FOSTER CITY, Calif. & SANTA MONICA, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, will share 29 presentations, including 10 oral presentations, during the 65th American Society of Hematology (ASH) Annual Meeting and Exposition (December 9-12).

加利福尼亚州福斯特城和加利福尼亚州圣莫尼卡-吉利德科学公司（纳斯达克股票代码：吉利德）和吉利德公司凯特将在第65届会议期间分享29次演讲，包括10次口头演讲。美国血液学会（ASH）年会和博览会（12月9日至12日）。

Key presentations for Yescarta (axicabtagene ciloeleucel) in relapsed/refractory (R/R) large B-cell lymphoma (R/R LBCL) across lines of therapy include: three-year results from ZUMA-12 investigating CAR T-cell therapy as part of first-line treatment; ZUMA-7 overall survival sub-group analysis in patients aged 65+; and post-hoc analyses showing the curative intent of Yescarta using six-year follow-up data from ZUMA-1.

Yescarta（axicabtagene ciloeleucel）在复发/难治性（R/R）大B细胞淋巴瘤（R/R LBCL）中跨治疗方案的主要介绍包括：ZUMA-12研究CAR T细胞治疗的三年结果作为一线治疗的一部分；ZUMA-7 65岁以上患者的总生存亚组分析；和事后分析显示Yescarta使用ZUMA-1六年随访数据的治愈意图。

Additional Yescarta research will focus on new four-year follow-up results from ZUMA-5 evaluating Yescarta in R/R indolent non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma..

额外的Yescarta研究将集中于ZUMA-5评估Yescarta治疗R/R惰性非霍奇金淋巴瘤（包括滤泡性淋巴瘤和边缘区淋巴瘤）的新的四年随访结果。。

“We’re pleased to present new data that continue to support the long-term survival and durability of response of our CAR T-cell therapies in blood cancers, across lines of therapy and age groups,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite. “Data from our ZUMA-7 sub-analysis will show that Yescarta can help older adults with relapsed/refractory large B-cell lymphoma live longer, underscoring that age is not a barrier to adult patients being treated with CAR T.”.

Frank Neumann博士说：“我们很高兴提供新的数据，继续支持我们的CAR T细胞疗法在血液癌症，治疗和年龄组中的长期生存和持久性。”Kite全球临床开发总监高级副总裁。“来自ZUMA-7子分析的数据将显示Yescarta可以帮助复发/难治性大B细胞淋巴瘤的老年人活得更长，强调年龄不是CAR T.治疗成年患者的障碍。”。

The largest real-world evidence dataset for Tecartus (brexucabtagene autoleucel) in adult relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and relapsed/refractory mantle cell lymphoma (R/R MCL) will also be presented. Additionally, four-year overall survival data from ZUMA-2 and a ZUMA-18 primary analysis of expanded access in R/R MCL will be highlighted in an oral presentation..

还将介绍成人复发/难治性B细胞急性淋巴细胞白血病（R/R B-ALL）和复发/难治性套细胞淋巴瘤（R/R MCL）中Tecartus（brexucabtagene autoleucel）的最大真实世界证据数据集。此外，ZUMA-2的四年总生存数据和R/R MCL扩大获取的ZUMA-18主要分析将在口头报告中突出显示。。

New data from the Phase 1 study of CART-dd BCMA will be presented from our multiple myeloma partner, Arcellx. CART-ddBCMA is Arcellx’s BCMA-specific CAR-modified T-cell therapy with a novel D-Domain BCMA binder that may improve CAR T-cell binding and killing of multiple myeloma cells.

来自CART-dd-BCMA的1期研究的新数据将来自我们的多发性骨髓瘤合作伙伴Arcellx。CART-ddBCMA是Arcellx的BCMA特异性CAR修饰的T细胞疗法，具有新型D结构域BCMA结合剂，可改善CAR T细胞结合并杀死多发性骨髓瘤细胞。

Dates and times* for accepted abstracts and presentations of note are as follows:

接受摘要和演示文稿的日期和时间*如下：

*Times listed are in PT

*列出的时间在PT

Oral Presentations

口头陈述

Abstract Details

抽象细节

Titles

标题

Large B-cell Lymphoma

大B细胞淋巴瘤

Abstract #103

摘要＃103

Saturday, December 9, 2023

2023年12月9日星期六

9:30 AM

9： 上午30点

Room 6A

6A室

Real-World Evidence in the United States (US) of the Impact of Bridging Therapy Prior to Axicabtagene Ciloleucel (Axi-cel) for the Treatment of Relapsed or Refractory Large B-cell Lymphoma (R/R LBCL)

美国（美国）现实世界的证据表明，在Axicabtagene Ciloleucel（Axi-cel）治疗复发或难治性大B细胞淋巴瘤（R/R LBCL）之前进行桥接治疗的影响

Abstract #223

摘要＃223

Saturday, December 9, 2023

2023年12月9日星期六

2:00 PM

2： 下午00点

Room 6CF

房间6CF

Baseline Immune State and T-cell Clonal Kinetics are Associated with Response to CAR-T Therapy in Large B-cell Lymphoma*

基线免疫状态和T细胞克隆动力学与大B细胞淋巴瘤对CAR-T治疗的反应相关*

*In collaboration with Dana Farber Cancer Institute

*与达纳-法伯癌症研究所合作

Abstract #226

摘要＃226

Saturday, December 9, 2023

2023年12月9日星期六

2:45 PM

2： 下午45点

Room 6CF

房间6CF

Pre- and Post-treatment Immune Contexture Correlates with Long Term Response in Large B-cell Lymphoma Patients Treated with Axicabtagene Ciloleucel (Axi-cel)*

治疗前和治疗后免疫环境与用Axicabtagene Ciloleucel（Axi-cel）治疗的大B细胞淋巴瘤患者的长期反应相关*

*In collaboration with Veracyte

*与Veracyte合作

Abstract #894

摘要＃894

Monday, December 11, 2023

2023年12月11日星期一

4:00 PM

4： 下午00点

Room 6A

6A室

3-Year Analysis of ZUMA-12: A Phase 2 Study of Axicabtagene Ciloleucel (Axi-cel) as First-Line Therapy in Patients with High-Risk Large B-cell Lymphoma (LBCL)

ZUMA-12的3年分析：Axicabtagene Ciloleucel（Axi-cel）作为高危大B细胞淋巴瘤（LBCL）患者一线治疗的2期研究

Abstract #224

摘要＃224

Saturday, December 9, 2023

2023年12月9日星期六

2:15 PM

2： 下午15点

Room 6CF

房间6CF

An Inflammatory Biomarker Signature Reproducibly Predicts CAR T Treatment Failure in Patients with Aggressive Lymphoma Across the ZUMA Trial Cohorts*

炎症生物标志物标签可重复预测ZUMA试验队列中侵袭性淋巴瘤患者的CAR T治疗失败*

*In collaboration with Memorial Sloan Kettering Cancer Center

*与斯隆-凯特琳纪念癌症中心合作

Mantle Cell, Follicular and Other Indolent B-Cell Lymphomas

套细胞，滤泡性和其他惰性B细胞淋巴瘤

Abstract #106

摘要＃106

Saturday, December 9, 2023

2023年12月9日星期六

10:15 AM

10： 上午15点

Room 6A

6A室

Outcomes of Patients with Relapsed/Refractory Mantle Cell Lymphoma (R/R MCL) Treated with Brexucabtagene Autoleucel (Brexu-cel) in ZUMA-2 and ZUMA-18, an Expanded Access Study

ZUMA-2和ZUMA-18中用Brexucabtagene Autoleucel（Brexu-cel）治疗复发/难治性套细胞淋巴瘤（R/R MCL）患者的结果，一项扩展的获取研究

Abstract #107

摘要＃107

Saturday, December 9, 2023

2023年12月9日星期六

10:30 AM

10： 上午30点

Room 6A

6A室

Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL): A CIBMTR Subgroup Analysis of High-Risk Characteristics

Brexucabtagene Autoleucel（Brexu-cel）治疗复发或难治性（R/R）套细胞淋巴瘤（MCL）的实际结果：CIBMTR高危特征亚组分析

Abstract #224

摘要＃224

Saturday, December 9, 2023

2023年12月9日星期六

2:45 PM

2： 下午45点

Room 30

30号房间

Advancing CAR-T Therapy in Acute Lymphoblastic Leukemia: Multi-Omic Analyses of CD19-Directed CAR-T Cells Enabled by an Ex Vivo Co-Culture Platform*

推进CAR-T治疗急性淋巴细胞白血病：通过离体共培养平台实现CD19定向CAR-T细胞的多组学分析*

*In collaboration with Lynx Biosciences, Inc.

*与Lynx Biosciences，Inc.合作。

Abstract #1029

摘要＃1029

Monday, December 11, 2023

2023年12月11日星期一

5:00 PM

5： 下午00点

Room 6CF

房间6CF

Real-world Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Adult B-cell Acute Lymphoblastic Leukemia (B-cell ALL): Evidence from the CIBMTR Registry

Brexucabtagene Autoleucel（Brexu-cel）治疗复发或难治性（R/R）成人B细胞急性淋巴细胞白血病（B细胞ALL）的现实结果：来自CIBMTR登记处的证据

Multiple Myeloma

多发性骨髓瘤

Abstract #1023

摘要＃1023

Monday, December 11, 2023

2023年12月11日星期一

5:00 PM

5： 下午00点

Room 6A

6A室

Phase 1 Study of CART-ddBCMA for the Treatment of Patients with Relapsed and/or Refractory Multiple Myeloma: Results from at Least 1-year Follow-up in All Patients*

CART-ddBCMA治疗复发和/或难治性多发性骨髓瘤患者的1期研究：所有患者至少1年随访的结果*

*Led by Kite partner Arcellx

*由风筝合作伙伴Arcellx领导

Poster Presentations

墙报交流

Large B-cell Lymphoma

大B细胞淋巴瘤

Abstract #1761

摘要＃1761

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:30 PM

5： 下午30-7:30

Halls G-H

G-H大厅

Improved Overall Survival with Axicabtagene Ciloleucel vs. Standard of Care in Second-Line Large B-cell Lymphoma Among the Elderly: A Subgroup Analysis of ZUMA-7

在老年人二线大B细胞淋巴瘤中使用Axicabtagene Ciloleucel与标准治疗相比改善了总体生存率：ZUMA-7的亚组分析

Abstract #1638

摘要＃1638

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:30 PM

5： 下午30-7:30

Halls G-H

G-H大厅

Personal and Shared Tumor-Antigen Prioritization in Diffuse Large B-cell Lymphoma Patients Undergoing CD19 CAR T-cell Treatment*

在接受CD19 CAR T细胞治疗的弥漫性大B细胞淋巴瘤患者中个人和共享的肿瘤抗原优先化*

*In collaboration with Beth Deaconess Israel Medical Center

*与贝斯女执事以色列医疗中心合作

Abstract #2336

摘要＃2336

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:30 PM

5： 下午30-7:30

Halls G-H

G-H大厅

Economic Burden Associated with ASCT in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma: A Nationwide Health Insurance Claims Database Study in Japan During 2012-2022

复发/难治性弥漫大B细胞淋巴瘤患者与ASCT相关的经济负担：2012-2022年日本全国健康保险索赔数据库研究

Abstract #4864

摘要＃4864

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Curative Potential of Axicabtagene Ciloleucel (Axi-cel): An Exploratory Long-Term Survival Assessment in Patients with Refractory Large B-cell Lymphoma from ZUMA-1

Axicabtagene Ciloleucel（Axi-cel）的治疗潜力：ZUMA-1难治性大B细胞淋巴瘤患者的探索性长期生存评估

Mantle Cell, Follicular and Other Indolent B-Cell Lymphomas

套细胞，滤泡性和其他惰性B细胞淋巴瘤

Abstract #2121

摘要＃2121

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:30 PM

5： 下午30-7:30

Halls G-H

G-H大厅

Comparative Effectiveness of Axicabtagene Ciloleucel vs Historical Standard-of-Care in Patients with Relapsed or Refractory Follicular Lymphoma: An Analysis of CIBMTR and SCHOLAR-5 Data

复发或难治性滤泡性淋巴瘤患者Axicabtagene Ciloleucel与历史护理标准的比较效果：CIBMTR和SCHOLAR-5数据分析

Abstract #4868

摘要＃4868

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Axicabtagene Ciloleucel (Axi-cel) in Patients with Relapsed/Refractory (R/R) Indolent Non-Hodgkin Lymphoma (iNHL): 4-Year Follow-up from the Phase 2 ZUMA-5 Trial

复发/难治性（R/R）惰性非霍奇金淋巴瘤（iNHL）患者的Axicabtagene Ciloleucel（Axi-cel）：2期ZUMA-5试验的4年随访

Abstract #4424

摘要＃4424

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Physician Treatment Preferences in Relapsed/Refractory Follicular Lymphoma: A Discrete Choice Experiment

复发/难治性滤泡性淋巴瘤的医师治疗偏好：离散选择实验

Abstract #5082

摘要＃5082

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Cost-effectiveness of Axicabtagene Ciloleucel Versus Mosunetuzumab in Relapsed/Refractory Follicular Lymphoma in the US

Axicabtagene Ciloleucel与Mosunetuzumab在美国复发/难治性滤泡性淋巴瘤中的成本效益

Abstract #4869

摘要＃4869

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

An Updated Comparison of Clinical Outcomes from 4-year Follow-up of ZUMA-5 (Axicabtagene Ciloleucel) and the International SCHOLAR-5 External Control Cohort in Relapsed/Refractory Follicular Lymphoma

ZUMA-5（Axicabtagene Ciloleucel）和国际学者-5外部控制队列对复发/难治性滤泡性淋巴瘤4年随访临床结果的最新比较

Abstract #4865

摘要＃4865

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

A Retrospective Intra-Patient Analysis from ZUMA-5: Axicabtagene Ciloleucel (Axi-cel) Compared with Prior Standard-of-Care (SOC) Therapy in Patients with Relapsed/Refractory Follicular Lymphoma

ZUMA-5:Axicabtagene Ciloleucel（Axi-cel）与先前标准治疗（SOC）治疗复发/难治性滤泡性淋巴瘤患者的回顾性患者内分析

Abstract #5136

摘要＃5136

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Matching-Adjusted Indirect Comparison (MAIC) of Brexucabtagene Autoleucel (Brexu-cel) and Pirtobrutinib in Patients with Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL) Previously Treated with a Covalent Bruton Tyrosine Kinase Inhibitor (cBTKi)

先前用共价布鲁顿酪氨酸激酶抑制剂（cBTKi）治疗的复发/难治性（R/R）套细胞淋巴瘤（MCL）患者的Brexucabtagene Autoleucel（Brexu-cel）和Pirtobrutinib的匹配调整间接比较（MAIC）

Abstract #2120

摘要＃2120

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:00 PM

5： 下午30-7:00

Halls G-H

G-H大厅

Assessment of Early Intervention Strategies for Management of Cytokine Release Syndrome and Neurologic Events after Brexucabtagene Autoleucel (Brexu-cel) Treatment in Patients with Relapsed or Refractory Mantle Cell Lymphoma (R/R MCL) in ZUMA-2

ZUMA-2复发或难治性套细胞淋巴瘤（R/R MCL）患者Brexucabtagene Autoleucel（Brexu-cel）治疗后细胞因子释放综合征和神经系统事件的早期干预策略评估

TBD

TBD

A Propensity Score-Matched Analysis on the Outcomes of Brexucabtagene Autoleucel from ZUMA-2 Study and Allogeneic Stem Cell Transplantation from the EBMT Database in Relapsed and Refractory Post-BTKi Mantle Cell Lymphoma*

ZUMA-2研究中Brexucabtagene-Autoleucel结果的倾向评分匹配分析和EBMT数据库中同种异体干细胞移植治疗复发和难治性BTKi后套细胞淋巴瘤*

*In collaboration with EBMT

*与EBMT合作

Higher-Risk Myelodysplastic Syndromes

高风险骨髓增生异常综合征

Abstract #2434

摘要＃2434

Saturday, December 9, 2023

2023年12月9日星期六

5:30 - 7:30 PM

5： 下午30-7:30

Halls G-H

G-H大厅

Evaluation of Disparities in Higher-Risk Myelodysplastic Syndromes (HR-

评估高危骨髓增生异常综合征（HR）的差异-

MDS) Patient Treatment Patterns in a Large US Health System

MDS）美国大型卫生系统中的患者治疗模式

Abstract #5101

摘要＃5101

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

A Patient-Centered Programmatic Approach for Higher-Risk Myelodysplastic Syndromes

以患者为中心的高风险骨髓增生异常综合征的程序化方法

(HR-MDS) in the US Community Oncology Setting

（HR-MDS）在美国社区肿瘤学环境中

Abstract #5100

摘要＃5100

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Machine Learning Approach to Understand Real-World Treatment in Patients with Higher-Risk Myelodysplastic Syndromes

机器学习方法了解高风险骨髓增生异常综合征患者的实际治疗

Abstract #5178

摘要＃5178

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Patient, Caregiver, and Physician Perspectives on Communication in Diagnosing and

患者，护理人员和医生对诊断和诊断沟通的看法

Treating Higher-Risk Myelodysplastic Syndromes: A Qualitative Study

治疗高危骨髓增生异常综合征的定性研究

Multiple Myeloma

多发性骨髓瘤

Abstract #3383

摘要＃3383

Sunday, December 10, 2023

2023年12月10日星期日

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Safety and Tolerability of Magrolimab Combinations in Patients with Relapsed/Refractory Multiple

Magrolimab联合治疗复发/难治性多发性肿瘤的安全性和耐受性

Myeloma (RRMM): Safety Run-in Results from a Phase 2 Study

骨髓瘤（RRMM）：2期研究的安全性磨合结果

Independently Led and Sponsored**

独立领导和赞助**

Abstract #4884

摘要＃4884

Monday, December 11, 2023

2023年12月11日星期一

6:00 - 8:00 PM

6： 00-8:00 PM

Halls G-H

G-H大厅

Cladribine and Cyclophosphamide Lymphodepletion Prior to Axicabtagene Ciloleucel in Relapsed or Refractory Large B-cell Lymphoma

在复发或难治性大B细胞淋巴瘤中，在Axicabtagene Ciloleucel之前的Cladribine和环磷酰胺淋巴细胞清除

Abstract #6126

摘要＃6126

Radiomic Features Prognosticates Treatment Response in CAR T-cell Therapy

放射学特征预测CAR T细胞治疗中的治疗反应

Real World Data of Axicabtagene Ciloleucel as Second Line Therapy for Patients with Large B-cell Lymphoma: First Results of a LYSA Study from the French DESCAR-T Registry

Axicabtagene Ciloleucel作为大B细胞淋巴瘤患者二线治疗的真实数据：法国DESCAR-T登记处LYSA研究的第一个结果

Efficacy and Tolerance of Brexucabtagene Autoleucel in Adults with Relapsed/Refractory B-cell Precursor Acute Lymphoblastic Leukemia – A GRAALL Study from the DESCAR-T Registry

Brexucabtagene Autoleucel对复发/难治性B细胞前体急性淋巴细胞白血病成人的疗效和耐受性-来自DESCAR-T登记处的GRAALL研究

Publication Only

仅发布

Abstract #6899

摘要＃6899

Statistical Challenges from Trials of Potentially Curative Treatments: Validation of Cure Assumptions When Analyzing ZUMA-7 Follow-up Data of Axi-cel and Standard of Care Therapy

潜在治愈性治疗试验的统计学挑战：分析ZUMA-7腋窝随访数据和标准治疗时治愈假设的验证

For more information, including a complete list of abstract titles at the meeting, please visit: https://ash.confex.com/ash/2023/webprogram/start.html

欲了解更多信息，包括会议上摘要标题的完整列表，请访问：https://ash.confex.com/ash/2023/webprogram/start.html

**Presentations independently led and sponsored feature Kite CAR T-cell therapies, but are not included in Kite accepted abstracts.

**演示独立领导和赞助的特色风筝汽车T细胞疗法，但不包括在风筝接受摘要中。

About Yescarta

关于Yescarta

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

请参阅完整的处方信息，包括盒装警告和药物指南。

YESCARTA is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

YESCARTA是一种CD19指导的转基因自体T细胞免疫疗法，适用于治疗：

Adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy.

成人大B细胞淋巴瘤患者一线化疗免疫治疗无效或一线化疗免疫治疗后12个月内复发。

Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

两种或多种全身治疗后复发或难治性大B细胞淋巴瘤的成人患者，包括未另有说明的弥漫性大B细胞淋巴瘤（DLBCL），原发性纵隔大B细胞淋巴瘤，高级别B细胞淋巴瘤，和滤泡性淋巴瘤引起的DLBCL。

Limitations of Use: YESCARTA is not indicated for the treatment of patients with primary central nervous system lymphoma.

使用限制：YESCARTA不适用于原发性中枢神经系统淋巴瘤患者的治疗。

Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s)..

两次或多次全身治疗后复发或难治性滤泡性淋巴瘤（FL）的成人患者。该指示基于响应率在加速批准下获得批准。对该适应症的持续批准可能取决于验证性试验中临床益处的验证和描述。。

U.S. IMPORTANT SAFETY INFORMATION

U、 S.重要的安全信息

BOXED WARNING: CYTOKINE RELEASE SYNDROME AND NEUROLOGIC TOXICITIES

盒装警告：细胞因子释放综合征和神经毒性

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving YESCARTA. Do not administer YESCARTA to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

接受YESCARTA的患者发生细胞因子释放综合征（CRS），包括致命或危及生命的反应。不要给患有活动性感染或炎症性疾病的患者服用YESCARTA。用tocilizumab或tocilizumab和皮质类固醇治疗严重或危及生命的CRS。

Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving YESCARTA, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with YESCARTA. Provide supportive care and/or corticosteroids as needed.

接受YESCARTA的患者发生神经毒性，包括致命或危及生命的反应，包括与CRS同时或CRS消退后。监测用YESCARTA治疗后的神经毒性。根据需要提供支持性护理和/或皮质类固醇。

YESCARTA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the YESCARTA and TECARTUS REMS Program.

YESCARTA只能通过名为YESCARTA和TECARTUS REMS计划的风险评估和缓解策略（REMS）的限制性计划提供。

CYTOKINE RELEASE SYNDROME (CRS)

细胞因子释放综合征（CRS）

CRS, including fatal or life-threatening reactions, occurred. CRS occurred in 90% (379/422) of patients with non- Hodgkin lymphoma (NHL), including ≥ Grade 3 in 9%. CRS occurred in 93% (56/2) of patients with large B-cell lymphoma (LBCL), including ≥ Grade 3 in 9%. Among patients with LBCL who died after receiving YESCARTA, 4 had ongoing CRS events at the time of death.

发生CRS，包括致命或危及生命的反应。90%（379/422）的非霍奇金淋巴瘤（NHL）患者发生CRS，其中9%发生≥3级。大B细胞淋巴瘤（LBCL）患者中有93%（56/2）发生CR，其中9%发生≥3级。在接受YESCARTA后死亡的LBCL患者中，有4例在死亡时正在进行CRS事件。

For patients with LBCL in ZUMA-1, the median time to onset of CRS was 2 days following infusion (range: 1-12 days) and the median duration was 7 days (range: 2-58 days). For patients with LBCL in ZUMA-7, the median time to onset of CRS was 3 days following infusion (range: 1-10 days) and the median duration was 7 days (range: 2-43 days).

对于ZUMA-1中LBCL患者，CRS发病的中位时间为输注后2天（范围：1-12天），中位持续时间为7天（范围：2-58天）。对于ZUMA-7中LBCL患者，CRS发病的中位时间为输注后3天（范围：1-10天），中位持续时间为7天（范围：2-43天）。

CRS occurred in 84% (123/146) of patients with indolent non-Hodgkin lymphoma (iNHL) in ZUMA- 5, including ≥ Grade 3 in 8%. Among patients with iNHL who died after receiving YESCARTA, 1 patient had an ongoing CRS event at the time of death. The median time to onset of CRS was 4 days (range: 1-20 days) and median duration was 6 days (range: 1-27 days) for patients with iNHL..

ZUMA-5无痛性非霍奇金淋巴瘤（iNHL）患者中有84%（123/146）发生CRS，8%发生≥3级。在接受YESCARTA治疗后死亡的iNHL患者中，1例在死亡时有持续的CRS事件。iNHL患者CRS发病的中位时间为4天（范围：1-20天），中位持续时间为6天（范围：1-27天）。。

Key manifestations of CRS (≥ 10%) in all patients combined included fever (85%), hypotension (40%), tachycardia (32%), chills (22%), hypoxia (20%), headache (15%), and fatigue (12%). Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), renal insufficiency, cardiac failure, respiratory failure, cardiac arrest, capillary leak syndrome, multi-organ failure, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome..

所有患者合并CRS（≥10%）的主要表现包括发热（85%），低血压（40%），心动过速（32%），寒战（22%），缺氧（20%），头痛（15%）和疲劳（12%）。可能与CRS相关的严重事件包括心律失常（包括心房颤动和室性心动过速），肾功能不全，心力衰竭，呼吸衰竭，心脏骤停，毛细血管渗漏综合征，多器官衰竭和噬血细胞性淋巴组织细胞增多症/巨噬细胞活化综合征。。

The impact of tocilizumab and/or corticosteroids on the incidence and severity of CRS was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received tocilizumab and/or corticosteroids for ongoing Grade 1 events, CRS occurred in 93% (38/41), including 2% (1/41) with Grade 3 CRS; no patients experienced a Grade 4 or 5 event.

在ZUMA-1的2个随后的LBCL患者队列中评估了托珠单抗和/或皮质类固醇对CRS发病率和严重程度的影响。在接受tocilizumab和/或皮质类固醇治疗正在进行的1级事件的患者中，CRS发生率为93%（38/41），其中2%（1/41）发生3级CRS；没有患者经历4级或5级事件。

The median time to onset of CRS was 2 days (range: 1-8 days) and the median duration of CRS was 7 days (range: 2-16 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Thirty-one of the 39 patients (79%) developed CRS and were managed with tocilizumab and/or therapeutic doses of corticosteroids with no patients developing ≥ Grade 3 CRS.

CRS发病的中位时间为2天（范围：1-8天），CRS的中位持续时间为7天（范围：2-16天）。从输注YESCARTA当天开始，对39名患者进行了3天的皮质类固醇预防性治疗。39例患者中有31例（79%）发生CRS，并用托珠单抗和/或治疗剂量的皮质类固醇治疗，没有患者发生≥3级CRS。

The median time to onset of CRS was 5 days (range: 1-15 days) and the median duration of CRS was 4 days (range: 1-10 days). Although there is no known mechanistic explanation, consider the risk and benefits of prophylactic corticosteroids in the context of pre-existing comorbidities for the individual patient and the potential for the risk of Grade 4 and prolonged neurologic toxicities..

CRS发病的中位时间为5天（范围：1-15天），CRS的中位持续时间为4天（范围：1-10天）。虽然没有已知的机制解释，但考虑预防性皮质类固醇激素治疗个体患者既往合并症的风险和益处，以及4级风险和长期神经毒性的可能性。。

Ensure that 2 doses of tocilizumab are available prior to YESCARTA infusion. Monitor patients for signs and symptoms of CRS at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

确保在YESCARTA输注前有2剂托珠单抗可用。在认证的医疗机构至少每天监测患者CRS的体征和症状，持续7天，之后持续4周。建议患者在任何时候出现CRS的体征或症状时立即就医。

At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated..

在CRS的第一个迹象时，如所示，用支持治疗，tocilizumab或tocilizumab和皮质类固醇进行治疗。。

NEUROLOGIC TOXICITIES

神经毒性

Neurologic toxicities (including immune effector cell-associated neurotoxicity syndrome) that were fatal or life- threatening occurred. Neurologic toxicities occurred in 78% (330/422) of all patients with NHL receiving YESCARTA, including ≥ Grade 3 in 25%. Neurologic toxicities occurred in 87% (94/108) of patients with LBCL in ZUMA-1, including ≥ Grade 3 in 31% and in 74% (124/168) of patients in ZUMA-7 including ≥ Grade 3 in 25%.

发生致命或危及生命的神经毒性（包括免疫效应细胞相关神经毒性综合征）。所有接受YESCARTA治疗的NHL患者中有78%（330/422）发生神经毒性，其中25%发生≥3级。ZUMA-1中LBCL患者中有87%（94/108）发生神经毒性，其中31%以上≥3级，ZUMA-7患者中74%（124/168）发生神经毒性，25%以上≥3级。

The median time to onset was 4 days (range: 1-43 days) and the median duration was 17 days for patients with LBCL in ZUMA-1. The median time to onset for neurologic toxicity was 5 days (range:1- 133 days) and median duration was 15 days in patients with LBCL in ZUMA-7. Neurologic toxicities occurred in 77% (112/146) of patients with iNHL, including ≥ Grade 3 in 21%.

ZUMA-1中LBCL患者的中位发病时间为4天（范围：1-43天），中位持续时间为17天。ZUMA-7中LBCL患者发生神经毒性的中位时间为5天（范围：1-133天），中位持续时间为15天。iNHL患者中有77%（112/146）发生神经毒性，其中21%发生≥3级。

The median time to onset was 6 days (range: 1-79 days) and the median duration was 16 days. Ninety-eight percent of all neurologic toxicities in patients with LBCL and 99% of all neurologic toxicities in patients with iNHL occurred within the first 8 weeks of YESCARTA infusion. Neurologic toxicities occurred within the first 7 days of infusion for 87% of affected patients with LBCL and 74% of affected patients with iNHL..

发病的中位时间为6天（范围：1-79天），中位持续时间为16天。LBCL患者的所有神经毒性的98%和iNHL患者的所有神经毒性的99%发生在YESCARTA输注的前8周内。87%的LBCL患者和74%的iNHL患者在输注的前7天内发生神经毒性。。

The most common neurologic toxicities (≥ 10%) in all patients combined included encephalopathy (50%), headache (43%), tremor (29%), dizziness (21%), aphasia (17%), delirium (15%), and insomnia (10%). Prolonged encephalopathy lasting up to 173 days was noted. Serious events, including aphasia, leukoencephalopathy, dysarthria, lethargy, and seizures occurred.

所有患者中最常见的神经毒性（≥10%）包括脑病（50%），头痛（43%），震颤（29%），头晕（21%），失语（17%），谵妄（15%）和失眠（10%）。注意到持续长达173天的长期脑病。发生严重事件，包括失语症，白质脑病，构音障碍，嗜睡和癫痫发作。

Fatal and serious cases of cerebral edema and encephalopathy, including late-onset encephalopathy, have occurred..

已经发生了致命和严重的脑水肿和脑病病例，包括迟发性脑病。。

The impact of tocilizumab and/or corticosteroids on the incidence and severity of neurologic toxicities was assessed in 2 subsequent cohorts of LBCL patients in ZUMA-1. Among patients who received corticosteroids at the onset of Grade 1 toxicities, neurologic toxicities occurred in 78% (32/41) and 20% (8/41) had Grade 3 neurologic toxicities; no patients experienced a Grade 4 or 5 event.

在ZUMA-1的2个随后的LBCL患者队列中评估了托珠单抗和/或皮质类固醇对神经毒性的发生率和严重程度的影响。在1级毒性发作时接受皮质类固醇激素治疗的患者中，78%（32/41）发生神经毒性，20%（8/41）发生3级神经毒性；没有患者经历4级或5级事件。

The median time to onset of neurologic toxicities was 6 days (range: 1-93 days) with a median duration of 8 days (range: 1-144 days). Prophylactic treatment with corticosteroids was administered to a cohort of 39 patients for 3 days beginning on the day of infusion of YESCARTA. Of those patients, 85% (33/39) developed neurologic toxicities, 8% (3/39) developed Grade 3, and 5% (2/39) developed Grade 4 neurologic toxicities.

神经毒性发作的中位时间为6天（范围：1-93天），中位持续时间为8天（范围：1-144天）。从输注YESCARTA当天开始，对39名患者进行了3天的皮质类固醇预防性治疗。在这些患者中，85%（33/39）发生神经毒性，8%（3/39）发生3级，5%（2/39）发生4级神经毒性。

The median time to onset of neurologic toxicities was 6 days (range: 1-274 days) with a median duration of 12 days (range: 1-107 days). Prophylactic corticosteroids for management of CRS and neurologic toxicities may result in higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset and decrease the duration of CRS..

神经毒性发作的中位时间为6天（范围：1-274天），中位持续时间为12天（范围：1-107天）。用于治疗CRS和神经毒性的预防性皮质类固醇可能导致更高级别的神经毒性或延长神经毒性，延迟CRS的发作并减少CRS的持续时间。。

Monitor patients for signs and symptoms of neurologic toxicities at least daily for 7 days at the certified healthcare facility, and for 4 weeks thereafter, and treat promptly.

在认证的医疗机构至少每天监测患者的神经毒性体征和症状，持续7天，此后持续4周，并及时治疗。

REMS

REMS

Because of the risk of CRS and neurologic toxicities, YESCARTA is available only through a restricted program called the YESCARTA and TECARTUS REMS Program which requires that: Healthcare facilities that dispense and administer YESCARTA must be enrolled and comply with the REMS requirements and must have on-site, immediate access to a minimum of 2 doses of tocilizumab for each patient for infusion within 2 hours after YESCARTA infusion, if needed for treatment of CRS.

由于存在CRS和神经毒性的风险，YESCARTA只能通过名为YESCARTA和TECARTUS REMS计划的限制性计划获得，该计划要求：分发和管理YESCARTA的医疗机构必须注册并符合REMS要求，并且必须在现场，如果需要治疗CRS，在YESCARTA输注后2小时内立即给予每位患者至少2剂托珠单抗用于输注。

Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA are trained about the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483)..

经认证的医疗机构必须确保开具，分配或管理YESCARTA的医疗保健提供者接受有关CRS和神经毒性管理的培训。更多信息请访问www.YescartaTecartusREMS.com或1-844-454-KITE（5483）。。

HYPERSENSITIVITY REACTIONS

超敏反应

Allergic reactions, including serious hypersensitivity reactions or anaphylaxis, may occur with the infusion of YESCARTA.

输注YESCARTA可能会发生过敏反应，包括严重的超敏反应或过敏反应。

SERIOUS INFECTIONS

严重感染

Severe or life-threatening infections occurred. Infections (all grades) occurred in 45% of patients with NHL. Grade 3 or higher infections occurred in 17% of patients, including ≥ Grade 3 or higher infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%.

发生严重或威胁生命的感染。45%的NHL患者发生感染（所有年级）。17%的患者发生3级或更高的感染，包括≥3级或更高的未指定病原体感染12%，细菌感染5%，病毒感染3%，真菌感染1%。

YESCARTA should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines..

YESCARTA不应用于具有临床显着活动性全身感染的患者。监测患者输注前后感染的体征和症状，并进行适当治疗。根据当地指南管理预防性抗菌药物。。

Febrile neutropenia was observed in 36% of all patients with NHL and may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

在所有NHL患者中有36%观察到发热性中性粒细胞减少，并可能与CRS并发。在发热性中性粒细胞减少症的情况下，评估感染并按照医学指示使用广谱抗生素，液体和其他支持治疗。

In immunosuppressed patients, including those who have received YESCARTA, life-threatening and fatal opportunistic infections including disseminated fungal infections (e.g., candida sepsis and aspergillus infections) and viral reactivation (e.g., human herpes virus-6 [HHV-6] encephalitis and JC virus progressive multifocal leukoencephalopathy [PML]) have been reported.

在免疫抑制患者中，包括那些接受YESCARTA治疗的患者，已经报道了危及生命和致命的机会性感染，包括播散性真菌感染（如念珠菌败血症和曲霉菌感染）和病毒再激活（如人疱疹病毒-6[HHV-6]脑炎和JC病毒进行性多灶性白质脑病[PML]）。

The possibility of HHV-6 encephalitis and PML should be considered in immunosuppressed patients with neurologic events and appropriate diagnostic evaluations should be performed. Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells, including YESCARTA.

在有神经系统事件的免疫抑制患者中应考虑HHV-6脑炎和PML的可能性，并应进行适当的诊断评估。用针对B细胞的药物（包括YESCARTA）治疗的患者可能会发生乙型肝炎病毒（HBV）再激活，在某些情况下会导致暴发性肝炎，肝功能衰竭和死亡。

Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing..

在收集制造细胞之前，根据临床指南对HBV，HCV和HIV进行筛查。。

PROLONGED CYTOPENIAS

长期血细胞减少

Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and YESCARTA infusion. ≥ Grade 3 cytopenias not resolved by Day 30 following YESCARTA infusion occurred in 39% of all patients with NHL and included neutropenia (33%), thrombocytopenia (13%), and anemia (8%). Monitor blood counts after infusion..

淋巴清除化疗和YESCARTA输注后患者可能出现血细胞减少症数周。≥在输注YESCARTA后第30天未解决的3级血细胞减少症发生在所有NHL患者中的39%，包括中性粒细胞减少症（33%），血小板减少症（13%）和贫血（8%）。输液后监测血细胞计数。。

HYPOGAMMAGLOBULINEMIA

低丙种球蛋白血症

B-cell aplasia and hypogammaglobulinemia can occur. Hypogammaglobulinemia was reported as an adverse reaction in 14% of all patients with NHL. Monitor immunoglobulin levels after treatment and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement. The safety of immunization with live viral vaccines during or following YESCARTA treatment has not been studied.

可能发生B细胞发育不全和低球蛋白血症。据报道，低血球蛋白血症是所有NHL患者中14%的不良反应。治疗后监测免疫球蛋白水平，并使用感染预防措施，抗生素预防和免疫球蛋白替代进行管理。尚未研究在YESCARTA治疗期间或之后用活病毒疫苗免疫的安全性。

Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during YESCARTA treatment, and until immune recovery following treatment..

不建议在淋巴清除化疗开始前至少6周，YESCARTA治疗期间以及治疗后免疫恢复之前接种活病毒疫苗。。

SECONDARY MALIGNANCIES

继发性恶性肿瘤

Secondary malignancies may develop. Monitor life-long secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

继发性恶性肿瘤可能发展。监测终身继发性恶性肿瘤。如果发生这种情况，请联系Kite 1-844-454-Kite（5483）获取患者样本的说明以收集进行测试。

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

对驱动和使用机器的能力的影响

Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following YESCARTA infusion. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, during this initial period..

由于可能发生神经系统事件，包括精神状态改变或癫痫发作，患者在YESCARTA输注后8周内有改变或降低意识或协调的风险。建议患者在此初始阶段不要驾驶和从事危险的职业或活动，例如操作重型或潜在危险的机器。。

ADVERSE REACTIONS

不良反应

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-7 included fever, CRS, fatigue, hypotension, encephalopathy, tachycardia, diarrhea, headache, musculoskeletal pain, nausea, febrile neutropenia, chills, cough, infection with unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting..

ZUMA-7中LBCL患者最常见的非实验室不良反应（发生率≥20%）包括发热，CRS，疲劳，低血压，脑病，心动过速，腹泻，头痛，肌肉骨骼疼痛，恶心，发热性中性粒细胞减少，发冷，咳嗽，感染未指明的病原体，头晕，震颤，食欲减退，水肿，缺氧，腹痛，失语，便秘，和呕吐。。

The most common adverse reactions (incidence ≥ 20%) in patients with LBCL in ZUMA-1 included CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, decreased appetite, chills, diarrhea, febrile neutropenia, infections with pathogen unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias..

ZUMA-1中LBCL患者最常见的不良反应（发生率≥20%）包括CRS，发热，低血压，脑病，心动过速，疲劳，头痛，食欲减退，寒战，腹泻，发热性中性粒细胞减少，未指明病原体的感染，恶心，缺氧，震颤，咳嗽，呕吐，头晕，便秘和心律失常。。

The most common non-laboratory adverse reactions (incidence ≥ 20%) in patients with iNHL in ZUMA-5 included fever, CRS, hypotension, encephalopathy, fatigue, headache, infections with pathogen unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness..

ZUMA-5 iNHL患者最常见的非实验室不良反应（发生率≥20%）包括发热，CRS，低血压，脑病，疲劳，头痛，未指明病原体感染，心动过速，发热性中性粒细胞减少，肌肉骨骼疼痛，恶心，震颤，寒战，腹泻，便秘，食欲减退，咳嗽，呕吐，缺氧，心律失常和头晕。。

About Tecartus

关于Tecartus

Please see full FDA Prescribing Information, including BOXED WARNING and Medication Guide.

请参阅完整的FDA处方信息，包括盒装警告和药物指南。

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

Tecartus是一种CD19定向的转基因自体T细胞免疫疗法，适用于治疗：

Adult patients with relapsed or refractory mantle cell lymphoma (MCL). This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial..

成人复发或难治性套细胞淋巴瘤（MCL）患者。该指示基于总体响应率和响应持久性在加速批准下获得批准。对该适应症的持续批准可能取决于验证性试验中的临床益处的验证和描述。。

Adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

成人复发或难治性B细胞前体急性淋巴细胞白血病（ALL）患者。

U.S. IMPORTANT SAFETY INFORMATION

U、 S.重要的安全信息

BOXED WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITIES

盒装警告：细胞因子释放综合征和神经毒性

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred in patients receiving Tecartus. Do not administer Tecartus to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

接受Tecartus的患者发生细胞因子释放综合征（CRS），包括危及生命的反应。不要给患有活动性感染或炎症性疾病的患者服用Tecartus。用tocilizumab或tocilizumab和皮质类固醇治疗严重或危及生命的CRS。

Neurologic toxicities, including life-threatening reactions, occurred in patients receiving Tecartus, including concurrently with CRS or after CRS resolution. Monitor for neurologic toxicities after treatment with Tecartus. Provide supportive care and/or corticosteroids as needed.

在接受Tecartus的患者中发生神经毒性，包括危及生命的反应，包括与CRS同时或在CRS消退后。监测Tecartus治疗后的神经毒性。根据需要提供支持性护理和/或皮质类固醇。

Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program.

Tecartus只能通过名为Yescarta和Tecartus REMS计划的风险评估和缓解策略（REMS）的限制性计划提供。

Cytokine Release Syndrome (CRS), including life-threatening reactions, occurred following treatment with Tecartus. CRS occurred in 92% (72/78) of patients with ALL, including ≥ Grade 3 (Lee grading system) CRS in 26% of patients. Three patients with ALL had ongoing CRS events at the time of death. The median time to onset of CRS was five days (range: 1 to 12 days) and the median duration of CRS was eight days (range: 2 to 63 days) for patients with ALL..

用Tecartus治疗后发生细胞因子释放综合征（CRS），包括危及生命的反应。ALL患者中有92%（72/78）发生CRS，其中26%的患者≥3级（Lee分级系统）CRS。三名ALL患者在死亡时正在进行CRS事件。ALL患者CRS发病的中位时间为5天（范围：1至12天），CRS的中位持续时间为8天（范围：2至63天）。。

Ensure that a minimum of two doses of tocilizumab are available for each patient prior to infusion of Tecartus. Following infusion, monitor patients for signs and symptoms of CRS daily for at least seven days at the certified healthcare facility, and for four weeks thereafter. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

确保在输注Tecartus之前每位患者至少有两剂托珠单抗可用。输注后，在认证的医疗机构每天监测患者CRS的体征和症状至少7天，之后监测4周。建议患者在任何时候出现CRS的体征或症状时立即就医。

At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated..

在CRS的第一个迹象时，如所示，用支持治疗，tocilizumab或tocilizumab和皮质类固醇进行治疗。。

Neurologic Events, including those that were fatal or life-threatening, occurred following treatment with Tecartus. Neurologic events occurred in 87% (68/78) of patients with ALL, including ≥ Grade 3 in 35% of patients. The median time to onset for neurologic events was seven days (range: 1 to 51 days) with a median duration of 15 days (range: 1 to 397 days) in patients with ALL.

用Tecartus治疗后发生神经系统事件，包括致命或威胁生命的事件。ALL患者中有87%（68/78）发生神经系统事件，其中35%的患者≥3级。ALL患者神经系统事件发作的中位时间为7天（范围：1至51天），中位持续时间为15天（范围：1至397天）。

For patients with MCL, 54 (66%) patients experienced CRS before the onset of neurological events. Five (6%) patients did not experience CRS with neurologic events and eight patients (10%) developed neurological events after the resolution of CRS. Neurologic events resolved for 119 out of 134 (89%) patients treated with Tecartus.

对于MCL患者，有54名（66%）患者在神经系统事件发作之前经历了CRS。5例（6%）患者未发生CRS伴神经系统事件，8例（10%）在CRS消退后发生神经系统事件。134例（89%）接受Tecartus治疗的患者中有119例神经系统事件得到解决。

Nine patients (three patients with MCL and six patients with ALL) had ongoing neurologic events at the time of death. For patients with ALL, neurologic events occurred before, during, and after CRS in 4 (5%), 57 (73%), and 8 (10%) of patients; respectively. Three patients (4%) had neurologic events without CRS.

9名患者（3名MCL患者和6名ALL患者）在死亡时有持续的神经系统事件。对于ALL患者，4例（5%），57例（73%）和8例（10%）患者在CRS之前，之中和之后发生神经系统事件；分别。3名患者（4%）有无CRS的神经系统事件。

The onset of neurologic events can be concurrent with CRS, following resolution of CRS or in the absence of CRS..

在CRS消退或CRS不存在后，神经系统事件的发作可与CRS同时发生。。

The most common neurologic events (>10%) were similar in MCL and ALL and included encephalopathy (57%), headache (37%), tremor (34%), confusional state (26%), aphasia (23%), delirium (17%), dizziness (15%), anxiety (14%), and agitation (12%). Serious events including encephalopathy, aphasia, confusional state, and seizures occurred after treatment with Tecartus..

MCL和ALL中最常见的神经系统事件（>10%）相似，包括脑病（57%），头痛（37%），震颤（34%），困惑状态（26%），失语（23%），deli妄（17%），头晕（15%），焦虑（14%）和激动（12%）。用Tecartus治疗后发生严重事件，包括脑病，失语，混乱状态和癫痫发作。。

Monitor patients daily for at least seven days for patients with MCL and at least 14 days for patients with ALL at the certified healthcare facility and for four weeks following infusion for signs and symptoms of neurologic toxicities and treat promptly.

在MCL患者中每天监测患者至少7天，在认证的医疗机构中监测ALL患者至少14天，输注后4周内监测神经毒性的体征和症状，并立即治疗。

REMS Program: Because of the risk of CRS and neurologic toxicities, Tecartus is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Yescarta and Tecartus REMS Program which requires that:

REMS计划：由于存在CRS和神经毒性的风险，Tecartus只能通过名为Yescarta和Tecartus REMS计划的风险评估和缓解策略（REMS）的限制性计划获得，该计划要求：

Healthcare facilities that dispense and administer Tecartus must be enrolled and comply with the REMS requirements. Certified healthcare facilities must have on-site, immediate access to tocilizumab, and ensure that a minimum of two doses of tocilizumab are available for each patient for infusion within two hours after Tecartus infusion, if needed for treatment of CRS..

分发和管理Tecartus的医疗机构必须注册并符合REMS要求。经认证的医疗机构必须现场立即使用tocilizumab，并确保如果需要治疗CRS，每位患者在输注Tecartus后两小时内至少有两剂tocilizumab可用于输注。。

Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer Tecartus are trained in the management of CRS and neurologic toxicities. Further information is available at www.YescartaTecartusREMS.com or 1-844-454-KITE (5483).

经认证的医疗机构必须确保开具，分配或管理Tecartus的医疗保健提供者接受CRS和神经毒性管理方面的培训。更多信息请访问www.YescartaTecartusREMS.com或1-844-454-KITE（5483）。

Hypersensitivity Reactions: Serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide (DMSO) or residual gentamicin in Tecartus.

超敏反应：由于Tecartus中的二甲基亚砜（DMSO）或残留庆大霉素，可能发生严重的超敏反应，包括过敏反应。

Severe Infections: Severe or life-threatening infections occurred in patients after Tecartus infusion. Infections (all grades) occurred in 56% (46/82) of patients with MCL and 44% (34/78) of patients with ALL. Grade 3 or higher infections, including bacterial, viral, and fungal infections, occurred in 30% of patients with ALL and MCL.

严重感染：输注Tecartus后患者出现严重或危及生命的感染。56%（46/82）的MCL患者和44%（34/78）的all患者发生感染（所有等级）。30%的ALL和MCL患者发生3级或更高级别的感染，包括细菌，病毒和真菌感染。

Tecartus should not be administered to patients with clinically significant active systemic infections. Monitor patients for signs and symptoms of infection before and after Tecartus infusion and treat appropriately. Administer prophylactic antimicrobials according to local guidelines..

Tecartus不应用于具有临床显着活动性全身感染的患者。监测患者输注Tecartus前后感染的体征和症状，并进行适当治疗。根据当地指南管理预防性抗菌药物。。

Febrile neutropenia was observed in 6% of patients with MCL and 35% of patients with ALL after Tecartus infusion and may be concurrent with CRS. The febrile neutropenia in 27 (35%) of patients with ALL includes events of “febrile neutropenia” (11 (14%)) plus the concurrent events of “fever” and “neutropenia” (16 (21%)).

输注Tecartus后6%的MCL患者和35%的ALL患者出现发热性中性粒细胞减少症，并可能与CRS并发。ALL患者中有27例（35%）的发热性中性粒细胞减少症包括“发热性中性粒细胞减少症”（11（14%））以及同时发生的“发烧”和“中性粒细胞减少症”（16（21%））。

In the event of febrile neutropenia, evaluate for infection and manage with broad spectrum antibiotics, fluids, and other supportive care as medically indicated..

在发热性中性粒细胞减少症的情况下，评估感染情况并按照医学指示使用广谱抗生素，液体和其他支持治疗。。

In immunosuppressed patients, life-threatening and fatal opportunistic infections have been reported. The possibility of rare infectious etiologies (e.g., fungal and viral infections such as HHV-6 and progressive multifocal leukoencephalopathy) should be considered in patients with neurologic events and appropriate diagnostic evaluations should be performed..

在免疫抑制患者中，已经报道了危及生命和致命的机会性感染。神经系统事件患者应考虑罕见感染病因（如真菌和病毒感染，如HHV-6和进行性多灶性白质脑病）的可能性，并应进行适当的诊断评估。。

Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing..

用针对B细胞的药物治疗的患者可能发生乙型肝炎病毒（HBV）再激活，在某些情况下导致暴发性肝炎，肝功能衰竭和死亡。在收集制造细胞之前，根据临床指南对HBV，HCV和HIV进行筛查。。

Prolonged Cytopenias: Patients may exhibit cytopenias for several weeks following lymphodepleting chemotherapy and Tecartus infusion. In patients with MCL, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 55% (45/82) of patients and included thrombocytopenia (38%), neutropenia (37%), and anemia (17%).

延长的血细胞减少症：在淋巴清除化疗和Tecartus输注后，患者可能会出现数周的血细胞减少症。在MCL患者中，55%（45/82）的患者在输注Tecartus后第30天未解决3级或更高级别的血细胞减少症，包括血小板减少症（38%），中性粒细胞减少症（37%）和贫血（17%）。

In patients with ALL who were responders to Tecartus treatment, Grade 3 or higher cytopenias not resolved by Day 30 following Tecartus infusion occurred in 20% (7/35) of the patients and included neutropenia (12%) and thrombocytopenia (12%); Grade 3 or higher cytopenias not resolved by Day 60 following Tecartus infusion occurred in 11% (4/35) of the patients and included neutropenia (9%) and thrombocytopenia (6%).

在所有对Tecartus治疗有反应的ALL患者中，20%（7/35）的患者在Tecartus输注后第30天未解决3级或更高级别的血细胞减少症，包括中性粒细胞减少症（12%）和血小板减少症（12%）；在Tecartus输注后第60天未解决的3级或更高级别的血细胞减少发生在11%（4/35）的患者中，包括中性粒细胞减少症（9%）和血小板减少症（6%）。

Monitor blood counts after Tecartus infusion..

输注Tecartus后监测血细胞计数。。

Hypogammaglobulinemia: B cell aplasia and hypogammaglobulinemia can occur in patients receiving treatment with Tecartus. Hypogammaglobulinemia was reported in 16% (13/82) of patients with MCL and 9% (7/78) of patients with ALL. Monitor immunoglobulin levels after treatment with Tecartus and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement..

低丙种球蛋白血症：接受Tecartus治疗的患者可发生B细胞发育不全和低丙种球蛋白血症。16%（13/82）的MCL患者和9%（7/78）的ALL患者报告有低球蛋白血症。用Tecartus治疗后监测免疫球蛋白水平，并使用感染预防措施，抗生素预防和免疫球蛋白替代进行管理。。

The safety of immunization with live viral vaccines during or following Tecartus treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least six weeks prior to the start of lymphodepleting chemotherapy, during Tecartus treatment, and until immune recovery following treatment with Tecartus..

尚未研究在Tecartus治疗期间或之后用活病毒疫苗免疫的安全性。不建议在淋巴清除化疗开始前至少6周，Tecartus治疗期间接种活病毒疫苗，直至用Tecartus治疗后免疫恢复。。

Secondary Malignancies may develop. Monitor life-long for secondary malignancies. In the event that one occurs, contact Kite at 1-844-454-KITE (5483) to obtain instructions on patient samples to collect for testing.

继发性恶性肿瘤可能发展。监测继发性恶性肿瘤的终身监测。如果发生这种情况，请联系Kite 1-844-454-Kite（5483）获取患者样本的说明以收集进行测试。

Effects on Ability to Drive and Use Machines: Due to the potential for neurologic events, including altered mental status or seizures, patients are at risk for altered or decreased consciousness or coordination in the 8 weeks following Tecartus infusion. Advise patients to refrain from driving and engaging in hazardous activities, such as operating heavy or potentially dangerous machinery, during this period..

对驾驶和使用机器的能力的影响：由于可能发生神经系统事件，包括精神状态改变或癫痫发作，患者在Tecartus输注后8周内有改变或减少意识或协调的风险。建议患者在此期间不要驾驶和从事危险活动，例如操作重型或潜在危险的机器。。

Adverse Reactions: The most common non-laboratory adverse reactions (≥ 20%) were fever, cytokine release syndrome, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.

不良反应：最常见的非实验室不良反应（≥20%）为发热，细胞因子释放综合征，低血压，脑病，心动过速，恶心，寒战，头痛，疲劳，发热性中性粒细胞减少，腹泻，肌肉骨骼疼痛，缺氧，皮疹，水肿，震颤，未指明病原体的感染，便秘，食欲减退和呕吐。

The most common serious adverse reactions (≥ 2%) were cytokine release syndrome, febrile neutropenia, hypotension, encephalopathy, fever, infection with pathogen unspecified, hypoxia, tachycardia, bacterial infections, respiratory failure, seizure, diarrhea, dyspnea, fungal infections, viral infections, coagulopathy, delirium, fatigue, hemophagocytic lymphohistiocytosis, musculoskeletal pain, edema, and paraparesis..

最常见的严重不良反应（≥2%）是细胞因子释放综合征，发热性中性粒细胞减少症，低血压，脑病，发热，未指明病原体感染，缺氧，心动过速，细菌感染，呼吸衰竭，癫痫发作，腹泻，呼吸困难，真菌感染，病毒感染，凝血功能障碍，deli妄，疲劳，噬血细胞性淋巴组织细胞增多症，肌肉骨骼疼痛，水肿和轻瘫。。

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

请参阅完整的处方信息，包括盒装警告和药物指南。

About Arcellx and Kite Pharma Collaboration

关于Arcellx和Kite Pharma合作

Arcellx and Kite, a Gilead Company, recently formed a global strategic collaboration to co-develop and co-commercialize Arcellx's CART-ddBCMA candidate for the treatment of patients with relapsed or refractory multiple myeloma currently in a pivotal Phase 2 study. Kite and Arcellx will jointly advance and commercialize the CART-ddBCMA asset in the United States, and Kite will commercialize the product outside the U.S..

Gilead公司Arcellx和Kite最近成立了全球战略合作组织，共同开发和共同商业化Arcellx的CART ddBCMA候选药物，用于治疗目前处于关键2期研究中的复发或难治性多发性骨髓瘤患者。Kite和Arcellx将在美国共同推进和商业化CART ddBCMA资产，Kite将在美国境外将产品商业化。。

About Gilead Sciences

关于吉利德科学

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer.

Gilead Sciences，Inc。是一家生物制药公司，已经在医学领域取得了三十多年的突破，目标是为所有人创造一个更健康的世界。该公司致力于推进创新药物，预防和治疗威胁生命的疾病，包括艾滋病毒，病毒性肝炎，新型冠状病毒肺炎和癌症。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California..

吉利德（Gilead）在全球35个以上的国家/地区运营，总部位于加利福尼亚州福斯特城。。

About Kite

关于风筝

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, focused on cell therapy to treat and potentially cure cancer. As the global cell therapy leader, Kite has treated more patients with CAR T-cell therapy than any other company. Kite has the largest in-house cell therapy manufacturing network in the world, spanning process development, vector manufacturing, clinical trial production, and commercial product manufacturing..

吉利德公司Kite是一家总部设在加利福尼亚州圣莫尼卡的全球生物制药公司，专注于细胞疗法治疗和潜在治愈癌症。作为全球细胞治疗领导者，风筝治疗CAR T细胞治疗的患者比其他任何公司都要多。风筝拥有全球最大的内部细胞疗法制造网络，涵盖工艺开发，矢量制造，临床试验生产和商业产品制造。。

Forward-Looking Statements

前瞻性声明

This press release includes forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the ability of Gilead and Kite to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical studies, including those involving Yescarta and Tecartus; the possibility that Gilead and Kite may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年“私人证券诉讼改革法”含义内的前瞻性声明，这些声明受风险，不确定性和其他因素的影响，包括吉利德和风筝在当前范围内启动，进展或完成临床试验的能力预期的时间线或根本，以及正在进行或额外的临床研究（包括涉及Yescarta和Tecartus的研究）可能产生不利结果的可能性；吉利德和凯特可能会做出战略决定，停止开发这些计划，因此，这些计划可能永远无法成功商业化，以适应目前正在评估的适应症；以及上述任何一项的任何假设。

These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

这些和其他风险，不确定性和因素在提交给美国证券交易委员会的2023年6月30日止季度的吉利德季度报告中以表格10-Q详细描述。这些风险，不确定性和其他因素可能导致实际结果与前瞻性声明中提到的结果大不相同。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements.

除历史事实陈述外的所有陈述都是可以视为前瞻性陈述的陈述。读者应警惕，任何此类前瞻性陈述都不能保证未来的业绩，并涉及风险和不确定性，并警告不要过分依赖这些前瞻性陈述。

All forward-looking statements are based on information currently available to Gilead and Kite, and Gilead and Kite assume no obligation and disclaim any intent to update any such forward-looking statements..

所有前瞻性陈述均基于Gilead和Kite目前可获得的信息，Gilead和Kite不承担任何义务，也不否认任何意图更新任何此类前瞻性陈述。。

Tecartus, Yescarta, Gilead, and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

Tecartus，Yescarta，Gilead和Gilead徽标是Gilead Sciences，Inc.或其相关公司的商标。

For more information about Gilead, please visit the company’s website at www.gilead.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

有关Gilead的更多信息，请访问公司网站www.Gilead.com或致电1-800-Gilead-5或1-650-574-3000致电Gilead Public Affairs。

For more information on Kite, please visit the company’s website at www.kitepharma.com. Follow Kite on social media on X (@KitePharma) and LinkedIn.

有关风筝的更多信息，请访问公司的网站www.kitepharma.com.Follow Kite on social media on X（@kitepharma）和LinkedIn。