24-month overall survival rate of 67 percent achieved with TALVEY® 0.8 mg/kg biweekly dosing in the Phase 1/2 MonumenTAL-1 study

在1/2期MonumenTAL-1研究中，每两周服用TALVEY®0.8 mg/kg，24个月的总生存率为67%

MADRID, June 14, 2024 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) announced today that long-term data from the Phase 1/2 MonumenTAL-1 study showed that with 20 to 30 months of median follow-up, triple-class-exposed patients with relapsed or refractory multiple myeloma (RRMM) who were treated with TALVEY® (talquetamab-tgvs) maintained high overall response rates (ORR) and durable responses, irrespective of whether they had received prior T-cell redirection therapy.1 These data, featured in a poster presentation at the 2024 European Hematology Association (EHA) Congress (Abstract #P915) demonstrate the efficacy and durability of TALVEY® when used before or after chimeric antigen receptor T-cell (CAR-T) therapy or bispecific antibody therapies in triple-class-exposed patients with RRMM.1 .

马德里，2024年6月14日/PRNewswire/--强生公司（纽约证券交易所：JNJ）今天宣布，1/2期MonumenTAL-1研究的长期数据显示，经过20至30个月的中位随访，接受TALVEY®（talquetamab tgvs）治疗的复发或难治性多发性骨髓瘤（RRMM）的三级暴露患者保持了较高的总体缓解率（ORR）和持久的反应，无论他们是否接受过T细胞重定向治疗。这些数据在2024年欧洲血液学协会（EHA）大会（摘要#P915）的海报上展示了其疗效和在三级暴露的RRMM患者中，在嵌合抗原受体T细胞（CAR-T）治疗或双特异性抗体治疗之前或之后使用TALVEY®的耐久性。

'Results from the MonumenTAL-1 study continue to show deeper response levels and a longer duration of response in patients treated with either of the approved dose options of talquetamab, while the median overall survival has yet to be reached at two years,' said Dr. Leo Rasche, attending physician on the myeloma service, University Hospital of Würzburg.* 'It is encouraging to see no notable increases in treatment-related discontinuations with this longer follow-up across cohorts.'    .

维尔茨堡大学医院骨髓瘤服务主治医师Leo Rasche博士说：“MonumenTAL-1研究的结果继续显示，接受任何一种批准剂量选择的talquetamab治疗的患者的反应水平更高，反应持续时间更长，而中位总生存期尚未在两年内达到。”“令人鼓舞的是，随着队列间更长时间的随访，与治疗相关的停药没有显着增加。”。

In MonumenTAL-1, 297 patients with no prior exposure to T-cell redirection therapy received TALVEY® at the recommended Phase 2 dose (RP2D) of 0.8 mg/kg biweekly (Q2W) (n=154) or 0.4 mg/kg weekly (QW) (n=143).1 At a median follow-up of 23.4 months, patients in the Q2W cohort demonstrated a median duration of response (DOR) of 17.5 months, with median DOR not reached in patients with complete response (CR) or better.

在MonumenTAL-1297例未接受过T细胞重定向治疗的患者中，接受了推荐的2期剂量（RP2D）为每两周0.8 mg/kg（Q2W）（n=154）或每周一次0.4 mg/kg（QW）（n=143）的TALVEY®。在中位随访23.4个月时，Q2W队列患者的中位缓解时间（DOR）为17.5个月，完全缓解（CR）或更好的患者的中位DOR未达到。

For patients in the QW arm, a median follow-up of 29.8 months showed a median DOR of 9.5 months with a median DOR of 28.6 months in patients with a CR or better. At 24 months, 67.1 percent and 60.6 percent of patients were alive from the two dosing cohorts, respectively.1 .

对于QW组患者，中位随访29.8个月，CR或更好患者的中位DOR为9.5个月，中位DOR为28.6个月。在24个月时，两个剂量组分别有67.1%和60.6%的患者存活。

At a median follow-up of 20.5 months, TALVEY® continued to show strong efficacy in patients with prior T-cell redirection therapy exposure (n=78), with 55.1 percent of patients achieving very good partial response (VGPR) or better and 57.3 percent alive at 24.2 months.1

在中位随访20.5个月时，TALVEY®在先前接受T细胞重定向治疗的患者（n=78）中继续显示出强大的疗效，55.1%的患者达到非常好的部分缓解（VGPR）或更好，57.3%在24.2个月时存活

Infection rates remained lower than in studies of B-cell maturation antigen–targeted bispecific antibodies (BsAbs), consistent with previous reports. No increase in grade 3/4 infections was observed, with longer follow-up GPRC5D-associated adverse events (AEs) led to few dose reductions and discontinuations.

感染率仍然低于B细胞成熟抗原靶向双特异性抗体（BsAbs）的研究，与以前的报道一致。没有观察到3/4级感染的增加，随访时间较长的GPRC5D相关不良事件（AE）导致剂量减少和停药很少。

One additional patient discontinued treatment due to AEs since the previous report. Weight loss, as assessed by vital signs, was evident early but stabilized and improved over time, including in patients with oral toxicities. 1.

自上次报告以来，又有一名患者因不良事件停止治疗。根据生命体征评估，体重减轻很早就很明显，但随着时间的推移，体重减轻趋于稳定和改善，包括口服毒性患者。1

Data from MonumenTAL-2 support continued durable responses at one year with investigational combination of TALVEY® and pomalidomide in patients with RRMM who had ≥ two prior lines of therapy

来自MonumenTAL-2 support的数据显示，对于先前接受过两种以上治疗的RRMM患者，TALVEY®和pomalidomide的研究组合在一年内持续产生持久反应

Longer follow-up from the Phase 1b MonumenTAL-2 study of the investigational use of TALVEY® and pomalidomide show deep responses and a manageable safety profile in patients with RRMM and support the potential to combine TALVEY® with an immunomodulatory agent (IMiD). These updated data, from the first-ever study of a regimen combining a GPRC5D-targeted therapy and an immunomodulatory agent, were featured as a poster presentation at the 2024 EHA Congress (Abstract #P911).2.

TALVEY®和pomalidomide研究性使用的1b期MonumenTAL-2研究的更长时间随访显示，RRMM患者的反应深刻，安全性可控，并支持将TALVEY®与免疫调节剂（IMiD）联合使用的潜力。这些最新数据来自首次结合GPRC5D靶向治疗和免疫调节剂的方案研究，在2024年EHA大会上作为海报展示（摘要#P911）。

Patients in the Phase 1b MonumenTAL-2 study (n=35) were treated with subcutaneous (SC) TALVEY® at the RP2D of 0.8 mg/kg (Q2W) (n=19) or 0.4 mg/kg (QW) (n=16) with step-up doses, plus 2.0 mg of oral pomalidomide daily. At a median follow-up of 16.8 months (range, 1.2-25.1), response-evaluable patients demonstrated an ORR of 88.6 percent (≥ VGPR, 80 percent).2 .

。在中位随访16.8个月（范围1.2-25.1）时，可评估反应的患者的ORR为88.6%（≥VGPR，80%）。

'With multiple dosing options and the ability to be used both before or after CAR-T therapy and BCMA bispecifics, TALVEY is an important and versatile treatment option for the treatment of relapsed or refractory multiple myeloma,' said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, at Johnson & Johnson Innovative Medicine.

强生创新医学公司（Johnson＆Johnson Innovative Medicine）副总裁、多发性骨髓瘤疾病领域负责人乔丹·谢克特（Jordan Schecter）医学博士说：“TALVEY具有多种剂量选择，并且能够在CAR-T治疗和BCMA双特异性治疗之前或之后使用，是治疗复发或难治性多发性骨髓瘤的重要且通用的治疗选择。”。

'The low rate of grade 3/4 infections seen in MonumenTAL-2 suggests the flexibility of TALVEY as a combination partner with an immunomodulatory agent for patients who continue to face limited treatment options with this complex hematologic disease.' .

“在MonumenTAL-2中观察到的3/4级感染率较低，这表明TALVEY作为免疫调节剂联合伴侣的灵活性，适用于继续面临这种复杂血液病有限治疗选择的患者。”。

At 12 months, 80.4 percent of patients who achieved a CR or better maintained their response.2 The progression-free survival (PFS) rate at 12 months was 72.6 percent.2

在12个月时，达到CR或更好的患者中有80.4%保持了反应。2 12个月时的无进展生存率（PFS）为72.6%

The most common grade 3/4 hematologic AEs were neutropenia (57.1 percent), anemia (25.7 percent), and thrombocytopenia (20 percent).2 Taste, nail, skin, and rash toxicities occurred in 85.7 percent, 68.6 percent, 74.3 percent, and 28.6 percent of patients, respectively; the majority were grade 1/2 with few discontinuations.2  Cytokine release syndrome (CRS) occurred in 74.3 percent and infections occurred in 80 percent (22.9 percent, grade 3/4) of patients.2  .

最常见的3/4级血液学AE是中性粒细胞减少症（57.1%），贫血（25.7%）和血小板减少症（20%）。2味觉，指甲，皮肤和皮疹毒性分别发生在85.7%，68.6%，74.3%和28.6%的患者中；大多数是1/2级，停药很少。2细胞因子释放综合征（CRS）发生率为74.3%，感染发生率为80%（22.9%，3/4级）。

*Dr. Leo Rasche has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

*博士。Leo Rasche为强生公司提供咨询、咨询和演讲服务；他没有收到任何媒体工作的报酬。

About TALVEY®TALVEY® (talquetamab-tgvs) received approval from the U.S. FDA in August 2023 as a first-in-class GPRC5D-targeting bispecific antibody for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.3 Since FDA approval, 1,500 patients were treated with TALVEY®.

关于TALVEY®TALVEY®（talquetamab tgvs）于2023年8月获得美国FDA批准，作为第一类靶向双特异性抗体的GPRC5D，用于治疗复发或难治性多发性骨髓瘤的成年患者，这些患者至少接受过四种治疗方案，包括蛋白酶体抑制剂，免疫调节剂和抗CD38抗体。自FDA批准以来，1500名患者接受了TALVEY®治疗。

The European Commission (EC) granted conditional marketing authorization (CMA) of TALVEY® ▼ (talquetamab-tgvs) in August 2023 as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.4.

欧盟委员会（EC）于2023年8月批准了TALVEY®▼（talquetamab tgvs）的条件营销授权（CMA），作为治疗复发和难治性多发性骨髓瘤（RRMM）成年患者的单一疗法，这些患者至少接受过三种治疗，包括免疫调节剂，蛋白酶体抑制剂和抗CD38抗体，并在最后一次治疗中证明了疾病进展。

TALVEY® is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as some healthy tissues such as epithelial cells of the skin and tongue..

TALVEY®是一种双特异性T细胞结合抗体，可与T细胞表面表达的CD3受体和G蛋白偶联受体C类5成员D（GPRC5D）结合，GPRC5D是一种新型多发性骨髓瘤靶标，在多发性骨髓瘤细胞和非恶性浆细胞以及皮肤和舌头上皮细胞等一些健康组织的表面高度表达。。

For more information, visit www.TALVEY.com.

有关更多信息，请访问www.TALVEY.com。

About MonumenTAL-1

关于纪念碑-1

MonumenTAL-1 (Phase 1: NCT03399799, Phase 2: NCT04634552) is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study involving more than 300 patients.5,6 Phase 1 evaluated the safety and efficacy of TALVEY® in adults with relapsed or refractory multiple myeloma who received three or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The study excluded patients who experienced T-cell redirection therapy within 3 months, prior Grade 3 or higher CRS related to any T-cell redirection therapy, an autologous stem cell transplant within 12 weeks, an allogenic stem cell transplant within 6 months, Eastern Cooperative Oncology Group (ECOG) performance score of 3 or higher, stroke or seizure within 6 months, CNS involvement or clinical signs of meningeal involvement of multiple myeloma, plasma cell leukemia, or active or documented history of autoimmune disease (exception of vitiligo, resolved childhood atopic dermatitis or resolved Graves' Disease that is euthyroid based on clinical and laboratory testing)..

MonumenTAL-1（第一阶段：NCT03399799，第二阶段：NCT04634552）是一项涉及300多名患者的1/2期单臂，开放标签，多中心，多中心剂量递增研究[5,6]。第一阶段评估了TALVEY®在复发或难治性多发性骨髓瘤患者中的安全性和有效性，他们接受了三种或更多种先前的治疗方案，包括蛋白酶体抑制剂，免疫调节剂和抗CD38单克隆抗体。该研究排除了在3个月内经历过T细胞重定向治疗的患者，之前与任何T细胞重定向治疗相关的3级或更高级别CRS，12周内的自体干细胞移植，6个月内的同种异体干细胞移植，东部肿瘤协作组（ECOG）表现评分为3分或更高，6个月内中风或癫痫发作，中枢神经系统受累或多发性骨髓瘤脑膜受累的临床症状，浆细胞白血病，或活动或记录的自身免疫性疾病史（白癜风除外，根据临床和实验室测试，已解决的儿童特应性皮炎或已解决的甲状腺功能正常的格雷夫斯病）。。

Phase 2 of the study evaluated the efficacy of TALVEY® in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2D), established as SC 0.4 mg/kg weekly and 0.8 mg/kg every two weeks, respectively. Efficacy was based on overall response rate (ORR) and duration of response (DOR) as assessed by an Independent Review Committee using the International Myeloma Working Group (IMWG) criteria.1.

该研究的第二阶段评估了TALVEY®在推荐的第二阶段剂量（RP2D）下对复发或难治性多发性骨髓瘤患者的疗效，分别为每周SC 0.4 mg/kg和每两周0.8 mg/kg。疗效基于总体缓解率（ORR）和缓解持续时间（DOR），由独立审查委员会使用国际骨髓瘤工作组（IMWG）标准进行评估。

About MonumenTAL-2

关于纪念碑-2

The MonumenTAL-2 (NCT05050097) study is an ongoing Phase 1 study of subcutaneous talquetamab in combination with carfilzomib, daratumumab SC, lenalidomide or pomalidomide for the treatment of patients with multiple myeloma. The primary objective of the MonumenTAL-2 study is to identify and characterize the safety of the treatment combinations.

MonumenTAL-2（NCT05050097）研究是一项正在进行的皮下他克莫布联合卡非佐米，达拉木单抗SC，来那度胺或pomalidomide治疗多发性骨髓瘤患者的1期研究。MonumenTAL-2研究的主要目的是确定和表征治疗组合的安全性。

Secondary objectives of the MonumenTAL-2 study include overall response rates, duration of response and time to response.7.

MonumenTAL-2研究的次要目标包括总体反应率，反应持续时间和反应时间。

About Multiple Myeloma

关于多发性骨髓瘤

Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.8 In multiple myeloma, these plasma cells change, spread rapidly and replace normal cells in the bone marrow with tumors.9 Multiple myeloma is the third most common blood cancer and remains an incurable disease.10 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S.

。

and more than 12,000 people will die from the disease.11 People living with multiple myeloma have a five-year relative survival rate of 59.8 percent.12 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.13,14.

超过12000人将死于这种疾病。11名多发性骨髓瘤患者的五年相对生存率为59.8%。12虽然一些被诊断为多发性骨髓瘤的患者最初没有症状，但大多数患者被诊断出的症状可能包括骨折或疼痛，红细胞计数低，疲劳，钙水平高以及肾脏问题或感染[13,14]。

TALVEY® IMPORTANT SAFETY INFORMATION

TALVEY®重要安全信息

INDICATION AND USAGE

适应症和用法

TALVEY® (talquetamab-tgvs) is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

TALVEY®（talquetamab tgvs）适用于治疗复发或难治性多发性骨髓瘤的成年患者，这些患者至少接受过四种治疗方案，包括蛋白酶体抑制剂，免疫调节剂和抗CD38单克隆抗体。

This indication is approved under accelerated approval based on 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(s).

根据响应率和响应持久性，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。

IMPORTANT SAFETY INFORMATION

重要安全信息

WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY, including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME   Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving TALVEY®. Initiate TALVEY® treatment with step-up dosing to reduce the risk of CRS.

警告：接受TALVEY®治疗的患者可能会发生细胞因子释放综合征和神经毒性，包括免疫效应细胞相关神经毒性综合征细胞因子释放综合征（CRS），包括危及生命或致命的反应。开始TALVEY®治疗，增加剂量，以降低CRS的风险。

Withhold TALVEY® until CRS resolves or permanently discontinue based on severity.   Neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), and serious and life-threatening or fatal reactions, can occur with TALVEY®. Monitor patients for signs and symptoms of neurologic toxicity including ICANS during treatment and treat promptly.

扣留TALVEY®，直到CRS解决或根据严重程度永久停止。TALVEY®可能会发生神经毒性，包括免疫效应细胞相关神经毒性综合征（ICANS），以及严重且危及生命或致命的反应。在治疗期间监测患者的神经系统毒性体征和症状，包括ICAN，并及时治疗。

Withhold or permanently discontinue TALVEY® based on severity.   Because of the risk of CRS and neurologic toxicity, including ICANS, TALVEY® is available only through a restricted program called the TECVAYLI® and TALVEY® Risk Evaluation and Mitigation Strategy (REMS). .

根据严重程度扣留或永久停用TALVEY®。由于CRS和神经系统毒性（包括ICAN）的风险，TALVEY®只能通过一项名为TECVAYLI®和TALVEY®风险评估和缓解策略（REMS）的受限计划获得。

CONTRAINDICATIONS: None.

禁忌症：无。

WARNINGS AND PRECAUTIONS

警告和注意事项

Cytokine Release Syndrome (CRS): TALVEY® can cause cytokine release syndrome, including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 76% of patients who received TALVEY® at the recommended dosages, with Grade 1 CRS occurring in 57% of patients, Grade 2 in 17%, and Grade 3 in 1.5%.

细胞因子释放综合征（CRS）：TALVEY®可引起细胞因子释放综合征，包括危及生命或致命的反应。在临床试验中，76%接受推荐剂量TALVEY®治疗的患者发生CRS，其中57%的患者发生1级CRS，17%的患者发生2级CRS，1.5%的患者发生3级CRS。

Most events occurred following step-up dose 1 (29%) or step-up dose 2 (44%) at the recommended dosages. Recurrent CRS occurred in 30% of patients. CRS occurred in 33% of patients with step-up dose 3 in the biweekly dosing schedule (N=153). CRS occurred in 30% of patients with the first 0.4 mg/kg treatment dose and in 12% of patients treated with the first 0.8 mg/kg treatment dose.

大多数事件发生在推荐剂量的递增剂量1（29%）或递增剂量2（44%）之后。30%的患者发生复发性CRS。在每两周一次的给药方案中，33%的递增剂量3患者发生CRS（N=153）。CRS发生在30%的首次0.4 mg/kg治疗剂量的患者和12%的首次0.8 mg/kg治疗剂量的患者中。

The CRS rate for both dosing schedules combined was less than 3% for each of the remaining doses in Cycle 1 and less than 3% cumulatively from Cycle 2 onward. The median time to onset of CRS was 27 (range: 0.1 to 167) hours from the last dose, and the median duration was 17 (range: 0 to 622) hours. Clinical signs and symptoms of CRS include but are not limited to pyrexia, hypotension, chills, hypoxia, headache, and tachycardia.

对于第1周期中的每个剩余剂量，两种给药方案的CRS率总和小于3%，并且从第2周期开始累积小于3%。CRS发作的中位时间为27（范围：0.1至167）小时，中位持续时间为17（范围：0至622）小时。CRS的临床体征和症状包括但不限于发热，低血压，寒战，缺氧，头痛和心动过速。

Potentially life-threatening complications of CRS may include cardiac dysfunction, acute respiratory distress syndrome, neurologic toxicity, renal and/or hepatic failure, and disseminated intravascular coagulation (DIC)..

CRS潜在的危及生命的并发症可能包括心功能不全，急性呼吸窘迫综合征，神经系统毒性，肾和/或肝衰竭以及弥散性血管内凝血（DIC）。。

Initiate therapy with step-up dosing and administer pre-treatment medications (corticosteroids, antihistamine, and antipyretics) prior to each dose of TALVEY® in the step-up dosing schedule to reduce the risk of CRS. Monitor patients following administration accordingly. In patients who experience CRS, pre-treatment medications should be administered prior to the next TALVEY® dose..

在递增剂量时间表中的每剂TALVEY®之前，开始递增剂量的治疗，并服用治疗前药物（皮质类固醇，抗组胺药和退热药），以降低CRS的风险。相应地监测给药后的患者。对于经历CRS的患者，应在下一次TALVEY®剂量之前服用治疗前药物。。

Counsel patients to seek medical attention should signs or symptoms of CRS occur. At the first sign of CRS, immediately evaluate patient for hospitalization and institute treatment with supportive care based on severity, and consider further management per current practice guidelines. Withhold TALVEY® until CRS resolves or permanently discontinue based on severity..

如果出现CRS的体征或症状，建议患者就医。在出现CRS的第一个迹象时，立即评估患者的住院情况，并根据严重程度进行支持性治疗，并考虑根据当前的实践指南进行进一步管理。扣留TALVEY®直到CRS解决或根据严重程度永久停止。。

Neurologic Toxicity including ICANS: TALVEY® can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), including fatal reactions. In the clinical trial, neurologic toxicity occurred in 55% of patients who received the recommended dosages, with Grade 3 or 4 neurologic toxicity occurring in 6% of patients.

包括ICAN在内的神经系统毒性：TALVEY®可引起严重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（ICANS），包括致命反应。在临床试验中，接受推荐剂量的患者中有55%发生神经系统毒性，6%的患者发生3级或4级神经系统毒性。

The most frequent neurologic toxicities were headache (20%), encephalopathy (15%), sensory neuropathy (14%), and motor dysfunction (10%)..

最常见的神经系统毒性是头痛（20%），脑病（15%），感觉神经病（14%）和运动功能障碍（10%）。。

ICANS was reported in 9% of 265 patients where ICANS was collected and who received the recommended dosages. Recurrent ICANS occurred in 3% of patients. Most patients experienced ICANS following step-up dose 1 (3%), step-up dose 2 (3%), step-up dose 3 of the biweekly dosing schedule (1.8%), or the initial treatment dose of the weekly dosing schedule (2.6%) (N=156) or the biweekly dosing schedule (3.7%) (N=109).

在收集ICAN并接受推荐剂量的265名患者中，有9%报告了ICAN。复发性ICAN发生在3%的患者中。大多数患者在递增剂量1（3%），递增剂量2（3%），双周给药方案的递增剂量3（1.8%）或每周给药方案的初始治疗剂量后经历ICAN（2.6%）（N=156）或双周给药方案（3.7%）（N=109）。

The median time to onset of ICANS was 2.5 (range: 1 to 16) days after the most recent dose with a median duration of 2 (range: 1 to 22) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS. Clinical signs and symptoms of ICANS may include but are not limited to confusional state, depressed level of consciousness, disorientation, somnolence, lethargy, and bradyphrenia..

ICANS发病的中位时间为最近一次剂量后2.5（范围：1至16）天，中位持续时间为2（范围：1至22）天。ICANS的发作可以与CRS同时发生，在CRS消退后或在没有CRS的情况下。ICANS的临床体征和症状可能包括但不限于困惑状态，意识水平低下，定向障碍，嗜睡，嗜睡和精神迟钝。。

Monitor patients for signs and symptoms of neurologic toxicity during treatment and treat promptly. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient and provide supportive care based on severity. Withhold or permanently discontinue TALVEY® based on severity and consider further management per current practice guidelines.

在治疗过程中监测患者的神经系统毒性体征和症状，并及时治疗。在出现包括ICAN在内的神经系统毒性的第一个迹象时，立即评估患者并根据严重程度提供支持性护理。根据严重程度扣留或永久停用TALVEY®，并考虑根据当前实践指南进行进一步管理。

[see Dosage and Administration (2.5)]..

[见剂量和给药（2.5）]。。

Due to the potential for neurologic toxicity, patients receiving TALVEY® are at risk of depressed level of consciousness. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery during the step-up dosing schedule and for 48 hours after completion of the step-up dosing schedule, and in the event of new onset of any neurological symptoms, until symptoms resolve..

由于潜在的神经毒性，接受TALVEY®治疗的患者有意识水平低下的风险。建议患者在递增给药计划期间和递增给药计划完成后48小时内，以及在新出现任何神经系统症状的情况下，不要驾驶或操作重型或潜在危险的机器，直到症状消失。。

TECVAYLI® and TALVEY® REMS: TALVEY® is available only through a restricted program under a REMS, called the TECVAYLI® and TALVEY® REMS because of the risks of CRS and neurologic toxicity, including ICANS.

TECVAYLI®和TALVEY®REMS:TALVEY®只能通过REMS下的受限程序获得，称为TECVAYLI®和TALVEY®REMS，因为存在CRS和神经系统毒性的风险，包括ICAN。

Further information about the TECVAYLI® and TALVEY® REMS program is available at www.TEC-TALREMS.com or by telephone at 1-855-810-8064.

有关TECVAYLI®和TALVEY®REMS计划的更多信息，请访问www.TEC-TALREMS.com或致电1-855-810-8064。

Oral Toxicity and Weight Loss: TALVEY® can cause oral toxicities, including dysgeusia, dry mouth, dysphagia, and stomatitis. In the clinical trial, 80% of patients had oral toxicity, with Grade 3 occurring in 2.1% of patients who received the recommended dosages. The most frequent oral toxicities were dysgeusia (49%), dry mouth (34%), dysphagia (23%), and ageusia (18%).

口服毒性和体重减轻：TALVEY®可引起口服毒性，包括味觉障碍，口干，吞咽困难和口腔炎。在临床试验中，80%的患者有口服毒性，接受推荐剂量的患者中有2.1%发生3级。最常见的口服毒性是味觉障碍（49%），口干（34%），吞咽困难（23%）和衰老（18%）。

The median time to onset of oral toxicity was 15 (range: 1 to 634) days, and the median time to resolution to baseline was 43 (1 to 530) days. Oral toxicity did not resolve to baseline in 65% of patients..

口服毒性发作的中位时间为15（范围：1至634）天，解决基线的中位时间为43（1至530）天。65%的患者口服毒性未达到基线水平。。

TALVEY® can cause weight loss. In the clinical trial, 62% of patients experienced weight loss of 5% or greater, regardless of having an oral toxicity, including 28% of patients with Grade 2 (10% or greater) weight loss and 2.7% of patients with Grade 3 (20% or greater) weight loss. The median time to onset of Grade 2 or higher weight loss was 67 (range: 6 to 407) days, and the median time to resolution was 50 (range: 1 to 403) days.

TALVEY®可导致体重减轻。在临床试验中，62%的患者体重减轻5%或更高，无论是否有口服毒性，包括28%的2级（10%或更高）体重减轻患者和2.7%的3级患者（20%或更高）体重减轻。2级或更高体重减轻的中位发病时间为67（范围：6至407）天，中位消退时间为50（范围：1至403）天。

Weight loss did not resolve in 57% of patients who reported weight loss..

57%报告体重减轻的患者体重减轻没有解决。。

Monitor patients for signs and symptoms of oral toxicity. Counsel patients to seek medical attention should signs or symptoms of oral toxicity occur and provide supportive care as per current clinical practice, including consultation with a nutritionist. Monitor weight regularly during therapy. Evaluate clinically significant weight loss further.

监测患者口服毒性的体征和症状。如果出现口服毒性的迹象或症状，建议患者就医，并根据当前的临床实践提供支持性护理，包括咨询营养师。在治疗期间定期监测体重。进一步评估临床上显着的体重减轻。

Withhold TALVEY® or permanently discontinue based on severity..

扣留TALVEY®或根据严重程度永久停止使用。。

Infections: TALVEY® can cause infections, including life-threatening or fatal infections.  Serious infections occurred in 16% of patients, with fatal infections in 1.5% of patients. Grade 3 or 4 infections occurred in 17% of patients. The most common serious infections reported were bacterial infection (8%), which included sepsis and COVID-19 (2.7%)..

感染：TALVEY®可引起感染，包括危及生命或致命的感染。16%的患者发生严重感染，1.5%的患者发生致命感染。17%的患者发生3或4级感染。报告的最常见的严重感染是细菌感染（8%），其中包括败血症和新型冠状病毒肺炎（2.7%）。。

Monitor patients for signs and symptoms of infection prior to and during treatment with TALVEY® and treat appropriately. Administer prophylactic antimicrobials according to local guidelines. Withhold or consider permanently discontinuing TALVEY® as recommended, based on severity.

在使用TALVEY®治疗之前和期间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。根据严重程度，根据建议扣留或考虑永久停用TALVEY®。

Cytopenias: TALVEY® can cause cytopenias, including neutropenia and thrombocytopenia. In the clinical trial, Grade 3 or 4 decreased neutrophils occurred in 35% of patients, and Grade 3 or 4 decreased platelets occurred in 22% of patients who received TALVEY®. The median time to onset for Grade 3 or 4 neutropenia was 22 (range: 1 to 312) days, and the median time to resolution to Grade 2 or lower was 8 (range: 1 to 79) days.

血细胞减少症：TALVEY®可引起血细胞减少症，包括中性粒细胞减少症和血小板减少症。在临床试验中，35%的患者发生3级或4级中性粒细胞减少，22%接受TALVEY®治疗的患者发生3级或4级血小板减少。3级或4级中性粒细胞减少症的中位发病时间为22（范围：1至312）天，解决2级或更低级别的中位时间为8（范围：1至79）天。

The median time to onset for Grade 3 or 4 thrombocytopenia was 12 (range: 2 to 183) days, and the median time to resolution to Grade 2 or lower was 10 (range: 1 to 64) days. Monitor complete blood counts during treatment and withhold TALVEY® as recommended, based on severity..

3级或4级血小板减少症的中位发病时间为12（范围：2至183）天，解决2级或更低级别的中位时间为10（范围：1至64）天。在治疗期间监测全血细胞计数，并根据严重程度根据建议扣留TALVEY®。。

Skin Toxicity: TALVEY® can cause serious skin reactions, including rash, maculo-papular rash, erythema, and erythematous rash. In the clinical trial, skin reactions occurred in 62% of patients, with grade 3 skin reactions in 0.3%. The median time to onset was 25 (range: 1 to 630) days. The median time to improvement to grade 1 or less was 33 days..

皮肤毒性：TALVEY®可引起严重的皮肤反应，包括皮疹、斑丘疹、红斑和红斑性皮疹。在临床试验中，62%的患者发生皮肤反应，3级皮肤反应发生率为0.3%。中位发病时间为25（范围：1至630）天。改善至1级或以下的中位时间为33天。。

Monitor for skin toxicity, including rash progression. Consider early intervention and treatment to manage skin toxicity.  Withhold TALVEY® as recommended based on severity.

监测皮肤毒性，包括皮疹进展。考虑早期干预和治疗以控制皮肤毒性。根据严重程度的建议扣留TALVEY®。

Hepatotoxicity: TALVEY® can cause hepatotoxicity. Elevated ALT occurred in 33% of patients, with grade 3 or 4 ALT elevation occurring in 2.7%; elevated AST occurred in 31% of patients, with grade 3 or 4 AST elevation occurring in 3.3%. Grade 3 or 4 elevations of total bilirubin occurred in 0.3% of patients.

肝毒性：TALVEY®可引起肝毒性。33%的患者发生ALT升高，3级或4级ALT升高发生率为2.7%；AST升高发生在31%的患者中，3级或4级AST升高发生在3.3%。0.3%的患者总胆红素升高3或4级。

Liver enzyme elevation can occur with or without concurrent CRS..

肝酶升高可以在有或没有并发CRS的情况下发生。。

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold TALVEY® or consider permanent discontinuation of TALVEY®, based on severity [see Dosage and Administration (2.5)].

根据临床指示，在基线和治疗期间监测肝酶和胆红素。根据严重程度，停止使用TALVEY®或考虑永久停用TALVEY®[见剂量和给药（2.5）]。

Embryo-Fetal Toxicity: Based on its mechanism of action, TALVEY® may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with TALVEY® and for 3 months after the last dose..

胚胎-胎儿毒性：根据其作用机制，TALVEY®给孕妇服用时可能会造成胎儿伤害。告知孕妇对胎儿的潜在风险。建议有生殖潜力的女性在使用TALVEY®治疗期间和最后一剂后3个月内使用有效的避孕措施。。

Adverse Reactions: The most common adverse reactions (≥20%) are pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension, and headache.

不良反应：最常见的不良反应（≥20%）是发热，CRS，味觉障碍，指甲紊乱，肌肉骨骼疼痛，皮肤病，皮疹，疲劳，体重下降，口干，干燥，吞咽困难，上呼吸道感染，腹泻，低血压和头痛。

The most common Grade 3 or 4 laboratory abnormalities (≥30%) are lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, and hemoglobin decreased.

最常见的3或4级实验室异常（≥30%）是淋巴细胞计数减少，中性粒细胞计数减少，白细胞减少和血红蛋白减少。

Please read full Prescribing Information, including Boxed WARNING, for TALVEY®.

请阅读TALVEY®的完整处方信息，包括盒装警告。

About Johnson & Johnson

关于强生公司

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

在强生公司，我们相信健康就是一切。我们在医疗保健创新方面的优势使我们能够建立一个‡预防，治疗和治愈复杂疾病的世界，‡治疗更智能，侵入性更小，‡解决方案更个性化。通过我们在创新医学和医学技术方面的专业知识，我们拥有独特的优势，可以在今天的所有医疗保健解决方案中进行创新，以实现明天的突破，并深刻影响人类的健康。

Learn more at https://www.jnj.com/ or at www.janssen.com/johnson-johnson-innovative-medicine. Follow us at @JanssenUS and @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are both Johnson & Johnson companies. Source: Johnson & Johnson.

了解更多信息，请访问https://www.jnj.com/或访问www.janssen.com/johnson-johnson-innovative-medicine。请访问@JanssenUS和@JNJInnovMed。Janssen Research&Development，LLC和Janssen Biotech，Inc.都是强生公司。资料来源：强生公司。

Cautions Concerning Forward-Looking Statements

关于前瞻性陈述的注意事项

This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of TALVEY® (talquetamab-tgvs). The reader is cautioned not to rely on these forward-looking statements.

本新闻稿包含1995年《私人证券诉讼改革法案》中定义的“前瞻性声明”，涉及产品开发以及TALVEY®（talquetamab tgvs）的潜在益处和治疗影响。提醒读者不要依赖这些前瞻性陈述。

These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc., and/or Johnson & Johnson.

这些声明基于当前对未来事件的预期。如果基础假设不准确或出现已知或未知的风险或不确定性，实际结果可能与Janssen Research＆Development，LLC，Janssen Biotech，Inc。和/或Johnson＆Johnson的预期和预测有很大差异。

Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment.

风险和不确定性包括但不限于：产品研发固有的挑战和不确定性，包括临床成功和获得监管批准的不确定性；商业成功的不确定性；制造困难和延误；竞争，包括竞争对手取得的技术进步、新产品和专利；专利面临的挑战；导致产品召回或监管行动的产品功效或安全问题；医疗保健产品和服务购买者行为和支出模式的变化；适用法律法规的变更，包括全球医疗保健改革；以及医疗保健成本控制的趋势。

A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned 'Cautionary Note Regarding Forward-Looking Statements' and 'Item 1A. Risk Factors,' and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission.

有关这些风险、不确定性和其他因素的更多列表和描述，请参见强生公司截至2023年12月31日的10-K表年度报告，包括标题为“关于前瞻性声明的警示说明”和“项目1A”的章节。“风险因素”，以及强生公司随后在10-Q表上的季度报告以及向美国证券交易委员会提交的其他文件中。

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1 Rasche, L et al., Long-term efficacy and safety results from the Phase 1/2 MonumenTAL-1 study of talquetamab, a GPRC5DxCD3 bispecific antibody, in patients with relapsed/refractory multiple myeloma. 2024 European Hematology Association Hybrid Congress. Accessed June  2024.2 Searle, E et al., Talquetamab, a GPRC5dxCD3 bispecific antibody, in combination with pomalidomide in patients with relapsed/refractory multiple myeloma: safety and efficacy results from the Phase 1b MonumenTAL-2 study.

1 Rasche，L等人，talquetamab（一种GPRC5DxCD3双特异性抗体）在复发/难治性多发性骨髓瘤患者中的1/2期纪念性1期研究的长期疗效和安全性结果。2024年欧洲血液学协会混合大会。2024年6月访问。Searle，E等人，Talquetamab，一种GPRC5dxCD3双特异性抗体，联合pomalidomide治疗复发/难治性多发性骨髓瘤：1b期MonumenTAL-2研究的安全性和有效性结果。

2024 European Hematology Association Hybrid Congress. Accessed June 2024.3 TALVEY® U.S. Prescribing Information, August 2023.4 European Medicines Agency. TALVEY Summary of Product Characteristics. August 2023.5 ClinicalTrials.gov Identifier NCT03399799. https://clinicaltrials.gov/ct2/show/NCT03399799.

2024年欧洲血液学协会混合大会。2024.3年6月访问TALVEY®美国处方信息，2023.4年8月访问欧洲药品管理局。TALVEY产品特性总结。2023.5年8月ClinicalTrials.gov标识符NCT03399799。https://clinicaltrials.gov/ct2/show/NCT03399799.

Accessed: June 2024.6 ClinicalTrials.gov Identifier NCT04634552. https://clinicaltrials.gov/ct2/show/NCT04634552 Accessed: June 2024.7 ClinicalTrials.gov Identifier NCT05050097. https://clinicaltrials.gov/study/NCT05050097. Accessed: June 2024.8 Rajkumar SV. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management.

访问日期：June 2024.6 ClinicalTrials.gov标识符NCT04634552。https://clinicaltrials.gov/ct2/show/NCT04634552访问日期：June 2024.7 ClinicalTrials.gov标识符NCT05050097。https://clinicaltrials.gov/study/NCT05050097.访问日期：2024年6月.8 Rajkumar SV。多发性骨髓瘤：2020年诊断，风险分层和管理更新。

Am J Hematol. 2020;95(5):548-5672020;95(5):548-567. http://www.ncbi.nlm.nih.gov/pubmed/32212178. Accessed: June 2024.9 National Cancer Institute. Plasma Cell Neoplasms. Available at: https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq. Accessed: June 2024.10 Multiple myeloma. City of Hope, 2022.

Am J Hematol。2020年；95（5）：548-5672020；95（5）：548-567。http://www.ncbi.nlm.nih.gov/pubmed/32212178.访问时间：2024年6月.9国家癌症研究所。浆细胞肿瘤。网址：https://www.cancer.gov/types/myeloma/patient/myeloma-treatment-pdq.访问时间：2024年6月.10多发性骨髓瘤。希望之城，2022年。

Multiple Myeloma: Causes, Symptoms & Treatments. Available at:. https://www.cancercenter.com/cancer-types/multiple-myeloma. Accessed: June 2024.11 American Cancer Society. Key Statistics About Multiple Myeloma. Available at: https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~:text=Multiple%20myeloma%20is%20a%20relatively,men.

多发性骨髓瘤：原因，症状和治疗。网址：。https://www.cancercenter.com/cancer-types/multiple-myeloma.访问时间：2024年6月11日美国癌症协会。关于多发性骨髓瘤的关键统计数据。网址：https://www.cancer.org/cancer/multiple-myeloma/about/key-statistics.html#:~：text=多发性骨髓瘤相对来说是男性。

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