SOMERSET, N.J.--(BUSINESS WIRE)--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global leader in cell therapy, announced today that new and updated data from the CARTITUDE clinical development program evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) for patients with multiple myeloma will be presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 2024 European Hematology Association’s (EHA) Hybrid Congress..

新泽西州萨默塞特市（商业新闻短讯）--细胞治疗领域的全球领导者联想生物技术公司（纳斯达克：LEGN）（联想生物技术）今天宣布，将在2024年美国临床肿瘤学会（ASCO）年会和2024年欧洲血液学协会（EHA）混合大会上介绍CARVYKTI®（ciltacabtagene autoleucel；cilta cel）评估多发性骨髓瘤患者的最新数据。。

Data from Cohort D of the Phase 2 CARTITUDE-2 study investigating a single infusion of CARVYKTI® with or without lenalidomide maintenance in patients who achieved less than complete response after autologous stem cell transplant (ASCT) frontline therapy will be presented for the first time in an oral presentation at ASCO and in an encore oral presentation at EHA..

来自第二阶段CARTITUDE-2研究队列D的数据将首次在ASCO的口头报告和EHA的encore口头报告中介绍，该研究调查了自体干细胞移植（ASCT）一线治疗后未达到完全缓解的患者单次输注CARVYKTI®并维持或不维持来那度胺的情况。。

Data from the subgroup analysis of the Phase 3 CARTITUDE-4 study of CARVYKTI® versus two standard therapies in patients with functional high-risk multiple myeloma after one prior line of treatment will be presented in an oral presentation at ASCO. Additionally, the results of the CARTITUDE-4 subgroup analysis by cytogenetic risk will be shared at EHA in a poster session..

来自CARVYKTI®3期CARTITUDE-4研究的亚组分析数据与功能性高危多发性骨髓瘤患者的两种标准疗法相比，在一种先前的治疗方案后，将在ASCO的口头报告中提供。此外，通过细胞遗传学风险进行的Cartitute-4亚组分析的结果将在EHA的海报会议上分享。。

“The results of the CARTITUDE clinical development program with CARVYKTI will provide significant insights about the broad range of patients who will benefit from this one-time treatment,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We are excited to share our latest data with the hematology and oncology communities as we work to give new hope to patients and strive to one day develop a cure for multiple myeloma.”.

Legend Biotech首席执行官黄英博士说：“CARVYKTI的CARTITUDE临床开发项目的结果将为广泛的患者提供重要的见解，这些患者将从这种一次性治疗中受益。”。“我们很高兴与血液学和肿瘤学界分享我们的最新数据，因为我们努力为患者带来新的希望，并努力有一天开发出多发性骨髓瘤的治疗方法。”。

ASCO Presentations (May 31-June 4, 2024)

ASCO演讲（2024年5月31日至6月4日）

Abstract No.

摘要编号。

Title

标题

Information

信息

Abstract #7504

摘要#7504

Oral Presentation

口头陈述

Ciltacabtagene autoleucel vs standard of care in patients with functional high-risk multiple myeloma: CARTITUDE-4 subgroup analysis

功能性高危多发性骨髓瘤患者的Ciltacabtagene autoleucel与标准治疗：Cartitute-4亚组分析

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

课程名称：血液系统恶性肿瘤-浆细胞恶液质

Date/Time: June 3, 2024, 4:12 – 4:24 p.m. CDT

日期/时间：2024年6月3日，CDT下午4:12–4:24

Location: Hall D1

地点：D1厅

Abstract #7505 Oral Presentation

摘要#7505口头陈述

Efficacy and safety of ciltacabtagene autoleucel ± lenalidomide maintenance in patients with multiple myeloma who had suboptimal response to frontline autologous stem cell transplant: CARTITUDE-2 cohort D

对一线自体干细胞移植反应欠佳的多发性骨髓瘤患者维持西他卡宾-自体亮氨酸±来那度胺的疗效和安全性：Cartitute-2队列D

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

课程名称：血液系统恶性肿瘤-浆细胞恶液质

Date/Time: June 3, 2024, 4:24 – 4:36 p.m. CDT

日期/时间：2024年6月3日，CDT下午4:24–4:36

Location: Hall D1

地点：D1厅

Abstract #7535 Poster

摘要#7535海报

Ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma: CARTITUDE-2 cohort A expansion subgroup

来那度胺难治性多发性骨髓瘤患者的Ciltacabtagene autoleucel:Cartitute-2队列A扩展亚组

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

课程名称：血液系统恶性肿瘤-浆细胞恶液质

Poster Bd#: 172

海报Bd#：172

Date/Time: June 3, 2024, 9:00 a.m. -12:00 p.m. CDT

日期/时间：2024年6月3日，CDT上午9:00-下午12:00

Location: Hall A

地点：A厅

EHA Presentations (June 13-16, 2024)

EHA演讲（2024年6月13日至16日）

Abstract No.

摘要编号。

Title

标题

Information

信息

Abstract #S205 Oral Presentation

摘要#S205口头报告

Encore: Ciltacabtagene autoleucel ± lenalidomide maintenance in patients with multiple myeloma who had suboptimal response to frontline autologous stem cell transplant: CARTITUDE-2 cohort D

Encore：对一线自体干细胞移植反应欠佳的多发性骨髓瘤患者的Ciltacabtagene autoleucel±来那度胺维持治疗：Cartitute-2队列D

Date/Time: June 15, 2024, 16:30-16:45 CEST

日期/时间：2024年6月15日16:30-16:45 CEST

Location: Hall Picasso

地点：霍尔毕加索

Abstract #P959 Poster

摘要#P959海报

Encore: Ciltacabtagene autoleucel vs standard of care in patients with functional high-risk multiple myeloma: CARTITUDE-4 subgroup analysis

Encore:Ciltacabtagene autoleucel与功能性高危多发性骨髓瘤患者的标准治疗：Cartitute-4亚组分析

Date/Time: June 14, 2024, 18:00-19:00 CEST

日期/时间：2024年6月14日18:00-19:00 CEST

Location: Hall 7

地点：7号展厅

Abstract #P978 Poster

摘要#P978海报

Ciltacabtagene autoleucel vs standard of care in lenalidomide-refractory multiple myeloma: Phase 3 CARTITUDE-4 subgroup analysis by cytogenetic risk

来那度胺难治性多发性骨髓瘤的西他卡宾自体白血病与标准治疗：细胞遗传学风险的3期CARTITUDE-4亚组分析

Date/Time: June 14, 2024, 18:00-19:00 CEST

日期/时间：2024年6月14日18:00-19:00 CEST

Location: Hall 7

地点：7号展厅

Abstract #P967 Poster

摘要#P967海报

Comparative effectiveness of ciltacabtagene autoleucel from the CARTITUDE-4 trial vs real-world physician’s choice of therapy from the flatiron registry in lenalidomide-refractory multiple myeloma

来自CARTITUDE-4试验的ciltacabtagene autoleucel与来自flatiron登记处的现实医生选择来那度胺难治性多发性骨髓瘤治疗的比较有效性

Date/Time: June 14, 2024,18:00-19:00 CEST

日期/时间：2024年6月14日18:00-19:00 CEST

Location: Hall 7

地点：7号展厅

Abstract #P863 Poster

摘要#P863海报

Clinical biomarkers associated with progression free survival to ciltacabtagene autoleucel in Chinese patients with relapsed/refractory multiple myeloma from​ CARTIFAN-1 STUDY

中国复发/难治性多发性骨髓瘤患者中与西他卡本自体白血病无进展生存相关的临床生物标志物​ CARTIFAN-1研究

Date/Time: June 14, 2024, 18:00-19:00 CEST

日期/时间：2024年6月14日18:00-19:00 CEST

Location: Hall 7

地点：7号展厅

CARVYKTI® IMPORTANT SAFETY INFORMATION

CARVYKTI®重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, PROLONGED and RECURRENT CYTOPENIA, and SECONDARY HEMATOLOGICAL MALIGNANCIES

警告：细胞因子释放综合征，神经系统毒性，HLH/MAS，长期和复发性血细胞减少症以及继发性血液系统恶性肿瘤

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

用CARVYKTI®治疗后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。请勿将CARVYKTI®用于活动性感染或炎症性疾病患者。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。。

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI ®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI ®.

免疫效应细胞相关神经毒性综合征（ICANS）可能致命或危及生命，发生在用CARVYKTI®治疗后，包括在CRS发作之前，与CRS同时发生，在CRS消退后或在没有CRS的情况下。监测用CARVYKTI®治疗后的神经系统事件。

Provide supportive care and/or corticosteroids as needed..

根据需要提供支持性护理和/或皮质类固醇。。

Parkinsonism and Guillain-Barré syndrome (GBS) and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI ®.

在用CARVYKTI®治疗后，发生了帕金森病和格林-巴利综合征（GBS）及其相关并发症，导致致命或危及生命的反应。

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI ®. HLH/MAS can occur with CRS or neurologic toxicities.

CARVYKTI®治疗后的患者发生噬血细胞性淋巴组织细胞增多症/巨噬细胞活化综合征（HLH/MAS），包括致命和危及生命的反应。HLH/MAS可伴有CRS或神经系统毒性。

Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI ®.

在用CARVYKTI®治疗后，发生了长时间和/或复发性血细胞减少症，伴有出血和感染，并且需要进行干细胞移植以恢复造血功能。

Secondary hematological malignancies, including myelodysplastic syndrome and acute myeloid leukemia, have occurred in patients following treatment with CARVYKTI ®. T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI ®..

CARVYKTI®治疗后的患者发生了继发性血液系统恶性肿瘤，包括骨髓增生异常综合征和急性髓性白血病。用BCMA和CD19定向的基因修饰的自体T细胞免疫疗法（包括CARVYKTI®）治疗血液系统恶性肿瘤后，发生了T细胞恶性肿瘤。。

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

CARVYKTI®只能通过风险评估和缓解策略（REMS）下的受限计划（称为CARVYKTI®REMS计划）获得。

WARNINGS AND PRECAUTIONS

警告和注意事项

INCREASED EARLY MORTALITY - In CARTITUDE-4, a (1:1) randomized controlled trial, there was a numerically higher percentage of early deaths in patients randomized to the CARVYKTI® treatment arm compared to the control arm. Among patients with deaths occurring within the first 10 months from randomization, a greater proportion (29/208; 14%) occurred in the CARVYKTI® arm compared to (25/211; 12%) in the control arm.

早期死亡率增加-在CARTITUDE-4（1:1）随机对照试验中，与对照组相比，随机分配到CARVYKTI®治疗组的患者的早期死亡率在数值上更高。在随机分组的前10个月内发生死亡的患者中，CARVYKTI®组发生的比例（29/208；14%）高于对照组（25/211；12%）。

Of the 29 deaths that occurred in the CARVYKTI® arm within the first 10 months of randomization, 10 deaths occurred prior to CARVYKTI® infusion, and 19 deaths occurred after CARVYKTI® infusion. Of the 10 deaths that occurred prior to CARVYKTI® infusion, all occurred due to disease progression, and none occurred due to adverse events.

在随机分组的前10个月内，CARVYKTI®组发生了29例死亡，其中10例死亡发生在CARVYKTI®输注之前，19例死亡发生在CARVYKTI®输注之后。在CARVYKTI®输注之前发生的10例死亡中，所有死亡都是由于疾病进展引起的，没有一例是由于不良事件引起的。

Of the 19 deaths that occurred after CARVYKTI® infusion, 3 occurred due to disease progression, and 16 occurred due to adverse events. The most common adverse events were due to infection (n=12)..

在CARVYKTI®输注后发生的19例死亡中，3例因疾病进展而发生，16例因不良事件而发生。最常见的不良事件是由于感染（n=12）。。

CYTOKINE RELEASE SYNDROME (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® for RRMM in the CARTITUDE-1 & 4 studies (N=285), CRS occurred in 84% (238/285), including ≥ Grade 3 CRS (ASCT 2019) in 4% (11/285) of patients.

用CARVYKTI®治疗后发生细胞因子释放综合征（CRS），包括致命或危及生命的反应。在Cartitute-1＆4研究（N=285）中接受CARVYKTI®治疗RRMM的患者中，CRS发生率为84%（238/285），其中≥3级CRS（ASCT 2019）发生率为4%（11/285）。

Median time to onset of CRS, any grade, was 7 days (range: 1 to 23 days). CRS resolved in 82% with a median duration of 4 days (range: 1 to 97 days). The most common manifestations of CRS in all patients combined (≥ 10%) included fever (84%), hypotension (29%) and aspartate aminotransferase increased (11%).

CRS发病的中位时间为7天（范围：1至23天）。CRS消退率为82%，中位持续时间为4天（范围：1至97天）。所有合并（≥10%）的患者中CRS最常见的表现包括发热（84%），低血压（29%）和天冬氨酸转氨酶升高（11%）。

Serious events that may be associated with CRS include pyrexia, hemophagocytic lymphohistiocytosis, respiratory failure, disseminated intravascular coagulation, capillary leak syndrome, and supraventricular and ventricular tachycardia. CRS occurred in 78% of patients in CARTITUDE-4 (3% Grade 3 to 4) and in 95% of patients in CARTITUDE-1 (4% Grade 3 to 4).

可能与CRS相关的严重事件包括发热，噬血细胞性淋巴组织细胞增多症，呼吸衰竭，弥散性血管内凝血，毛细血管渗漏综合征以及室上性和室性心动过速。78%的Cartitute-4患者（3%为3-4级）和95%的Cartitute-1患者（4%为3-4级）发生CRS。

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS.

根据临床表现确定CRS。评估和治疗发烧、缺氧和低血压的其他原因。据报道，CRS与HLH/MAS的发现有关，这些综合征的生理学可能重叠。HLH/MAS是一种潜在的威胁生命的疾病。尽管接受了治疗，但仍有CRS或难治性CRS进行性症状的患者，请评估HLH/MAS的证据。

Please see Section 5.4; Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS)..

请参阅第5.4节；噬血细胞性淋巴组织细胞增生症（HLH）/巨噬细胞活化综合征（MAS）。。

Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI®.

在输注CARVYKTI®之前，确保至少有两剂托珠单抗可用。

Of the 285 patients who received CARVYKTI® in clinical trials, 53% (150/285) patients received tocilizumab; 35% (100/285) received a single dose, while 18% (50/285) received more than 1 dose of tocilizumab. Overall, 14% (39/285) of patients received at least one dose of corticosteroids for treatment of CRS..

在临床试验中接受CARVYKTI®的285名患者中，53%（150/285）患者接受了托珠单抗治疗；35%（100/285）接受单剂量，而18%（50/285）接受超过1剂托珠单抗。总体而言，14%（39/285）的患者接受了至少一剂皮质类固醇治疗CRS。。

Monitor patients at least daily for 10 days following CARVYKTI® infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids..

在REMS认证的医疗机构输注CARVYKTI®后，至少每天监测患者CRS的体征和症状10天。输注后至少4周监测患者CRS的体征或症状。在CRS的第一个迹象时，立即用支持治疗，托珠单抗或托珠单抗和皮质类固醇进行治疗。。

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

如果CRS的体征或症状随时出现，建议患者立即就医。

NEUROLOGIC TOXICITIES, which may be severe, life-threatening, or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, GBS, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities.

在用CARVYKTI®治疗后，可能会发生严重，危及生命或致命的神经系统毒性。神经系统毒性包括ICANS，具有帕金森氏症，GBS，免疫介导的脊髓炎，周围神经病和颅神经麻痹体征和症状的神经系统毒性。就这些神经系统毒性的体征和症状以及其中一些毒性发作的延迟性质向患者提供咨询。

Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time..

指示患者在任何时候出现任何这些神经系统毒性的体征或症状时，立即寻求医疗护理以进行进一步评估和管理。。

Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies for RRMM, one or more neurologic toxicities occurred in 24% (69/285), including ≥ Grade 3 cases in 7% (19/285) of patients. Median time to onset was 10 days (range: 1 to 101) with 63/69 (91%) of cases developing by 30 days. Neurologic toxicities resolved in 72% (50/69) of patients with a median duration to resolution of 23 days (range: 1 to 544).

在Cartitute-1＆4 RRMM研究中接受CARVYKTI®治疗的患者中，24%（69/285）发生一种或多种神经系统毒性，其中7%（19/285）患者≥3级。中位发病时间为10天（范围：1至101），其中63/69（91%）的病例在30天内发展。72%（50/69）的患者神经系统毒性消退，中位持续时间为23天（范围：1至544）。

Of patients developing neurotoxicity, 96% (66/69) also developed CRS. Subtypes of neurologic toxicities included ICANS in 13%, peripheral neuropathy in 7%, cranial nerve palsy in 7%, parkinsonism in 3%, and immune mediated myelitis in 0.4% of the patients..

在发生神经毒性的患者中，96%（66/69）也发生了CRS。神经毒性的亚型包括ICANS 13%，周围神经病变7%，颅神经麻痹7%，帕金森病3%，免疫介导的脊髓炎0.4%。。

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients receiving CARVYKTI® may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS.

免疫效应细胞相关神经毒性综合征（ICANS）：接受CARVYKTI®治疗的患者在接受CARVYKTI®治疗后可能会出现致命或危及生命的ICANS，包括在CRS发作之前，与CRS同时发生，在CRS消退后或在没有CRS的情况下。

Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, ICANS occurred in 13% (36/285), including Grade ≥3 in 2% (6/285) of the patients. Median time to onset of ICANS was 8 days (range: 1 to 28 days). ICANS resolved in 30 of 36 (83%) of patients with a median time to resolution of 3 days (range: 1 to 143 days).

在Cartitute-1＆4研究中接受CARVYKTI®的患者中，ICAN发生率为13%（36/285），其中2%（6/285）的患者≥3级。ICANS发病的中位时间为8天（范围：1至28天）。ICANS在36名患者中有30名（83%）得到了解决，中位解决时间为3天（范围：1至143天）。

Median duration of ICANS was 6 days (range: 1 to 1229 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. Of patients with ICANS, 97% (35/36) had CRS. The onset of ICANS occurred during CRS in 69% of patients, before and after the onset of CRS in 14% of patients respectively..

所有患者的ICANS中位持续时间为6天（范围：1至1229天），包括死亡或数据截止时正在发生神经系统事件的患者。在ICANS患者中，97%（35/36）患有CRS。69%的患者在CRS期间发生ICANS，14%的患者在CRS发作之前和之后发生ICANS。。

Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3) and in 23% of patients in CARTITUDE-1 (3% Grade 3). The most frequent ≥2% manifestations of ICANS included encephalopathy (12%), aphasia (4%), headache (3%), motor dysfunction (3%), ataxia (2%), and sleep disorder (2%) [see Adverse Reactions (6.1)]..

免疫效应细胞相关神经毒性综合征（ICANS）发生在Cartitute-4（0.5%3级）的7%患者和Cartitute-1（3%3级）的23%患者中。ICANS最常见的≥2%表现包括脑病（12%），失语症（4%），头痛（3%），运动功能障碍（3%），共济失调（2%）和睡眠障碍（2%）[见不良反应（6.1）]。。

Monitor patients at least daily for 10 days following CARVYKTI® infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed [see Dosage and Administration (2.3)]..

在REMS认证的医疗机构输注CARVYKTI®后，至少每天监测患者10天，以了解ICAN的体征和症状。排除ICANS症状的其他原因。输注后至少4周监测患者的ICAN体征或症状，并及时治疗。神经系统毒性应根据需要给予支持治疗和/或皮质类固醇[见剂量和给药（2.3）]。。

Parkinsonism: Neurologic toxicity with parkinsonism has been reported in clinical trials of CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, parkinsonism occurred in 3% (8/285), including Grade ≥ 3 in 2% (5/285) of the patients. Median time to onset of parkinsonism was 56 days (range: 14 to 914 days).

帕金森病：CARVYKTI®的临床试验报道了帕金森病的神经毒性。在Cartitute-1＆4研究中接受CARVYKTI®治疗的患者中，帕金森病发生率为3%（8/285），其中2%（5/285）的患者≥3级。帕金森病发作的中位时间为56天（范围：14至914天）。

Parkinsonism resolved in 1 of 8 (13%) of patients with a median time to resolution of 523 days. Median duration of parkinsonism was 243.5 days (range: 62 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off. The onset of parkinsonism occurred after CRS for all patients and after ICANS for 6 patients..

帕金森病在8名患者中有1名（13%）得到解决，中位解决时间为523天。所有患者的帕金森病中位持续时间为243.5天（范围：62至720天），包括那些在死亡或数据截止时正在发生神经系统事件的患者。帕金森病的发作发生在所有患者的CRS后和ICANS后6名患者。。

Parkinsonism occurred in 1% of patients in CARTITUDE-4 (no Grade 3 to 4) and in 6% of patients in CARTITUDE-1 (4% Grade 3 to 4).

Cartitute-4（无3至4级）患者中有1%发生帕金森病，Cartitute-1（4%3至4级）患者中有6%发生帕金森病。

Manifestations of parkinsonism included movement disorders, cognitive impairment, and personality changes. Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment..

帕金森病的表现包括运动障碍，认知障碍和人格改变。监测患者帕金森病的体征和症状，这些症状可能会延迟发作，并通过支持性护理措施进行管理。用于治疗帕金森病的药物在CARVYKTI®治疗后改善或解决帕金森病症状的疗效信息有限。。

Guillain-Barré Syndrome: A fatal outcome following GBS occurred following treatment with CARVYKTI® despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances, and polyradiculoneuritis..

吉兰-巴雷综合征：尽管用静脉注射免疫球蛋白治疗，但在用CARVYKTI®治疗后，GBS发生致命后果。报告的症状包括与GBS的Miller-Fisher变异，脑病，运动无力，言语障碍和多发性神经根性尿道炎一致的症状。。

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

监测GBS。评估患有GBS周围神经病变的患者。根据GBS的严重程度，考虑采用支持性护理措施以及免疫球蛋白和血浆置换治疗GBS。

Immune Mediated Myelitis: Grade 3 myelitis occurred 25 days following treatment with CARVYKTI® in CARTITUDE-4 in a patient who received CARVYKTI® as subsequent therapy. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin.

免疫介导的脊髓炎：在接受CARVYKTI®作为后续治疗的患者中，CARVYKTI®在Cartitute-4治疗后25天发生3级脊髓炎。报告的症状包括下肢和下腹感觉减退，括约肌控制受损。使用皮质类固醇和静脉注射免疫球蛋白可改善症状。

Myelitis was ongoing at the time of death from other cause..

脊髓炎在其他原因死亡时正在进行中。。

Peripheral Neuropathy occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, peripheral neuropathy occurred in 7% (21/285), including Grade ≥3 in 1% (3/285) of the patients. Median time to onset of peripheral neuropathy was 57 days (range: 1 to 914 days).

用CARVYKTI®治疗后发生周围神经病变。在Cartitute-1＆4研究中接受CARVYKTI®的患者中，周围神经病变发生率为7%（21/285），其中1%（3/285）的患者≥3级。周围神经病变发作的中位时间为57天（范围：1至914天）。

Peripheral neuropathy resolved in 11 of 21 (52%) of patients with a median time to resolution of 58 days (range: 1 to 215 days). Median duration of peripheral neuropathy was 149.5 days (range: 1 to 692 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off..

21名患者中有11名（52%）的周围神经病变消退，中位消退时间为58天（范围：1至215天）。所有患者的周围神经病变中位持续时间为149.5天（范围：1至692天），包括死亡或数据截止时正在发生神经系统事件的患者。。

Peripheral neuropathies occurred in 7% of patients in CARTITUDE-4 (0.5% Grade 3 to 4) and in 7% of patients in CARTITUDE-1 (2% Grade 3 to 4). Monitor patients for signs and symptoms of peripheral neuropathies. Patients who experience peripheral neuropathy may also experience cranial nerve palsies or GBS..

Cartitute-4患者中有7%（3至4级为0.5%）和Cartitute-1患者中有7%（3至4级为2%）发生周围神经病变。监测患者周围神经病变的体征和症状。患有周围神经病变的患者也可能患有颅神经麻痹或GBS。。

Cranial Nerve Palsies occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, cranial nerve palsies occurred in 7% (19/285), including Grade ≥3 in 1% (1/285) of the patients. Median time to onset of cranial nerve palsies was 21 days (range: 17 to 101 days).

用CARVYKTI®治疗后发生颅神经麻痹。在Cartitute-1＆4研究中接受CARVYKTI®治疗的患者中，颅神经麻痹发生率为7%（19/285），其中1%（1/285）的患者≥3级。颅神经麻痹发作的中位时间为21天（范围：17至101天）。

Cranial nerve palsies resolved in 17 of 19 (89%) of patients with a median time to resolution of 66 days (range: 1 to 209 days). Median duration of cranial nerve palsies was 70 days (range: 1 to 262 days) in all patients including those with ongoing neurologic events at the time of death or data cut-off.

19例患者中有17例（89%）颅神经麻痹得到缓解，中位缓解时间为66天（范围：1至209天）。所有患者的颅神经麻痹中位持续时间为70天（范围：1至262天），包括死亡或数据截止时正在发生神经系统事件的患者。

Cranial nerve palsies occurred in 9% of patients in CARTITUDE-4 (1% Grade 3 to 4) and in 3% of patients in CARTITUDE-1 (1% Grade 3 to 4)..

Cartitute-4（1%3至4级）患者中有9%发生颅神经麻痹，Cartitute-1（1%3至4级）患者中有3%发生颅神经麻痹。。

The most frequent cranial nerve affected was the 7th cranial nerve. Additionally, cranial nerves III, V, and VI have been reported to be affected.

受影响最常见的颅神经是第7颅神经。此外，据报道颅神经III，V和VI受到影响。

Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

监测患者颅神经麻痹的体征和症状。根据体征和症状的严重程度和进展，考虑使用全身皮质类固醇进行治疗。

HEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (HLH)/MACROPHAGE ACTIVATION SYNDROME (MAS): Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, HLH/MAS occurred in 1% (3/285) of patients. All events of HLH/MAS had onset within 99 days of receiving CARVYKTI®, with a median onset of 10 days (range: 8 to 99 days) and all occurred in the setting of ongoing or worsening CRS.

噬血细胞性淋巴组织细胞增多症（HLH）/巨噬细胞活化综合征（MAS）：在CARTITUDE-1和4研究中接受CARVYKTI®的患者中，1%（3/285）的患者发生HLH/MAS。所有HLH/MAS事件均在接受CARVYKTI®治疗后99天内发生，中位发病时间为10天（范围：8至99天），均发生在持续或恶化的CRS中。

The manifestations of HLH/MAS included hyperferritinemia, hypotension, hypoxia with diffuse alveolar damage, coagulopathy and hemorrhage, cytopenia, and multi-organ dysfunction, including renal dysfunction and respiratory failure..

HLH/MAS的表现包括高铁蛋白血症，低血压，缺氧伴弥漫性肺泡损伤，凝血病和出血，血细胞减少和多器官功能障碍，包括肾功能不全和呼吸衰竭。。

Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematologic parameters in patients with HLH/MAS and transfuse per institutional guidelines. Fatal cases of HLH/MAS occurred following treatment with CARVYKTI®.

发生HLH/MAS的患者严重出血的风险增加。根据机构指南监测HLH/MAS患者的血液学参数和输血。用CARVYKTI®治疗后发生致命的HLH/MAS病例。

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

HLH是一种危及生命的疾病，如果不及早发现和治疗，死亡率很高。HLH/MAS的治疗应按照机构标准进行。

CARVYKTI® REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS.

CARVYKTI®REMS：由于CRS和神经系统毒性的风险，CARVYKTI®只能通过风险评估和缓解策略（REMS）下的受限程序获得，称为CARVYKTI®REMS。

Further information is available at https://www.carvyktirems.com or 1-844-672-0067.

更多信息请访问https://www.carvyktirems.com或1-844-672-0067。

PROLONGED AND RECURRENT CYTOPENIAS: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, Grade 3 or higher cytopenias not resolved by day 30 following CARVYKTI® infusion occurred in 62% (176/285) of the patients and included thrombocytopenia 33% (94/285), neutropenia 27% (76/285), lymphopenia 24% (67/285) and anemia 2% (6/285).

长期和复发性血细胞减少症：患者在淋巴清除化疗和CARVYKTI®输注后可能表现出长期和复发性血细胞减少症。在Cartitute-1＆4研究中接受CARVYKTI®的患者中，62%（176/285）的患者在输注CARVYKTI®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33%（94/285），中性粒细胞减少症27%（76/285），淋巴细胞减少症24%（67/285）和贫血2%（6/285）。

After Day 60 following CARVYKTI® infusion 22%, 20%, 5%, and 6% of patients had a recurrence of Grade 3 or 4 lymphopenia, neutropenia, thrombocytopenia, and anemia respectively, after initial recovery of their Grade 3 or 4 cytopenia. Seventy-seven percent (219/285) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia.

CARVYKTI®输注后第60天，22%，20%，5%和6%的患者在3级或4级血细胞减少症初始恢复后分别复发3级或4级淋巴细胞减少症，中性粒细胞减少症，血小板减少症和贫血。在3级或4级血细胞减少症初步恢复后，77%（219/285）的患者有1次，2次或3次或更多的3级或4级血细胞减少症复发。

Sixteen and 25 patients had Grade 3 or 4 neutropenia and thrombocytopenia, respectively, at the time of death..

死亡时分别有16名和25名患者出现3级或4级中性粒细胞减少症和血小板减少症。。

Monitor blood counts prior to and after CARVYKTI® infusion. Manage cytopenias with growth factors and blood product transfusion support according to local institutional guidelines.

在CARVYKTI®输注前后监测血细胞计数。根据当地机构指南，通过生长因子和血液制品输血支持管理血细胞减少症。

INFECTIONS: CARVYKTI® should not be administered to patients with active infection or inflammatory disorders. Severe, life-threatening, or fatal infections, occurred in patients after CARVYKTI® infusion.

感染：CARVYKTI®不应用于活动性感染或炎症性疾病患者。CARVYKTI®输注后患者发生严重，危及生命或致命的感染。

Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, infections occurred in 57% (163/285), including ≥Grade 3 in 24% (69/285) of patients. Grade 3 or 4 infections with an unspecified pathogen occurred in 12%, viral infections in 6%, bacterial infections in 5%, and fungal infections in 1% of patients.

在Cartitute-1＆4研究中接受CARVYKTI®的患者中，感染发生率为57%（163/285），其中24%（69/285）的患者≥3级。未指定病原体的3或4级感染发生率为12%，病毒感染发生率为6%，细菌感染发生率为5%，真菌感染发生率为1%。

Overall, 5% (13/285) of patients had Grade 5 infections, 2.5% of which were due to COVID-19. Patients treated with CARVYKTI® had an increased rate of fatal COVID-19 infections compared to the standard therapy arm..

总体而言，5%（13/285）的患者患有5级感染，其中2.5%是由于新型冠状病毒引起的。与标准治疗组相比，接受CARVYKTI®治疗的患者致命性COVID-19感染率增加。。

Monitor patients for signs and symptoms of infection before and after CARVYKTI® infusion and treat patients appropriately. Administer prophylactic, pre-emptive, and/or therapeutic antimicrobials according to the standard institutional guidelines. Febrile neutropenia was observed in 5% of patients after CARVYKTI® infusion and may be concurrent with CRS.

在CARVYKTI®输注前后监测患者的感染体征和症状，并对患者进行适当治疗。根据标准机构指南管理预防性，先发制人和/或治疗性抗菌药物。CARVYKTI®输注后，5%的患者出现发热性中性粒细胞减少症，可能与CRS同时发生。

In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care, as medically indicated. Counsel patients on the importance of prevention measures. Follow institutional guidelines for the vaccination and management of immunocompromised patients with COVID-19..

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，液体和其他支持治疗。就预防措施的重要性向患者提供咨询。遵循免疫功能低下的新型冠状病毒肺炎患者的疫苗接种和管理机构指南。。

Viral Reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients with hypogammaglobulinemia. Perform screening for Cytomegalovirus (CMV), HBV, hepatitis C virus (HCV), human immunodeficiency virus (HIV), or any other infectious agents if clinically indicated in accordance with clinical guidelines before collection of cells for manufacturing.

病毒再激活：低丙种球蛋白血症患者可能发生乙型肝炎病毒（HBV）再激活，在某些情况下会导致暴发性肝炎，肝衰竭和死亡。如果在收集细胞进行生产之前根据临床指南进行临床指示，则对巨细胞病毒（CMV），HBV，丙型肝炎病毒（HCV），人类免疫缺陷病毒（HIV）或任何其他传染源进行筛查。

Consider antiviral therapy to prevent viral reactivation per local institutional guidelines/clinical practice..

根据当地机构指南/临床实践，考虑抗病毒治疗以防止病毒再激活。。

HYPOGAMMAGLOBULINEMIA: can occur in patients receiving treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypogammaglobulinemia adverse event was reported in 36% (102/285) of patients; laboratory IgG levels fell below 500mg/dl after infusion in 93% (265/285) of patients..

低丙种球蛋白血症：接受CARVYKTI®治疗的患者可能发生。在Cartitute-1＆4研究中接受CARVYKTI®的患者中，36%（102/285）的患者报告了低丙种球蛋白血症不良事件；93%（265/285）的患者输注后实验室IgG水平降至500mg/dl以下。。

Hypogammaglobulinemia either as an adverse reaction or laboratory IgG level below 500mg/dl, after infusion occurred in 94% (267/285) of patients treated. Fifty-six percent (161/285) of patients received intravenous immunoglobulin (IVIG) post CARVYKTI® for either an adverse reaction or prophylaxis.

94%（267/285）接受治疗的患者输注后发生低丙种球蛋白血症，无论是不良反应还是实验室IgG水平低于500mg/dl。56%（161/285）的患者在CARVYKTI®后接受静脉注射免疫球蛋白（IVIG），用于不良反应或预防。

Monitor immunoglobulin levels after treatment with CARVYKTI® and administer IVIG for IgG <400 mg/dL. Manage per local institutional guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

用CARVYKTI®治疗后监测免疫球蛋白水平，并给予IVIG治疗IgG<400 mg/dL。按照当地机构指南进行管理，包括感染预防措施和抗生素或抗病毒预防措施。

Use of Live Vaccines: The safety of immunization with live viral vaccines during or following CARVYKTI® treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during CARVYKTI® treatment, and until immune recovery following treatment with CARVYKTI®..

活疫苗的使用：尚未研究在CARVYKTI®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CARVYKTI®治疗期间以及在用CARVYKTI®治疗后免疫恢复之前，不建议至少6周内接种活病毒疫苗。。

HYPERSENSITIVITY REACTIONS occurred following treatment with CARVYKTI®. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, hypersensitivity reactions occurred in 5% (13/285), all of which were ≤ Grade 2. Manifestations of hypersensitivity reactions included flushing, chest discomfort, tachycardia, wheezing, tremor, burning sensation, non-cardiac chest pain, and pyrexia..

用CARVYKTI®治疗后发生超敏反应。在CARTITUDE-1和4研究中接受CARVYKTI®治疗的患者中，发生超敏反应的比例为5%（13/285），均≤2级。超敏反应的表现包括潮红，胸部不适，心动过速，喘息，震颤，烧灼感，非心源性胸痛和发热。。

Serious hypersensitivity reactions, including anaphylaxis, may be due to the dimethyl sulfoxide (DMSO) in CARVYKTI®. Patients should be carefully monitored for 2 hours after infusion for signs and symptoms of severe reaction. Treat promptly and manage patients appropriately according to the severity of the hypersensitivity reaction..

严重的超敏反应，包括过敏反应，可能是由于CARVYKTI®中的二甲基亚砜（DMSO）。输注后应仔细监测患者2小时的严重反应体征和症状。根据超敏反应的严重程度，及时治疗并适当管理患者。。

SECONDARY MALIGNANCIES: Patients treated with CARVYKTI® may develop secondary malignancies. Among patients receiving CARVYKTI® in the CARTITUDE-1 & 4 studies, myeloid neoplasms occurred in 5% (13/285) of patients (9 cases of myelodysplastic syndrome, 3 cases of acute myeloid leukemia, and 1 case of myelodysplastic syndrome followed by acute myeloid leukemia).

继发性恶性肿瘤：接受CARVYKTI®治疗的患者可能会发生继发性恶性肿瘤。在CARTITUDE-1＆4研究中接受CARVYKTI®治疗的患者中，5%（13/285）的患者发生了髓系肿瘤（9例骨髓增生异常综合征，3例急性髓系白血病，1例骨髓增生异常综合征，其次是急性髓系白血病）。

The median time to onset of myeloid neoplasms was 447 days (range: 56 to 870 days) after treatment with CARVYKTI®. Ten of these 13 patients died following the development of myeloid neoplasms; 2 of the 13 cases of myeloid neoplasm occurred after initiation of subsequent antimyeloma therapy. Cases of myelodysplastic syndrome and acute myeloid leukemia have also been reported in the post-marketing setting.

用CARVYKTI®治疗后，骨髓肿瘤发病的中位时间为447天（范围：56至870天）。这13例患者中有10例死于髓系肿瘤；13例骨髓瘤中有2例发生在随后开始抗骨髓瘤治疗后。上市后也有骨髓增生异常综合征和急性骨髓性白血病的病例报道。

T-cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies, including CARVYKTI®. Mature T-cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusions and may include fatal outcomes..

用BCMA和CD19定向的基因修饰的自体T细胞免疫疗法（包括CARVYKTI®）治疗血液系统恶性肿瘤后，发生了T细胞恶性肿瘤。成熟的T细胞恶性肿瘤，包括CAR阳性肿瘤，可能在输注后数周内出现，并可能包括致命的后果。。

Monitor life-long for secondary malignancies. In the event that a secondary malignancy occurs, contact Janssen Biotech, Inc. at 1-800-526-7736 for reporting and to obtain instructions on collection of patient samples.

终身监测继发性恶性肿瘤。如果发生继发性恶性肿瘤，请致电1-800-526-7736联系Janssen Biotech，Inc.进行报告并获取患者样本收集说明。

EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Due to the potential for neurologic events, including altered mental status, seizures, neurocognitive decline, or neuropathy, patients receiving CARVYKTI® are at risk for altered or decreased consciousness or coordination in the 8 weeks following CARVYKTI® infusion.

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，癫痫发作，神经认知能力下降或神经病，接受CARVYKTI®的患者在CARVYKTI®输注后8周内有意识或协调能力改变或降低的风险。

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, and in the event of new onset of any neurologic toxicities..

建议患者不要驾驶和从事危险的职业或活动，例如在初始阶段操作重型或潜在危险的机器，以及在新出现任何神经系统毒性的情况下。。

ADVERSE REACTIONS

不良反应

The most common nonlaboratory adverse reactions (incidence greater than 20%) are pyrexia, cytokine release syndrome, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections-pathogen unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.

最常见的非实验室不良反应（发生率大于20%）是发热，细胞因子释放综合征，低丙种球蛋白血症，低血压，肌肉骨骼疼痛，疲劳，感染病原体不明，咳嗽，寒战，腹泻，恶心，脑病，食欲下降，上呼吸道感染，头痛，心动过速，头晕，呼吸困难，水肿，病毒感染，凝血病，便秘和呕吐。

The most common Grade 3 or 4 laboratory adverse reactions (incidence greater than or equal to 50%) include lymphopenia, neutropenia, white blood cell decreased, thrombocytopenia, and anemia..

最常见的3级或4级实验室不良反应（发生率大于或等于50%）包括淋巴细胞减少，中性粒细胞减少，白细胞减少，血小板减少和贫血。。

Please read full Prescribing Information, including Boxed Warning, for CARVYKTI®.

请阅读CARVYKTI®的完整处方信息，包括盒装警告。

ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)

关于CARVYKTI® （CILTACABTAGEN AUTOLEUCEL；CILTA-CEL）

Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA.

Ciltacabtagene autoleucel是一种BCMA指导的基因修饰的自体T细胞免疫疗法，它涉及用编码嵌合抗原受体（CAR）的转基因重新编程患者自身的T细胞，该转基因可识别并消除表达BCMA的细胞。cilta cel CAR蛋白具有两种靶向BCMA的单结构域抗体，旨在赋予针对人BCMA的高亲和力。

Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1.

在与表达BCMA的细胞结合后，CAR促进T细胞活化，扩增和消除靶细胞。

In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen), a Johnson & Johnson company, to develop and commercialize cilta-cel. In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma.

2017年12月，Legend Biotech与强生公司Janssen Biotech，Inc.（Janssen）签订了全球独家许可和合作协议，以开发和商业化cilta cel。2022年2月，美国食品和药物管理局（FDA）批准cilta-cel以CARVYKTI®品牌治疗复发或难治性多发性骨髓瘤。

In April 2024, cilta-cel was approved for the second-line treatment of patients with relapsed/refractory myeloma who have received at least one prior line of therapy including a proteasome inhibitor, an immunomodulatory agent, and are refractory to lenalidomide..

2024年4月，cilta-cel被批准用于复发/难治性骨髓瘤患者的二线治疗，这些患者至少接受过一种治疗方案，包括蛋白酶体抑制剂，一种免疫调节剂，并且对来那度胺无效。。

In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma. In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®. Cilta-cel was granted Breakthrough Therapy Designation in the U.S.

2022年5月，欧盟委员会（EC）授予CARVYKTI®有条件上市许可，用于治疗复发和难治性多发性骨髓瘤的成年人。2022年9月，日本厚生劳动省（MHLW）批准了CARVYKTI®。Cilta cel在美国被授予突破性治疗称号。

in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020.

2019年12月和2020年8月在中国。此外，cilta cel于2019年4月获得了欧盟委员会的优先药物（PRIME）指定。Cilta cel还于2019年2月从美国FDA，2020年2月从欧盟委员会以及2020年6月从日本药品和医疗器械管理局（PMDA）获得了孤儿药的指定。

In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment..

2022年3月，欧洲药品管理局（European Medicines Agency）孤儿药品委员会（Committee for Orphan Medical Products）一致建议，根据临床数据，维持cilta cel的孤儿指定，证明治疗后完全缓解率得到改善和持续。。

ABOUT CARTITUDE-2

关于CARTON-2

CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings (Cohorts A, B, C, D, E, F, G, H).2

Cartitute-2（NCT04133636）是一项正在进行的2期多队列研究，评估cilta-cel在各种临床环境（队列A，B，C，D，E，F，G，H）中的安全性和有效性

ABOUT CARTITUDE-4

关于章程-4

CARTITUDE-4 (NCT04181827) is an ongoing, international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, including a PI and an IMiD.3.

Cartitute-4（NCT04181827）是一项正在进行的国际随机开放标签3期研究，评估cilta-cel与pomalidomide，硼替佐米和地塞米松（PVd）或daratumumab，pomalidomide和地塞米松（DPd）在成人复发和来那度胺难治性多发性骨髓瘤患者中的疗效和安全性，这些患者接受了一到三种治疗方案，包括PI和IMiD。

ABOUT MULTIPLE MYELOMA

关于多发性骨髓瘤

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.4 In 2024, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.5 While some patients with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6.

多发性骨髓瘤是一种不可治愈的血癌，始于骨髓，其特征是浆细胞过度增殖[4]。2024年，据估计，超过35000人将被诊断出患有多发性骨髓瘤，超过12000人将在美国死于该疾病[5]。虽然一些多发性骨髓瘤患者最初没有症状，但大多数患者被诊断出的症状可能包括骨骼问题，低血细胞计数，钙升高，肾脏问题或感染[6]。

ABOUT LEGEND BIOTECH

关于LEGEND BIOTECH

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogeneic chimeric antigen receptor T-cell, gamma-delta T cell (gd T) and natural killer (NK) cell-based immunotherapy.

Legend Biotech是一家全球生物技术公司，致力于治疗和一天治疗威胁生命的疾病。总部位于新泽西州萨默塞特，我们正在开发各种技术平台的先进细胞疗法，包括自体和同种异体嵌合抗原受体T细胞，γδT细胞（gd T）和基于自然杀伤（NK）细胞的免疫疗法。

From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of cutting-edge therapeutics for patients worldwide..

从我们在世界各地的三个研发基地，我们应用这些创新技术，为世界各地的患者探索尖端疗法。。

Learn more at www.legendbiotech.com and follow us on X (formerly Twitter) and LinkedIn.

请访问www.legendbiotech.com了解更多信息，并在X（前Twitter）和LinkedIn上关注我们。

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

关于前瞻性陈述的警示说明

Statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to Legend Biotech’s strategies and objectives; statements relating to CARVYKTI®, including Legend Biotech’s expectations for CARVYKTI® and its therapeutic potential; statements related to the potential results from ongoing studies in the CARTITUDE clinical development program; and the potential benefits of Legend Biotech’s product candidates.

本新闻稿中关于未来预期、计划和前景的声明，以及关于非历史事实的任何其他声明，构成1995年《私人证券诉讼改革法》所指的“前瞻性声明”。这些声明包括但不限于与联想生物技术的战略和目标有关的声明；有关CARVYKTI®的声明，包括联想生物技术公司对CARVYKTI®的期望及其治疗潜力；与Cartitute临床开发计划正在进行的研究的潜在结果有关的声明；以及Legend Biotech候选产品的潜在益处。

The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

“预期”，“相信”，“继续”，“可能”，“估计”，“预期”，“打算”，“可能”，“计划”，“潜力”，“预测”，“项目”，“应该”，“目标”，“将会”，“将会”和类似的表达旨在识别前瞻性陈述，尽管并非所有前瞻性陈述都包含这些识别词。

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectu.

由于各种重要因素的影响，实际结果可能与此类前瞻性声明所显示的结果存在重大差异。联想生物技术的预期可能会受到新药品开发中涉及的不确定性等因素的影响；意外的临床试验结果，包括对现有临床数据或意外的新临床数据进行额外分析的结果；意外的监管行动或延迟，包括要求额外的安全性和/或有效性数据或数据分析，或一般的政府监管；由于我们的第三方合作伙伴采取的行动或未能采取行动而导致的意外延误；Legend Biotech的专利或其他专有知识受到挑战而产生的不确定性。

REFERENCES

参考文献

1 CARVYKTI™ Prescribing Information. Horsham, PA: Janssen Biotech, Inc.

1 CARVYKTI™处方信息。宾夕法尼亚州霍沙姆：杨森生物技术公司。

2 ClinicalTrials.gov. A Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against B-cell Maturation Antigen (BCMA) in Participants With Multiple Myeloma (CARTITUDE-2). Available at: https://clinicaltrials.gov/study/NCT04133636. Last accessed Nov 2023.

2 ClinicalTrials.gov。一项针对多发性骨髓瘤（Cartitute-2）参与者针对B细胞成熟抗原（BCMA）的嵌合抗原受体T细胞（CAR-T）疗法JNJ-68284528的研究。网址：https://clinicaltrials.gov/study/NCT04133636.上次访问时间为2023年11月。

3 ClinicalTrials.Gov. A Study Comparing JNJ-68284528, a CAR-T Therapy Directed Against B-cell Maturation Antigen (BCMA), Versus Pomalidomide, Bortezomib and Dexamethasone (PVd) or Daratumumab, Pomalidomide and Dexamethasone (DPd) in Participants With Relapsed and Lenalidomide-Refractory Multiple Myeloma (CARTITUDE-4).

3临床试验。Gov.一项比较JNJ-68284528（一种针对B细胞成熟抗原（BCMA）的CAR-T疗法）与Pomalidomide，硼替佐米和地塞米松（PVd）或Daratumumab，Pomalidomide和地塞米松（DPd）在复发和来那度胺难治性多发性骨髓瘤（Cartitute-4）参与者中的比较研究。

https://www.clinicaltrials.gov/study/NCT04181827. Accessed March 2024..

https://www.clinicaltrials.gov/study/NCT04181827.2024年3月访问。。

4 American Cancer Society. ”What is Multiple Myeloma?”. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html. Accessed March 2024.

4美国癌症协会。”什么是多发性骨髓瘤。网址：https://www.cancer.org/cancer/types/multiple-myeloma/about/what-is-multiple-myeloma.html.2024年3月访问。

5 American Cancer Society. “Key Statistics About Multiple Myeloma.” Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed March 2024

5美国癌症协会。“关于多发性骨髓瘤的关键统计数据”。网址：https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html.2024年3月访问

6 American Cancer Society. Multiple myeloma: early detection, diagnosis, and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf. Accessed March 2023.

6美国癌症协会。多发性骨髓瘤：早期发现，诊断和分期。网址：https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf.2023年3月访问。