SANTA MONICA, Calif.--(BUSINESS WIRE)--Kite, a Gilead Company (Nasdaq: GILD), today announced the results of four new analyses supporting the use of Tecartus® (brexucabtagene autoleucel) in relapsed/refractory mantle cell lymphoma (R/R MCL) and relapsed/refractory adult B-cell precursor acute lymphoblastic leukemia (R/R B-ALL).

加利福尼亚州圣莫尼卡（商业新闻短讯）--吉列德公司（Nasdaq:GILD）Kite今天宣布了四项新分析的结果，这些分析支持使用Tecartus®（brexucabtagene autoleucel）治疗复发/难治性套细胞淋巴瘤（R/R MCL）和复发/难治性成人B细胞前体急性淋巴细胞白血病（R/R B-ALL）。

These results include four-year overall survival (OS) data from the pivotal ZUMA-2 study and primary results from ZUMA-18, an expanded access study, evaluating the CAR T-cell therapy Tecartus in patients with R/R MCL that were presented orally (Abstract #106) at the 2023 American Society of Hematology (ASH) Annual Meeting & Exposition..

这些结果包括关键的ZUMA-2研究的四年总生存期（OS）数据和ZUMA-18的主要结果，ZUMA-18是一项扩展的access研究，评估了R/R MCL患者的CAR T细胞治疗Tecartus，这些患者在2023年美国血液学会（ASH）年会和博览会上口头介绍（摘要#106）。。

An analysis from ZUMA-2 showing that patients who received early versus late intervention for management of cytokine release syndrome (CRS) and neurological events experienced improved safety outcomes was also presented in a poster session (Abstract #2120).

ZUMA-2的一项分析显示，接受早期和晚期干预治疗细胞因子释放综合征（CRS）和神经系统事件的患者的安全性结果也有所改善（摘要#2120）。

In addition, real-world findings on effectiveness and safety outcomes from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database of U.S. patients who received Tecartus for R/R MCL (Abstract #107) were highlighted in an oral session; CIBMTR data from adult patients with R/R B-ALL (Abstract #1029) were also presented orally today..

此外，国际血液和骨髓移植研究中心（CIBMTR）观察数据库对接受Tecartus治疗R/R MCL（摘要#107）的美国患者的有效性和安全性结果的真实发现在口头会议上得到了强调；今天还口头介绍了来自成年R/R B-ALL患者的CIBMTR数据（摘要#1029）。。

“The clinical results and real-world evidence presented at ASH clearly support the potential for long-term response and safety of Tecartus in aggressive blood cancers for which patients have limited treatment options,” said Frank Neumann, MD, PhD, Senior Vice President, Global Head of Clinical Development, Kite.

Kite临床开发全球负责人高级副总裁Frank Neumann医学博士说：“在ASH上提供的临床结果和现实证据清楚地支持了Tecartus在侵袭性血癌中长期反应和安全性的潜力，因为患者的治疗选择有限。”。

“We are particularly encouraged that the real-world evidence demonstrates consistent outcomes for Tecartus among a broader range of patients.”.

“我们特别感到鼓舞的是，现实世界的证据表明，Tecartus在更广泛的患者中取得了一致的结果。”。

Detailed Information on Tecartus Abstracts:

关于Tecartus摘要的详细信息：

(Abstract #106)

（摘要#106）

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

在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）患者的结局，一项扩展访问研究

At a median follow-up of 47.5 months in all 68 patients with R/R MCL who had previously received anthracycline or bendamustine-containing chemotherapy; an anti CD20 antibody; and a Bruton’s tyrosine kinase inhibitor (BTKi; ibrutinib or acalabrutinib); and were treated with Tecartus in the pivotal ZUMA-2 study, median OS was 46.4 months with 30 patients (44%) still alive at data cutoff.

所有68例先前接受过蒽环类或含苯达莫司汀化疗的R/R MCL患者的中位随访时间为47.5个月；抗CD20抗体；和布鲁顿酪氨酸激酶抑制剂（BTKi；依鲁替尼或阿卡鲁替尼）；在关键的ZUMA-2研究中，接受了Tecartus治疗，中位OS为46.4个月，数据截止时仍有30名患者（44%）存活。

The median OS for patients with complete response (CR) (n=46) was 58.7 months..

完全缓解（CR）（n=46）患者的中位OS为58.7个月。。

Efficacy and safety outcomes for 23 patients with R/R MCL enrolled in ZUMA-18, a multicenter, open-label, expanded-access study of Tecartus, were also presented. With a median follow-up of 33.5 months, the investigator-assessed objective response rate (ORR) was 87% (95% Confidence Interval [CI], 66.4-97.2); 57% had a CR (95% CI, 34.5-76.8), 30% had a partial response (95% CI, 13.2-52.9), and 9% had progressive disease (95% CI, 1.1-28.0) as their best response to Tecartus.

还介绍了参加ZUMA-18的23例R/R MCL患者的疗效和安全性结果，ZUMA-18是Tecartus的一项多中心，开放标签，扩展访问研究。中位随访时间为33.5个月，研究者评估的客观缓解率（ORR）为87%（95%置信区间[CI]，66.4-97.2）；57%有CR（95%CI，34.5-76.8），30%有部分缓解（95%CI，13.2-52.9），9%有进展性疾病（95%CI，1.1-28.0）是他们对Tecartus的最佳反应。

The median OS was not reached (95% CI, 10.4-not estimable) at data cutoff with a 58% OS rate at 24 months..

数据截止时未达到中位OS（95%CI，10.4-不可估计），24个月时OS率为58%。。

At data cutoff, 61% of patients were still alive. All 23 patients who received Tecartus in ZUMA-18 experienced at least one Grade ≥3 adverse event (AE); Grade ≥3 CRS and neurological events occurred in one patient (4%) and eight patients (35%), respectively. Five Grade 5 AEs occurred, one that was deemed related to Tecartus therapy (multiple organ dysfunction syndrome on Day 20) and four that were deemed unrelated to Tecartus therapy (sepsis [2, Days 123 and 219], aspiration [1, on Day 49], and encephalopathy [1, on Day 68])..

在数据截止时，61%的患者仍然活着。在ZUMA-18接受Tecartus治疗的所有23例患者均经历了至少一次≥3级不良事件（AE）；一名患者（4%）和八名患者（35%）分别发生≥3级CRS和神经系统事件。发生了五次5级AE，其中一次被认为与Tecartus治疗有关（第20天为多器官功能障碍综合征），另外四次被认为与Tecartus治疗无关（败血症[2，第123和219天]，误吸[1，第49天]和脑病[1，第68天]）。。

“Consistent with ZUMA-2 findings, which showed a median overall survival of 46.4 months in patients with a complete response, brexu-cel demonstrated a high level of efficacy in relapsed/refractory mantle cell lymphoma patients in the ZUMA-18 expanded-access study, with less serious cytokine release syndrome,” said Andre Goy, MD, ZUMA-2 investigator and Lymphoma Division Chief, John Theurer Cancer Center, Hackensack University Medical Center.

“与ZUMA-2研究结果一致，ZUMA-2研究者兼淋巴瘤科科长Andre Goy医学博士表示，与ZUMA-2研究结果一致，ZUMA-2研究结果显示完全缓解患者的中位总生存期为46.4个月，brexu-cel在ZUMA-18扩展接入研究中对复发/难治性套细胞淋巴瘤患者表现出高水平的疗效，细胞因子释放综合征较轻。”，哈肯萨克大学医学中心约翰·泰勒癌症中心。

“Together, the results of these two studies provide strong support for the continued use of brexu-cel in the relapsed/refractory mantle cell lymphoma setting.”.

“总之，这两项研究的结果为在复发/难治性套细胞淋巴瘤环境中继续使用brexu-cel提供了强有力的支持。”。

(Abstract #107)

（摘要#107）

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）的现实结果：CIBMTR高危特征亚组分析

Patients with R/R MCL and TP53 mutation/deletion or high Ki-67 proliferation index (PI) have historically had limited treatment options with dismal outcomes. In a previously presented three-year follow-up of ZUMA-2, outcomes were comparable across various high-risk subgroups, including in patients with TP53 mutation or Ki-67 PI ≥ 30% or ≥ 50%..

具有R/R MCL和TP53突变/缺失或高Ki-67增殖指数（PI）的患者历史上的治疗选择有限，结果不佳。在之前提出的ZUMA-2三年随访中，各种高危亚组的结果具有可比性，包括TP53突变或Ki-67 PI≥30%或≥50%的患者。。

An analysis of a CIBMTR observational database of R/R MCL patients receiving Tecartus from 84 U.S. centers was presented. With a median follow-up of 12.2 months, CR rates were high among these challenging-to-treat sub-populations:

介绍了对来自84个美国中心接受Tecartus治疗的R/R MCL患者的CIBMTR观察数据库的分析。中位随访时间为12.2个月，在这些具有挑战性的治疗亚人群中，CR率很高：

For patients with deletion of TP53/17p (n=44), CR was 84% compared to 81% in those without (n=183)

对于TP53/17p缺失的患者（n=44），CR为84%，而无TP53/17p缺失的患者为81%（n=183）

For patients with Ki-67 PI ≥ 50% (n=146), CR was 83% vs 84% in those with Ki-67 PI < 50% (n=111).

Ki-67 PI≥50%（n=146）的患者，CR为83%，Ki-67 PI＜50%（n=111）的患者为84%。

Safety endpoints were largely consistent among all subgroups. Prolonged neutropenia and thrombocytopenia occurred more frequently in patients with vs without deletion of TP53/17p (25% vs 13% and 28% vs 16%, respectively). Grade ≥ 3 CRS occurred more frequently in ZUMA-2-ineligible vs eligible patients (13% vs 7%).

所有亚组的安全终点基本一致。在没有删除TP53/17p的vs患者中，中性粒细胞减少症和血小板减少症的发生频率更高（分别为25%比13%和28%比16%）。ZUMA-2不合格与符合条件的患者发生≥3级CRS的频率更高（13%比7%）。

After multivariable adjustment, all effectiveness and most safety outcomes were consistent regardless of deletion of TP53/17p and Ki-67 >+50%..

经过多变量调整后，无论删除TP53/17p和Ki-67>+50%，所有有效性和大多数安全性结果都是一致的。。

“These real-world findings suggest that outcomes of brexu-cel treatment, including a high complete response rate, are largely consistent, regardless of ZUMA-2 eligibility or the high-risk feature subgroups analyzed. Although patients without deletion of TP53/17p appeared to have longer overall survival than patients with, the data further demonstrate the safety and durability of response of brexu-cel for patients with relapsed/refractory mantle cell lymphoma, who typically face poor prognoses and have limited treatment options,” said Swetha Kambhampati, MD, lead investigator, City of Hope assistant professor, Division of Lymphoma, Department of Hematology & Hematopoietic Cell Transplantation..

“这些现实世界的发现表明，无论ZUMA-2资格或分析的高风险特征亚组如何，brexu-cel治疗的结果（包括高完全缓解率）在很大程度上是一致的。尽管未删除TP53/17p的患者似乎比患有bre的患者总生存期更长，但数据进一步证明了bre反应的安全性和持久性xu cel治疗复发/难治性套细胞淋巴瘤患者，这些患者通常预后不佳，治疗选择有限，”Swetha Kambhampati医学博士，希望之城首席研究员，血液学和造血细胞移植系淋巴瘤科助理教授说道。。

(Abstract #1029)

（摘要#1029）

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

This real-world evidence study of Tecartus in adult patients with B-ALL examined a CIBMTR registry database of 150 patients across 67 centers in the United States.

这项针对成年B-ALL患者的Tecartus的真实证据研究检查了美国67个中心150名患者的CIBMTR登记数据库。

The assessment found the overall complete remission or complete remission with incomplete hematological recovery (CR/CRi) rate by Day 100 post-infusion was 76%, and 70% were still in remission at 6 months post-initial response (95% CI: 55-80). For those who were not in response prior to lymphodepletion (LD), 63% of these patients converted to a CR/CRi post-infusion..

评估发现，输注后第100天的总体完全缓解或完全缓解伴不完全血液学恢复（CR/CRi）率为76%，初始缓解后6个月仍有70%缓解（95%CI:55-80）。对于那些在淋巴清除（LD）之前没有反应的患者，这些患者中有63%在输注后转换为CR/CRi。。

The OS rate at six months was 78% (95% CI: 69-84); primary causes of death were primary disease (n=13/32, 41%) and infection (n=7/32, 22%). About one-third (31%) of responders received a subsequent allogeneic stem cell transplant (allo SCT). High response rates were observed in all patients regardless of age, prior exposure to blinatumomab, prior allo SCT, or the presence of extramedullary disease prior to LD.

6个月时的OS率为78%（95%CI:69-84）；死亡的主要原因是原发性疾病（n=13/32，41%）和感染（n=7/32，22%）。大约三分之一（31%）的应答者接受了随后的同种异体干细胞移植（allo-SCT）。无论年龄，既往接触blinatumomab，既往allo-SCT或LD前是否存在髓外疾病，所有患者均观察到高反应率。

Grade ≥3 CRS and immune effector cell-associated neurotoxicity syndrome (ICANS, ASTCT consensus) occurred in 9% and 24% of patients, respectively. Treatment for CRS and/or ICANS consisted mainly of tocilizumab (67%) and corticosteroids (51%). Most of these AEs were resolved within three weeks of infusion (CRS, 94%; ICANS, 80%).

9%和24%的患者分别发生≥3级CRS和免疫效应细胞相关神经毒性综合征（ICANS，ASTCT共识）。CRS和/或ICAN的治疗主要由托珠单抗（67%）和皮质类固醇（51%）组成。大多数这些AE在输注后三周内得到解决（CRS，94%；ICAN，80%）。

Prolonged cytopenia and neutropenia 30 days post-infusion were experienced by 42% and 33% of patients, respectively..

输注后30天，分别有42%和33%的患者出现长期血细胞减少和中性粒细胞减少。。

“It is encouraging to see that the efficacy and safety outcomes of the largest real-world evidence study of brexu-cel in B-ALL are consistent with the results of the ZUMA-3 study, with high response rates in a broad, actual patient population,” said Evandro Bezerra, MD, lead investigator, hematology specialist, Ohio State University Comprehensive Cancer Center.

俄亥俄州立大学综合癌症中心血液学专家首席研究员、医学博士Evandro Bezerra说：“令人鼓舞的是，brexu-cel在B-ALL中进行的最大规模的真实证据研究的疗效和安全性结果与ZUMA-3研究的结果一致，在广泛的实际患者人群中有很高的反应率。”。

“These findings further build our confidence in the role of brexu-cel in treating adult patients with B-ALL, including those living with high-risk comorbidities and other factors that make treatment particularly challenging.”.

“这些发现进一步建立了我们对brexu cel在治疗成人B-ALL患者中的作用的信心，包括那些患有高风险合并症和其他因素的患者，这些因素使治疗特别具有挑战性。”。

About ZUMA-2

关于ZUMA-2

ZUMA-2 is a single-arm, international multicenter (US and Europe), open-label Phase 2 study involving 74 enrolled/leukapheresed adult patients (≥18 years old) with MCL whose disease is refractory to or has relapsed following up to five prior lines of therapy, including anthracycline or bendamustine-containing chemotherapy, anti-CD20 monoclonal antibody therapy and the BTK inhibitors ibrutinib or acalabrutinib.

ZUMA-2是一项单臂，国际多中心（美国和欧洲）的开放标签2期研究，涉及74名登记/白细胞分离的成年MCL患者（≥18岁），其疾病对先前的五种治疗方案（包括蒽环类或含苯达莫司汀的化疗）难治或复发，抗CD20单克隆抗体疗法和BTK抑制剂依鲁替尼或阿卡拉鲁替尼。

The objectives of the study are to evaluate the efficacy and safety after a single infusion of KTE-X19 in this patient population. The primary endpoint for the study is objective response rate and is defined as the combined rate of complete responses and partial responses as assessed by an Independent Radiology Review Committee.

该研究的目的是评估在该患者群体中单次输注KTE-X19后的疗效和安全性。该研究的主要终点是客观缓解率，定义为独立放射学审查委员会评估的完全缓解率和部分缓解率的总和。

Secondary endpoints include duration of response, best objective response, progression-free survival, OS, incidence of AEs, incidence of anti-CD19 CAR antibodies, levels of anti-CD19 CAR T cells in blood, levels of cytokines in serum, and changes over time in the EQ-5D scale score and visual analogue scale score.

次要终点包括反应持续时间，最佳客观反应，无进展生存期，OS，AE发生率，抗CD19 CAR抗体发生率，血液中抗CD19 CAR T细胞水平，血清细胞因子水平以及EQ-5D量表评分和视觉模拟量表评分随时间的变化。

The study is ongoing..

这项研究正在进行中。。

About ZUMA-18

关于ZUMA-18

The U.S. expanded-access ZUMA-18 trial consists of two cohorts of 27 patients per total. The primary objectives were to provide access to Tecartus for patients with R/R MCL until it was commercially available (Cohort 1) and patients with R/R MCL whose manufactured product did not meet commercial release specifications (Cohort 2).

美国扩展访问ZUMA-18试验由两组共27名患者组成。主要目标是为R/R MCL患者提供使用Tecartus的机会，直到其可商购（队列1）和R/R MCL患者的产品不符合商业释放规格（队列2）。

In Cohort 1, adults (≥18 years) with R/R MCL with ≥1 prior regimen underwent leukapheresis and conditioning chemotherapy followed by a single infusion of Tecartus at a target dose of 2×106 cells/kg (or fixed dose of 2x108 anti-CD19 CAR T cells for patients who are ≥100 kg). In Cohort 2, patients received Cohort 1 treatment without leukapheresis (initial leukapheresis product used).

在队列1中，具有≥1个先前方案的R/R MCL的成人（≥18岁）接受白细胞分离和预处理化疗，然后以2×106个细胞/kg的目标剂量单次输注Tecartus（或对于≥100 kg的患者，固定剂量为2x108个抗CD19 CAR T细胞）。在队列2中，患者接受队列1治疗而不进行白细胞分离术（使用初始白细胞分离产品）。

Key endpoints were safety, ORR, and OS..

关键终点是安全性、ORR和OS。。

About Mantle Cell Lymphoma

关于套细胞淋巴瘤

MCL is a rare form of non-Hodgkin lymphoma (NHL) that arises from cells originating in the “mantle zone” of the lymph node and predominantly affects men over the age of 60. Approximately 33,000 people worldwide are diagnosed with MCL each year. MCL is highly aggressive following relapse, with many patients’ disease progressing following therapy..

MCL是一种罕见的非霍奇金淋巴瘤（NHL），起源于淋巴结“套区”的细胞，主要影响60岁以上的男性。全世界每年约有33000人被诊断出患有MCL。MCL复发后具有高度侵袭性，许多患者的疾病在治疗后进展。。

About Acute Lymphoblastic Leukemia

关于急性淋巴细胞白血病

ALL is an aggressive and rare type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs, and is very challenging to treat. In adults, B-ALL is the most common form, accounting for 75% of cases. Survival rates in adults with R/R B-ALL are poor, with a median OS of less than eight months..

ALL是一种侵袭性和罕见的血癌，也可能涉及淋巴结，脾脏，肝脏，中枢神经系统和其他器官，治疗起来非常具有挑战性。在成年人中，B-ALL是最常见的形式，占病例的75%。患有R/R B-ALL的成年人的生存率很低，中位OS不到八个月。。

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定向的基因修饰自体T细胞免疫疗法，用于治疗：

Adult patients with relapsed or refractory mantle cell lymphoma (MCL).

成人复发或难治性套细胞淋巴瘤（MCL）患者。

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.

根据总体响应率和响应的持久性，该指示在加速批准下获得批准。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。

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

复发或难治性B细胞前体急性淋巴细胞白血病（ALL）的成年患者。

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 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。不要给活动性感染或炎症性疾病患者服用Tecartus。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 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.

接受Tecartus治疗的患者发生神经系统毒性，包括危及生命的反应，包括与CRS同时或在CRS消退后。用Tecartus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。

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), 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。92%（72/78）的ALL患者发生CRS，其中26%的患者发生≥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发作的中位时间为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.

在输注Tecartus之前，确保每位患者至少有两剂托珠单抗可用。输注后，每天在经过认证的医疗机构监测患者CRS的体征和症状至少七天，然后监测四周。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 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，包括致命或危及生命的事件。87%（68/78）的ALL患者发生神经系统事件，其中35%的患者≥3级。ALL患者神经系统事件的中位发病时间为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，54名（66%）患者在神经系统事件发生之前经历了CRS。5名（6%）患者未发生神经系统事件的CRS，8名患者（10%）在CRS消退后发生神经系统事件。在接受Tecartus治疗的134名患者中，有119名（89%）的神经系统事件得到了解决。

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）在死亡时仍有神经系统事件。对于ALL患者，4例（5%），57例（73%）和8例（10%）患者在CRS之前，期间和之后发生神经系统事件；分别。三名患者（4%）患有无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消退后或在没有CRS的情况下，神经系统事件的发作可能与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%），失语症（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.

MCL患者每天至少监测7天，ALL患者每天至少监测14天，输注后四周监测神经系统毒性的体征和症状，并及时治疗。

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CRS和神经系统毒性的风险，Tecartus只能通过风险评估和缓解策略（REMS）下的受限计划获得，称为Yescarta和Tecartus REMS计划，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..

分配和管理Tecartus的医疗机构必须注册并符合REMS要求。如果需要治疗CRS，经认证的医疗机构必须立即在现场使用托珠单抗，并确保每位患者在Tecartus输注后两小时内至少有两剂托珠单抗可用于输注。。

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处方、配药或管理Tecartus的医疗保健提供者接受CRS和神经毒性管理方面的培训。有关更多信息，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：由于二甲基亚砜（DMSO）或Tecartus中残留的庆大霉素，可能会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：Tecartus输注后患者发生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（所有级别）。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不应用于临床上显着的活动性全身感染患者。在Tecartus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 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%)).

Tecartus输注后，6%的MCL患者和35%的ALL患者出现发热性中性粒细胞减少症，可能与CRS同时发生。ALL患者中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例（14%））加上“发热”和“中性粒细胞减少症”的并发事件（16例（21%）。

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

如果出现发热性中性粒细胞减少症，评估感染情况，并按照医学指示使用广谱抗生素、液体和其他支持性护理进行管理。。

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（例如真菌和病毒感染，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，肝衰竭和死亡。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: 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%).

长期血细胞减少症：在淋巴消耗化疗和Tecartus输注后，患者可能会出现血细胞减少症数周。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%).

在对Tecartus治疗有反应的ALL患者中，20%（7/35）的患者在输注Tecartus后第30天未解决3级或更高的血细胞减少症，包括中性粒细胞减少症（12%）和血小板减少症（12%）；Tecartus输注后第60天未解决的3级或更高级别血细胞减少症发生在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..

Tecartus输注后监测血细胞计数。。

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治疗的患者可能发生B细胞发育不全和低丙种球蛋白血症。据报道，16%（13/82）的MCL患者和9%（7/78）的ALL患者出现低丙种球蛋白血症。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。在开始淋巴清除化疗之前，在Tecartus治疗期间以及在用Tecartus治疗后免疫恢复之前，不建议至少六周内接种活病毒疫苗。。

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: 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，患者在输注Tecartus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%）是发热，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症，腹泻，肌肉骨骼疼痛，缺氧，皮疹，水肿，震颤，病原体感染，便秘，食欲下降和呕吐。

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，未指明病原体的感染，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，凝血病，deli妄，疲劳，噬血细胞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 CIBMTR

空关于CIBMTR

The Center for International Blood and Marrow Transplant Research is a nonprofit research collaboration between the NMDP/Be The Match, in Minneapolis, and the Medical College of Wisconsin, in Milwaukee. CIBMTR collaborates with the global scientific community to increase survival and enrich quality of life for patients.

国际血液和骨髓移植研究中心是位于明尼阿波利斯的NMDP/Be The Match与位于密尔沃基的威斯康星州医学院之间的非营利研究合作。CIBMTR与全球科学界合作，提高患者的生存率和生活质量。

CIBMTR facilitates critical observational and interventional research through scientific and statistical expertise, a large network of centers, and a unique database of long-term clinical data for more than 635,000 people who have received hematopoietic cell transplantation and other cellular therapies.

CIBMTR通过科学和统计专业知识、大型中心网络以及635000多名接受过造血细胞移植和其他细胞疗法的人的长期临床数据的独特数据库，促进了关键的观察性和介入性研究。

Learn more at cibmtr.org..

更多信息请访问cibmtr.org。。

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..

吉利德在全球35多个国家运营，总部位于加利福尼亚州福斯特城。。

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 Tecartus; the possibility that Gilead and Kite may make a strategic decision to discontinue development of programs for indications currently under evaluation and, as a result, such indications may never be successfully commercialized; the risk that physicians may not see the benefits of prescribing Tecartus; 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，以及正在进行或其他临床研究（包括涉及Tecartus的临床研究）可能产生不利结果的可能性；Gilead和Kite可能会做出战略决定，停止目前正在评估的适应症项目的开发，因此，这些适应症可能永远不会成功商业化；医生可能看不到处方Tecartus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 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。。

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

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

For more information about Kite, please visit the company’s website at www.kitepharma.com or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000. 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，或致电Gilead Public Affairs，电话1-800-Gilead-5或1-650-574-3000。关注X（@KitePharma）和LinkedIn社交媒体上的Kite。