthcare provider about all the medicines you take,

告诉您的医疗保健提供者您所服用的所有药物，

including prescription and over-the-counter medicines, vitamins, and herbal supplements.

包括处方药和非处方药、维生素以及草本补充剂。

What should I avoid while receiving Columvi?

我在接受Columvi治疗时应该避免什么？

Do not

不要

drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

如果出现头晕、意识模糊、颤抖（震颤）、嗜睡或任何其他影响意识的症状，请勿驾驶、操作重型机械或进行其他危险活动，直到您的症状消失。这些可能是神经系统问题的征兆和症状。

These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.

这些并非 Columvi 的全部可能副作用。如需了解更多关于 Columvi 的益处和风险的信息，请咨询您的医疗保健提供者。

You may report side effects to the FDA at (800) FDA-1088 or

您可以向 FDA 报告副作用，电话号码是 (800) FDA-1088 或者

http://www.fda.gov/medwatch

http://www.fda.gov/medwatch

. You may also report side effects to Genentech at (888) 835-2555.

您也可以通过电话（888）835-2555向基因泰克报告副作用。

Please see Important Safety Information, including

请参阅重要的安全信息，包括

Serious Side Effects

严重副作用

, as well as the Columvi full

，以及完整的哥伦维

Prescribing Information

处方信息

and

和

Medication Guide

药品指南

or visit

或访问

https://www.Columvi.com

https://www.Columvi.com

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California.

成立于40多年前的基因泰克是一家领先的生物技术公司，致力于发现、开发、生产和销售用于治疗患有严重和危及生命疾病的药物。该公司隶属于罗氏集团，总部位于加利福尼亚州南旧金山。

For additional information about the company, please visit .

有关公司的更多信息，请访问 。

http://www.gene.com

http://www.gene.com

.

。