SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has approved a label update for Yescarta® (axicabtagene ciloleucel) to include the overall survival (OS) primary analysis from the landmark Phase 3 ZUMA-7 study showing a statistically significant improvement for Yescarta in OS versus standard of care (SOC) as second-line treatment with curative intent for patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) within 12 months of completion of first-line therapy..

加利福尼亚州圣莫尼卡市——（商业新闻短讯）——吉列德公司Kite（纳斯达克代码：GILD），今天宣布，美国食品和药物管理局（FDA）已批准Yescarta®（axicabtagene ciloleucel）的标签更新，以包括具有里程碑意义的3期ZUMA-7研究的总生存期（OS）初步分析，显示Yescarta在OS方面与标准护理（SOC）相比有统计学意义的改善，作为复发患者具有治愈意图的二线治疗或一线治疗完成后12个月内难治性大B细胞淋巴瘤（R/R LBCL）。。

The label update is based on results from the ZUMA-7 study which demonstrated a 27.4% reduction in the risk of death with Yescarta versus SOC, a relative 38% improvement in OS. With an estimated median follow up of 46.7 months overall, the primary analysis of OS showed a statistically significant improvement in the Yescarta arm compared to the standard therapy arm, despite more than half of patients (57%) in the SOC arm subsequently receiving cell therapy off protocol.

标签更新基于ZUMA-7研究的结果，该研究表明Yescarta与SOC相比死亡风险降低了27.4%，OS相对提高了38%。总体估计中位随访时间为46.7个月，OS的主要分析显示，与标准治疗组相比，Yescarta组有统计学意义上的显着改善，尽管SOC组中超过一半的患者（57%）随后接受了细胞治疗方案。

The estimated 39-month OS rates were 55.9% in the Yescarta arm and 46% in the SOC arm..

Yescarta组估计39个月的OS率为55.9%，SOC组为46%。。

“This U.S. label update for Yescarta is an important step to reinforce healthcare provider confidence to treat eligible patients with Yescarta, immediately following progression or relapse in large B-cell lymphoma,” said Frank Neumann, MD, PhD, Senior Vice President and Global Head of Clinical Development, Kite.

Kite高级副总裁兼全球临床开发负责人Frank Neumann博士说：“Yescarta的美国标签更新是加强医疗保健提供者治疗符合条件的Yescarta患者的信心的重要一步，在大B细胞淋巴瘤进展或复发后立即进行治疗。”。

“Our ZUMA-7 overall survival analysis proves that when given as second-line therapy, Yescarta is even more effective in improving patient survival than standard of care treatment. Coupled with our rapid and reliable manufacturing, it is our hope to provide patients a chance to live longer lives.”.

“我们的ZUMA-7总体生存分析证明，当作为二线治疗时，Yescarta在改善患者生存方面比标准治疗更有效。再加上我们快速可靠的制造，我们希望为患者提供延长寿命的机会。”。

SOC therapy for this patient population has historically been a multi-step process expected to end with stem-cell transplant. The process starts with chemoimmunotherapy, and if a patient responds and can tolerate further treatment, they move on to high-dose chemotherapy (HDT), followed by autologous stem cell transplant (ASCT).

历史上，该患者群体的SOC治疗一直是一个多步骤的过程，预计将以干细胞移植结束。这个过程从化学免疫疗法开始，如果患者有反应并且可以耐受进一步的治疗，他们会继续进行高剂量化疗（HDT），然后进行自体干细胞移植（ASCT）。

Despite this being the prior SOC, less than 40% of patients who started this multi-step process made it through to complete stem cell transplant, compared with 94% of patients randomized to Yescarta in the ZUMA-7 study who received a one-time Yescarta infusion..

尽管这是之前的SOC，但开始这一多步骤过程的患者中只有不到40%成功完成了干细胞移植，而在ZUMA-7研究中随机接受Yescarta的患者中，有94%接受了一次性Yescarta输注。。

Underscoring the Significance for Patients

强调对患者的重要性

As the first and only treatment in nearly 30 years to improve survival for patients with R/R LBCL in this setting, Yescarta can potentially change the standard of care for these patients who previously had limited options for long-term remission.

作为近30年来第一个也是唯一一个在这种情况下提高R/R LBCL患者生存率的治疗方法，Yescarta可能会改变这些患者的护理标准，这些患者以前的长期缓解选择有限。

“Lymphoma Research Foundation has continuously supported efforts for the development of new treatments in large B-cell lymphoma with the shared goal of finding a cure,” said Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation. “We applaud Kite for bringing the oncology community one step closer to eradicating large B-cell lymphoma and offering new hope to patients.”.

淋巴瘤研究基金会（Lymphoma Research Foundation）首席执行官梅根·古铁雷斯（Meghan Gutierrez）表示：“淋巴瘤研究基金会（Lymphoma Research Foundation）一直在支持开发大型B细胞淋巴瘤的新疗法，其共同目标是找到治愈方法。”。“我们赞扬Kite使肿瘤学界更接近根除大B细胞淋巴瘤，并为患者带来新的希望。”。

In November 2023, the European Medicines Agency approved an update to the Summary of Product Characteristics (SmPC) to include the ZUMA-7 overall survival analysis.

2023年11月，欧洲药品管理局（European Medicines Agency）批准了对产品特征总结（SmPC）的更新，以包括ZUMA-7总体生存分析。

*Treatment of curative intent is a line of treatment administered with the goal of achieving a durable complete response/ remission. 2017. NIH National Library of Medicine “Curative, Life-Extending and Palliative Chemotherapy: New Outcomes Need New Names”

*治疗意图的治疗是一种治疗方案，旨在实现持久的完全缓解/缓解。2017年。美国国立卫生研究院国家医学图书馆“治愈性，延长寿命和姑息性化疗：新的结果需要新的名称”

About ZUMA-7 Study

关于ZUMA-7研究

ZUMA-7 is a randomized, open-label, global, multicenter, Phase 3 study evaluating the safety and efficacy of Yescarta versus SOC for initial treatment of adult patients with R/R LBCL within 12 months of first-line therapy. In the study, 359 patients in 77 centers around the world were randomized (1:1) to receive a single infusion of Yescarta or prior SOC second-line treatment.

ZUMA-7是一项随机，开放标签，全球，多中心的3期研究，评估Yescarta与SOC在一线治疗12个月内对成人R/R LBCL患者进行初始治疗的安全性和有效性。在这项研究中，全球77个中心的359名患者被随机（1:1）接受单次输注Yescarta或之前的SOC二线治疗。

The primary endpoint is EFS as determined by blinded central review and defined as the time from randomization to the earliest date of disease progression per Lugano Classification, commencement of new lymphoma therapy, or death from any cause. Key secondary endpoints include objective response rate (ORR) and OS.

主要终点是由盲法中央评估确定的EFS，定义为从随机化到每个卢加诺分类疾病进展的最早日期，开始新的淋巴瘤治疗或任何原因导致的死亡的时间。关键的次要终点包括客观缓解率（ORR）和OS。

Additional secondary endpoints include patient reported outcomes (PROs) and safety. Per hierarchical testing of primary and key secondary endpoints and group sequential testing of OS, an interim analysis of OS occurred at the time of the primary EFS analysis. The prespecified primary OS analysis was to be conducted after 210 deaths or no later than five years after the first patient was randomized..

其他次要终点包括患者报告的结果（PRO）和安全性。根据主要和关键次要终点的分层测试以及操作系统的组顺序测试，在主要EFS分析时发生了操作系统的中期分析。预先指定的主要OS分析将在210例死亡后或不迟于第一名患者随机分组后五年进行。。

Yescarta demonstrated a 2.5-fold increase in patients who were alive at two years and did not experience cancer progression or require the need for additional cancer treatment (40.5% vs. 16.3%) and a four-fold greater median EFS (8.3 mo. vs. 2.0 mo.) compared to SOC (hazard ratio 0.398; 95% CI: 0.308-0.514, P<0.0001).

Yescarta显示，与SOC相比，存活两年且未经历癌症进展或需要额外癌症治疗的患者（40.5%比16.3%）增加了2.5倍，中位EFS（8.3 mo比2.0 mo）增加了四倍（风险比0.398；95%CI:0.308-0.514，P＜0.0001）。

In addition to being the largest and longest study of its kind, ZUMA-7 study participants on the Yescarta arm did not receive additional bridging chemotherapy that could have potentially confounded results..

除了是同类研究中规模最大、时间最长的研究外，Yescarta组的ZUMA-7研究参与者没有接受额外的桥接化疗，这可能会混淆结果。。

Nearly three times as many patients randomized to Yescarta ultimately received the definitive CAR T-cell therapy treatment (94%) versus those randomized to SOC (35%) who received on-protocol HDT+ASCT. More patients responded to Yescarta (ORR: 83% vs. 50%, odds ratio: 5.31 [95% CI: 3.1-8.9; P<0.0001) and achieved a complete response (CR) with Yescarta (CR rate: 65% vs.

随机分配到Yescarta的患者最终接受了明确的CAR T细胞治疗（94%），而随机分配到SOC的患者（35%）接受了HDT+ASCT方案。更多患者对Yescarta有反应（ORR:83%比50%，优势比：5.31[95%CI:3.1-8.9；P＜0.0001]），并对Yescarta达到完全缓解（CR）（CR率：65%比。

32%) than with SOC. At the time of the primary EFS analysis, more than half of patients in the SOC arm subsequently received Yescarta off study..

在主要EFS分析时，SOC组中超过一半的患者随后接受了Yescarta off研究。。

In the study, Yescarta had a safety profile that was consistent with previous studies. Among the 168 Yescarta-treated patients evaluable for safety, Grade ≥3 cytokine release syndrome (CRS) and neurologic events were observed in 7% and 25% of patients, respectively. In the SOC arm, 83% of patients had high grade events, mostly cytopenias (low blood counts)..

在这项研究中，Yescarta的安全性与之前的研究一致。在168名接受Yescarta治疗的可评估安全性的患者中，分别有7%和25%的患者观察到≥3级细胞因子释放综合征（CRS）和神经系统事件。在SOC组中，83%的患者发生高级别事件，主要是血细胞减少（低血细胞计数）。。

The Yescarta U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Yescarta is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

Yescarta美国处方信息对CRS和神经系统毒性的风险提出了盒装警告，并且由于这些风险，Yescarta获得了风险评估和缓解策略（REMS）的批准；有关重要的安全信息，请参见下文。

About Large B-Cell Lymphoma (LBCL)

关于大B细胞淋巴瘤（LBCL）

Globally, LBCL is the most common type of non-Hodgkin lymphoma (NHL). In the United States, more than 18,000 people are diagnosed with LBCL each year. About 30-40% of patients with LBCL will need second-line treatment, as their cancer will either relapse (return) or become refractory (not respond) to initial treatment..

在全球范围内，LBCL是最常见的非霍奇金淋巴瘤（NHL）类型。在美国，每年有18000多人被诊断出患有LBCL。大约30-40%的LBCL患者需要二线治疗，因为他们的癌症会复发（复发）或对初始治疗变得难治（无反应）。。

About Yescarta (Axicabtagene Ciloleucel)

关于叶斯卡塔（Axicabtagene Ciloleucel）

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

请参阅完整的美国处方信息，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定向的基因修饰自体T细胞免疫疗法，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细胞淋巴瘤患者对一线化学免疫治疗无效或在一线化学免疫治疗后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.

经过两种或多种全身治疗后复发或难治性大B细胞淋巴瘤的成年患者，包括未另行说明的弥漫性大B细胞淋巴瘤（DLBCL），原发性纵隔大B细胞淋巴瘤，高度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.

使用局限性：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 the response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial(s)..

两种或多种全身治疗后复发或难治性滤泡性淋巴瘤（FL）的成年患者。该适应症根据响应率在加速批准下获得批准。是否继续批准该适应症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、 美国重要安全信息

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。不要给活动性感染或炎症性疾病患者服用YESCARTA。用托珠单抗或托珠单抗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的患者发生神经系统毒性，包括致命或危及生命的反应，包括与CRS同时或在CRS消退后。用YESCARTA治疗后监测神经系统毒性。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只能通过风险评估和缓解策略（REMS）下的限制性计划获得，称为YESCARTA和TECARTUS REMS计划。

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% (256/276) 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.

发生了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≥3级的患者占9%。93%（256/276）的大B细胞淋巴瘤（LBCL）患者发生CRS，其中≥3级的患者占9%。在接受YESCARTA治疗后死亡的LBCL患者中，有4例在死亡时持续发生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 LBCL患者，CRS发作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中的LBCL患者，CRS发作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 the median duration was 6 days (range: 1-27 days) for patients with iNHL..

ZUMA-5中84%（123/146）的惰性非霍奇金淋巴瘤（iNHL）患者发生CRS，其中≥3级的患者占8%。在接受YESCARTA治疗后死亡的iNHL患者中，有1名患者在死亡时持续发生CRS事件。对于iNHL患者，CRS发作的中位时间为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.

在随后的2组ZUMA-1 LBCL患者中评估了托珠单抗和/或皮质类固醇对CRS发生率和严重程度的影响。在接受托珠单抗和/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）为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的那天开始，对39名患者进行了皮质类固醇预防性治疗3天。39例患者中有31例（79%）发生CRS，并接受托珠单抗和/或治疗剂量的皮质类固醇治疗，无患者发生≥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，但考虑到个体患者预先存在的合并症以及4级风险和长期神经毒性的可能性，预防性皮质类固醇的风险和益处。。

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输注之前有2剂托珠单抗可用。在经过认证的医疗机构至少每天监测患者CRS的体征和症状7天，然后监测4周。如果CRS的体征或症状随时出现，建议患者立即就医。

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

在CRS的第一个症状出现时，按照指示进行支持治疗，托珠单抗或托珠单抗和皮质类固醇治疗。。

NEUROLOGIC TOXICITIES

神经系统毒性

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系统毒性（包括免疫效应细胞相关神经毒性综合征）。接受YESCARTA治疗的所有NHL患者中有78%（330/422）发生神经系统毒性，其中≥3级的患者占25%。ZUMA-1中LBCL患者中有87%（94/108）发生神经系统毒性，其中≥3级患者占31%，ZUMA-7患者中有74%（124/168）发生神经系统毒性，其中≥3级患者占25%。

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 the 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 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 LBCL患者神经系统毒性发作的中位时间为5天（范围：1-133天），中位持续时间为15天。77%（112/146）的iNHL患者发生神经系统毒性，其中21%的患者≥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..

中位发病时间为6天（范围：1-79天），中位持续时间为16天。LBCL患者所有神经系统毒性的98%和iNHL患者所有神经系统毒性的99%发生在YESCARTA输注的前8周内。87%的LBCL患者和74%的iNHL患者在输注后的前7天内发生神经系统毒性。。

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系统毒性（≥10%）包括脑病（50%），头痛（43%），震颤（29%），头晕（21%），失语症（17%），deli妄（15%）和失眠（10%）。注意到持续长达173天的脑病。发生了严重事件，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.

在随后的2组ZUMA-1 LBCL患者中评估了托珠单抗和/或皮质类固醇对神经系统毒性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治疗的患者中，神经系统毒性发生率为78%（32/41），20%（8/41）有3级神经系统毒性；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.

神经系统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的那天开始，对39名患者进行了皮质类固醇预防性治疗3天。在这些患者中，85%（33/39）发生神经系统毒性，8%（3/39）发生3级，5%（2/39）发生4级神经系统毒性。

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 a higher grade of neurologic toxicities or prolongation of neurologic toxicities, delay the onset of and decrease the duration of CRS..

神经系统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和神经系统毒性的预防性皮质类固醇可能导致更高级别的神经系统毒性或神经系统毒性的延长，延迟CRS的发作并缩短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.

在经过认证的医疗机构至少每天7天监测患者的神经系统毒性体征和症状，然后监测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和神经系统毒性的风险，YESCARTA只能通过一项名为YESCARTA和TECARTUS REMS计划的限制性计划获得，该计划要求：分配和管理YESCARTA的医疗机构必须登记并符合REMS要求，并且必须在现场，如果需要治疗CRS，请在YESCARTA输注后2小时内立即为每位患者输注至少2剂托珠单抗。

Certified healthcare facilities must ensure that healthcare providers who prescribe, dispense, or administer YESCARTA 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、分发或管理YESCARTA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

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 infections occurred in 17% of patients, including ≥ Grade 3 infections with an unspecified pathogen in 12%, bacterial infections in 5%, viral infections in 3%, and fungal infections in 1%.

发生严重或危及生命的感染。45%的NHL患者发生感染（所有级别）；≥17%的患者发生3级感染，包括≥3级感染，未指定病原体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不应用于临床上显着的活动性全身感染患者。在输注前后监测患者的感染体征和症状，并进行适当治疗。根据当地指南服用预防性抗菌药物。。

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症，可能与CRS同时发生。在发热性中性粒细胞减少症的情况下，根据医学指示评估感染并使用广谱抗生素，液体和其他支持性护理进行管理。

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，包括那些接受过YESCARTA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（例如念珠菌败血症和曲霉菌感染）和病毒再激活（例如人类疱疹病毒-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..

患有神经系统事件的免疫抑制患者应考虑HHV-6脑炎和PML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, including YESCARTA. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing..

乙型肝炎病毒（HBV）再激活，在某些情况下会导致暴发性肝炎，肝衰竭和死亡，可能发生在使用针对B细胞的药物（包括YESCARTA）治疗的患者中。在收集用于制造的细胞之前，根据临床指南进行HBV，HCV和HIV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..

在淋巴清除化疗和YESCARTA输注后，患者可能会出现血细胞减少症数周。≥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%）。输注后监测血细胞计数。。

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细胞发育不全和低丙种球蛋白血症。据报道，14%的NHL患者出现低丙种球蛋白血症的不良反应。监测治疗后的免疫球蛋白水平，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..

在YESCARTA治疗期间以及治疗后免疫恢复之前，不建议在开始淋巴清除化疗之前至少6周内接种活病毒疫苗。。

SECONDARY MALIGNANCIES

继发性恶性肿瘤

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.

可能会发生继发性恶性肿瘤。终身监测继发性恶性肿瘤。如果发生这种情况，请致电1-844-454-Kite（5483）与Kite联系，以获取有关患者样本收集以进行测试的说明。

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES

对驾驶和使用机器能力的影响

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，患者在输注YESCARTA后8周内有意识或协调能力改变或降低的风险。建议患者在初始阶段不要驾驶和从事危险职业或活动，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 an unspecified pathogen, dizziness, tremor, decreased appetite, edema, hypoxia, abdominal pain, aphasia, constipation, and vomiting..

ZUMA-7 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、寒战、咳嗽、感染不明病原体、头晕、震颤、食欲下降、水肿、缺氧、腹痛、失语、便秘，还有呕吐。。

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 an unspecified, nausea, hypoxia, tremor, cough, vomiting, dizziness, constipation, and cardiac arrhythmias..

ZUMA-1 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，食欲下降，寒战，腹泻，发热性中性粒细胞减少症，感染不明，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 an unspecified, tachycardia, febrile neutropenia, musculoskeletal pain, nausea, tremor, chills, diarrhea, constipation, decreased appetite, cough, vomiting, hypoxia, arrhythmia, and dizziness..

ZUMA-5中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，感染不明，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，食欲下降，咳嗽，呕吐，缺氧，心律失常和头晕。。

About Kite

关于Kite

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 supply and commercial product manufacturing..

基列德公司Kite是一家总部位于加利福尼亚州圣莫尼卡的全球生物制药公司，专注于治疗和潜在治愈癌症的细胞疗法。作为全球细胞疗法的领导者，Kite治疗的CAR T细胞疗法患者比其他任何公司都多。Kite拥有全球最大的内部细胞治疗制造网络，涵盖工艺开发、载体制造、临床试验供应和商业产品制造。。

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 and cancer.

吉利德科学公司（Gilead Sciences，Inc.）是一家生物制药公司，三十多年来一直致力于医学领域的突破，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，以预防和治疗威胁生命的疾病，包括艾滋病毒、病毒性肝炎和癌症。

Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Gilead Sciences acquired Kite in 2017..

吉利德在全球35多个国家开展业务，总部位于加利福尼亚州福斯特城。吉利德科学公司于2017年收购了风筝公司。。

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; the possibility that Gilead and Kite may make a strategic decision to discontinue development of any programs for indications currently under evaluation and, as a result, these programs and/or indications may never be successfully commercialized; the risk that physicians may not see the benefits of prescribing Yescarta; 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案》所指的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德和凯特在目前预期的时间表内或根本没有启动、进展或完成临床试验的能力，以及正在进行的或其他临床研究（包括涉及Yescarta的研究）可能产生不利结果的可能性；Gilead和Kite可能会做出战略决定，停止开发目前正在评估的适应症项目，因此这些项目和/或适应症可能永远不会成功商业化；医生可能看不到开Yescarta的好处的风险；以及基于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 September 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.

这些以及其他风险、不确定性和因素在吉利德提交给美国证券交易委员会的截至2023年9月30日的季度10-Q表季度报告中有详细描述。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及的结果存在重大差异。

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均为可被视为前瞻性陈述的陈述。读者应注意，任何此类前瞻性陈述都不能保证未来的表现，并涉及风险和不确定性，并应注意不要过度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..

所有前瞻性声明均基于Gilead和Kite目前可获得的信息，Gilead和Kite不承担任何义务，也不打算更新任何此类前瞻性声明。。

U.S. Prescribing Information for Yescarta including BOXED WARNING, is available at www.kitepharma.com and www.gilead.com .

U、 有关Yescarta的美国处方信息，包括盒装警告，请访问www.kitepharma.com和www.gilead.com。

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

Kite、Kite徽标、Yescarta和GILEAD是GILEAD Sciences，Inc.或其关联公司的商标。

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Kite的更多信息，请访问公司网站www.kitepharma.com。在社交媒体X（@kitepharma）和LinkedIn上关注Kite。