New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing1

新的MajesTEC-1数据显示，中位反应持续时间为24个月，反应加深，包括改用双周剂量的患者1

Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of TECVAYLI®

MajesTEC-1和OPTec研究的单独分析首次强调了TECVAYLI®门诊管理的机会

CHICAGO, June 3, 2024 /PRNewswire/ -- Johnson & Johnson today announced longer-term data from the pivotal Phase 1/2 MajesTEC-1 study of TECVAYLI® (teclistamab-cqyv) showing deep and durable responses in patients with relapsed or refractory multiple myeloma (RRMM) who are triple-class exposed (TCE)a and who previously received three or more prior lines of therapy, including in patients who switched to less frequent dosing (Abstract #7540).1 These data were featured at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in a poster presentation.1 .

芝加哥，2024年6月3日/PRNewswire/--强生公司今天宣布了TECVAYLI®（teclistamab cqyv）关键性1/2期MajesTEC-1研究的长期数据，显示复发或难治性多发性骨髓瘤（RRMM）患者的深度和持久反应，这些患者是三级暴露（TCE）a，之前接受过三种或更多种治疗方案，包括改用较不频繁剂量的患者（摘要#7540）[1]。这些数据在2024年美国临床肿瘤学会（ASCO）年会上以海报形式展示。

Additional presentations highlight the potential for outpatient step-up administration with prophylactic tocilizumab from the MajesTEC-1 study (Abstract #7517) and the first-in-class Phase 2 OPTec study (Abstract #7528), as well as first results from the subgroup analysis of patients with high-risk (HR) features that will be presented at the 2024 European Hematology Association (EHA) Congress (Abstract #923).2,3,4 The safety run-in MajesTEC-7 study in frontline TECVAYLI® administration (Abstract #7506) will also be presented at ASCO.4 .

其他演讲强调了MajesTEC-1研究（摘要#7517）和第一个2期OPTec研究（摘要#7528）中预防性托珠单抗门诊加强给药的潜力，以及将在2024年欧洲血液学协会（EHA）大会（摘要#923）上提交的高危（HR）患者亚组分析的初步结果。2,3,4 MajesTEC-7前线TECVAYLI®管理安全运行研究（摘要#7506）也将在ASCOL上提交零点四。

'With the longest follow-up of any bispecific antibody, teclistamab demonstrates continued deep and durable responses observed in patients with relapsed or refractory multiple myeloma who have limited treatment options,' said Niels van de Donk, M.D., Professor of Hematology at Amsterdam University Medical Centers, and principal study investigator.* 'The results of the MajesTEC-1 study indicate the potential of teclistamab to transform the treatment paradigm, and clinical studies are investigating whether teclistamab may be a pivotal advancement for improved care and management in the broader patient population.'.

阿姆斯特丹大学医学中心血液学教授、首席研究者尼尔斯·范德唐克（Niels van de Donk，M.D.）说：“在任何双特异性抗体的随访时间最长的情况下，teclistamab在治疗选择有限的复发或难治性多发性骨髓瘤患者中表现出持续的深度和持久的反应。MajesTEC-1研究的结果表明，teclistamab有可能改变治疗模式，临床研究正在调查teclistamab是否可能是改善更广泛患者群体护理和管理的关键进步。”。

Results from the MajesTEC-1 study show that, at a median follow-up of 30.4 months, patients treated with TECVAYLI® at the recommended Phase 2 dose (RP2D)b (n=165) demonstrated an overall response rate (ORR) of 63 percent, with responses continuing to deepen and 46 percent of patients achieving a complete response (CR) or better.1 For patients with a CR or better, mDOR, mPFS, and mOS were not yet reached, and estimated 30-month DOR, PFS, and OS rates were 61, 61 and 74 percent, respectively.1 Patients who achieved a partial response or better after a minimum of four cycles of therapy (Phase 1), or maintained a CR or better for a minimum of six months (Phase 2) per protocol, had the option to switch to biweekly dosing (every two weeks) (Q2W).1 Additionally, 37 out of 38 patients who switched to Q2W dosing maintained responses.1.

MajesTEC-1研究的结果显示，在中位随访30.4个月时，以推荐的2期剂量（RP2D）b（n=165）接受TECVAYLI®治疗的患者的总有效率（ORR）为63%，反应持续加深，46%的患者达到完全缓解（CR）或更好。1对于CR或更好的患者，mDOR，mPFS和mOS尚未达到，估计30个月的DOR，PFS和OS率分别为61%，61%和74%。1在至少四个治疗周期（第一阶段）后达到部分缓解或更好的患者，或维持每个方案至少六个月（第二阶段）的CR或更好，可以选择转换为每两周一次（每两周一次）（Q2W）[1]。此外，38例转换为Q2W剂量的患者中有37例保持了反应。

The safety profile remained consistent, with a notable decrease in new onset of severe infections over time.1 Adverse events (AEs) included neutropenia (any grade, 72 percent; grade 3/4, 66 percent), anemia (any grade, 55 percent; grade 3/4, 38 percent), thrombocytopenia (any grade, 42 percent; grade 3/4, 23 percent), lymphopenia (any grade, 36 percent; grade 3/4, 35 percent), and infections (any grade, 79 percent; grade 3/4, 55 percent).1 Of 22 grade 5 infections, 18 were due to COVID-19.1 The decrease in new-onset grade 3 or greater infections may be due to switching to Q2W dosing or other factors such as implementing the use of intravenous immunoglobulin.1 .

安全性保持一致，随着时间的推移，新发严重感染的发生率显着下降。1不良事件（AE）包括中性粒细胞减少症（任何级别，72%；3/4级，66%），贫血（任何级别，55%；3/4级，38%），血小板减少症（任何级别，42%；3/4级，23%），淋巴细胞减少症（任何级别，36%；3/4级，35%）和感染（任何级别，79%；3/4级，55%）。在22例5级感染中，有18例是由于新型冠状病毒引起的。1新发3级或更高级别感染的减少可能是由于改用Q2W剂量或其他因素，如实施静脉注射免疫球蛋白的使用。

'Over the past two years, TECVAYLI has helped over 10,000 patients with relapsed or refractory multiple myeloma,' said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. 'Through robust clinical data and real-world evidence, and by leveraging our team's expertise, we're working relentlessly to address unmet needs for patients with myeloma and drive the development of new treatment options for use across the treatment paradigm, including in the frontline setting.'.

强生创新医学公司肿瘤学研究与开发副总裁、医学博士雷切尔·科博斯（RachelKobos）说，过去两年来，TECVAYLI帮助了10000多名复发或难治性多发性骨髓瘤患者通过强大的临床数据和现实世界的证据，并利用我们团队的专业知识，我们正在不懈努力，以解决骨髓瘤患者未满足的需求，并推动开发新的治疗方案，以用于整个治疗模式，包括在第一线环境中。”。

TECVAYLI® studies investigate outpatient administration in patients with RRMM, examining a more convenient approach to treatment, including in a community setting

TECVAYLI®研究调查了RRMM患者的门诊管理，研究了一种更方便的治疗方法，包括在社区环境中

Extended follow-up of patients from a MajesTEC-1 cohort, investigating the prophylactic use of tocilizumab for the reduction of cytokine release syndrome (CRS) in patients treated with TECVAYLI®, were also presented at ASCO in an oral presentation (Abstract #7517).2 Results show a single dose of tocilizumab before TECVAYLI® in patients with RRMM (n=24) reduced the incidence of CRS with a 65 percent relative reduction versus the overall MajesTEC-1 population.2 This approach is continuing to be evaluated in the first-in-class Phase 2, multicenter, prospective OPTec study of TECVAYLI® in the community setting, presented as a poster presentation (Abstract #7528) at ASCO.3 Data showed preliminary evidence that prophylactic tocilizumab potentially reduces the incidence of CRS, with no new safety concerns to date and underscores the opportunity for outpatient administration.3 .

在ASCO的口头报告中，还对来自MajesTEC-1队列的患者进行了长期随访，研究了预防性使用托珠单抗减少接受TECVAYLI®治疗的患者的细胞因子释放综合征（CRS）。结果显示，在接受TECVAYLI®治疗的RRMM患者（n=24）之前，单剂量的托珠单抗可降低CRS的发生率，与总体MajesTEC-1人群相比，相对降低65%。2这种方法正在TECVAYLI的第一次2期多中心前瞻性OPTec研究中继续进行评估®在社区环境中，作为ASCO的海报展示（摘要#7528）。数据显示，初步证据表明，预防性托珠单抗可能降低CRS的发病率，迄今为止没有新的安全问题，并强调了门诊管理的机会。

Evaluation of patients with high-risk multiple myeloma from MajesTEC-1 study shows clinical benefit from treatment with TECVAYLI®

MajesTEC-1研究对高危多发性骨髓瘤患者的评估显示，使用TECVAYLI®治疗可获得临床益处

Subgroup analysis from the MajesTEC-1 study of TECVAYLI® investigating patients with HR RRMM will be presented at EHA (Abstract #923).4 Results show at a median follow-up of 30 months, patients who were aged 75 years or older, patients who had HR cytogenetics and patients who were penta-drug refractory demonstrated similar efficacy as the overall RP2D population with an ORR of 54 percent, 61 percent and 60 percent and a CR or better rate of 42 percent, 42 percent and 48 percent, respectively.4 The data demonstrate the clinical benefit of TECVAYLI® as an additional treatment option for some patients with HR features who typically face poor outcomes.4 The safety profile across subgroups was consistent with the RP2D population, including overall incidence and severity of TEAEs.4 .

TECVAYLI®研究HR RRMM患者的MajesTEC-1研究的亚组分析将在EHA（摘要#923）上进行。结果显示，在中位随访30个月时，75岁或以上的患者，HR细胞遗传学患者和五种药物难治性患者表现出与整个RP2D人群相似的疗效，ORR分别为54%，61%和60%，CR率或更高率分别为42%，42%和48%。4数据表明TECVAYLI®作为一些HR特征患者的额外治疗选择的临床益处，这些患者通常面临不良结局。4安全性亚组间的概况与RP2D人群一致，包括TEAE的总体发生率和严重程度。

Data from a single-arm run-in cohort of the Phase 3 MajesTEC-7 study shows early clinical profile of TECVAYLI®-based regimen in patients with transplant ineligible/not intended newly diagnosed multiple myeloma

来自MajesTEC-7研究3期单臂磨合队列的数据显示，基于TECVAYLI®的方案在移植不合格/非预期新诊断多发性骨髓瘤患者中的早期临床表现

The results, presented in an oral presentation (Abstract #7506) at ASCO, of the first safety run-in (SRI) from a single-arm cohort of the Phase 3 MajesTEC-7 study provide preliminary data for a TECVAYLI®-based regimen in transplant- ineligible/not intended newly diagnosed multiple myeloma.5 Patients (n=26) received TECVAYLI® in combination with daratumumab and lenalidomide (DR).5 At a median follow-up of 13.8 months, the ORR was 92 percent, with 23 patients remaining on treatment.5 Treatment-emergent adverse events (TEAEs) occurred in 100 percent of patients, where 61.5 percent of patients experienced grade 1/2 CRS in cycle one - all of which resolved.5 .

在ASCO的口头报告（摘要#7506）中介绍了来自MajesTEC-7研究第三阶段单臂队列的第一次安全磨合（SRI）的结果，为基于TECVAYLI®的移植方案提供了初步数据-不合格/无意新诊断的多发性骨髓瘤。5名患者（n=26）接受TECVAYLI®联合达拉木单抗和来那度胺（DR）。5中位随访13.8个月，ORR为92%，23名患者仍在接受治疗。5 100%的患者发生了治疗紧急不良事件（TEAE），其中61.5%的患者在第一周期经历了1/2级CRS-所有这些都得到了解决。

About the MajesTEC-1 Study

关于MajesTEC-1研究

MajesTEC-1 (NCT03145181, NCT04557098) is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study evaluating the safety and efficacy of teclistamab in adults with RRMM who received three or more prior lines of therapy.6,7

MajesTEC-1（NCT03145181，NCT04557098）是一项1/2期单臂，开放标签，多中心，多中心剂量递增研究，评估teclistamab在接受三种或三种以上先前治疗方案的RRMM成人中的安全性和有效性。6,7

Phase 1 of the study (NCT03145181) was conducted in two parts: dose escalation (Part 1) and dose expansion (Part 2).6 It evaluated safety, tolerability, pharmacokinetics, and preliminary efficacy of teclistamab in adult participants with RRMM.6 Phase 2 of the study (NCT04557098) evaluated the efficacy of teclistamab at the RP2D, established at subcutaneous 1.5 mg/kg weekly, as measured by ORR..

该研究的第一阶段（NCT03145181）分为两部分进行：剂量递增（第1部分）和剂量扩展（第2部分）[6]。它评估了替克利单抗在RRMM成年参与者中的安全性，耐受性，药代动力学和初步疗效。研究的第二阶段（NCT04557098）评估了替克利单抗在RP2D的疗效，该RP2D每周皮下注射1.5 mg/kg，由ORR测量。。

About the OPTec Study

关于OPTec研究

OPTec (NCT05972135) is a Phase 2, single-arm, non-randomized, multicenter, prospective study evaluating the use of prophylactic tocilizumab in patients with RRMM to reduce the incidence and severity of CRS associated with administration of the step-up dosing regimen of teclistamab in the outpatient setting..

OPTec（NCT05972135）是一项2期，单臂，非随机，多中心，前瞻性研究，评估预防性托珠单抗在RRMM患者中的应用，以降低与门诊使用替克利单抗递增给药方案相关的CRS的发生率和严重程度。。

About the MajesTEC-7 Study

关于MajesTEC-7研究

MajesTEC-7 (NCT05552222), is a Phase 3 randomized study, comparing teclistamab in combination with daratumumab SC and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab SC and lenalidomide (Tal-DR) versus daratumumab SC, lenalidomide, and dexamethasone (DRd) in participants with newly diagnosed multiple myeloma who are either ineligible or not intended for autologous stem cell transplant as initial therapy.8.

MajesTEC-7（NCT05552222）是一项3期随机研究，比较了teclistamab联合daratumumab SC和来那度胺（Tec DR）以及talquetamab联合daratumumab SC和来那度胺（Tal DR）与daratumumab SC，来那度胺和地塞米松（DRd）在新诊断的多发性骨髓瘤患者中的应用，这些患者要么不合格，要么不打算作为自体干细胞移植的初始治疗。

About TECVAYLI®

关于TECWAYLI®

TECVAYLI® (teclistamab-cqyv) received approval from the U.S. FDA in October 2022 as an off-the-shelf (or ready-to-use) antibody that is administered as a subcutaneous treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.2 The European Commission (EC) granted TECVAYLI® conditional marketing authorization (CMA) in August 2022 as monotherapy for the treatment of adult patients with RRMM who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody, and have demonstrated disease progression since the last therapy.

TECVAYLI®（teclistamab cqyv）于2022年10月获得美国FDA的批准，作为一种现成（或即用）抗体，用于皮下治疗复发或难治性多发性骨髓瘤（RRMM）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。2欧盟委员会（EC）于2022年8月授予TECVAYLI®条件性上市许可（CMA）作为单一疗法，用于治疗至少接受过三种治疗的RRMM成年患者，包括蛋白酶体抑制剂，一种免疫调节剂药物和抗CD38抗体，自上次治疗以来已证明疾病进展。

In August 2023, the EC granted the approval of a Type II variation application for TECVAYLI®, providing the option for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months. TECVAYLI® is a first-in-class, bispecific T-cell engager antibody therapy that uses innovative science to activate the immune system by binding to the CD3 receptor expressed on the surface of T-cells and to the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.

2023年8月，欧盟委员会批准了TECVAYLI®的II型变异申请，为达到完全缓解（CR）或更好至少六个月的患者提供了每两周减少1.5 mg/kg给药频率的选择。TECVAYLI®是一种一流的双特异性T细胞参与者抗体疗法，它使用创新科学通过与T细胞表面表达的CD3受体和B细胞成熟抗原（BCMA）结合来激活免疫系统。在多发性骨髓瘤细胞和一些健康的B系细胞表面表达。

In February 2024, the U.S. FDA approved the supplemental Biologics License Application (sBLA) for TECVAYLI® for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma who have achieved and maintained a CR or better for a minimum of six months..

2024年2月，美国FDA批准了TECVAYLI®的补充生物制剂许可证申请（sBLA），对于复发或难治性多发性骨髓瘤患者，每两周（Q2W）减少1.5 mg/kg的给药频率，这些患者已达到并维持CR或更好至少六个月。。

For more information, visit www.TECVAYLI.com.

欲了解更多信息，请访问www.TECWAYLI.com。

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.9 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.10 Multiple myeloma is the third most common blood cancer worldwide and remains an incurable disease.11 In 2024, it was estimated that more than 35,000 people will be diagnosed with multiple myeloma in the U.S.

多发性骨髓瘤是一种不可治愈的血癌，会影响一种称为浆细胞的白细胞，这种白细胞存在于骨髓中。9在多发性骨髓瘤中，这些浆细胞迅速增殖和扩散，并用肿瘤替代骨髓中的正常细胞。10多发性骨髓瘤是全球第三大常见血癌，仍然是一种不可治愈的疾病。11 2024年，据估计，美国将有超过35000人被诊断出患有多发性骨髓瘤。

and more than 12,000 people would die from the disease.12 People living with multiple myeloma have a 5-year survival rate of 59.8 percent.13 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.14,15 .

多发性骨髓瘤患者的5年生存率为59.8%.13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[14,15]。

TECVAYLI® IMPORTANT SAFETY INFORMATION

TECVAYLI®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 receivingTECVAYLI®. Initiate treatment with TECVAYLI® step-up dosing schedule to reduce risk of CRS.

警告：接受Tecvayli®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。开始使用TECVAYLI®递增剂量计划进行治疗，以降低CRS的风险。

Withhold TECVAYLI® until CRS resolves or permanently discontinue based on severity. Neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) and serious and life-threatening reactions, can occur in patients receiving TECVAYLI®. Monitor patients for signs or symptoms of neurologictoxicity, including ICANS, during treatment.

扣留TECVAYLI®直到CRS解决或根据严重程度永久停止。接受TECVAYLI®治疗的患者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的反应。在治疗期间监测患者的神经系统毒性体征或症状，包括ICAN。

Withhold TECVAYLI® until neurologic toxicity resolves or permanentlydiscontinue based on severity. TECVAYLI® is available only through a restricted program called the TECVAYLI® and TALVEY™ Risk Evaluation andMitigation Strategy (REMS). .

扣留TECVAYLI®直到神经毒性消退或根据严重程度永久停止。TECVAYLI®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。

INDICATION AND USAGE

适应症和用法

TECVAYLI® (teclistamab-cqyv) is a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager 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..

TECVAYLI®（teclistamab cqyv）是一种双特异性B细胞成熟抗原（BCMA）定向的CD3 T细胞接受者，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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

该适应症根据响应率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。

WARNINGS AND PRECAUTIONS

警告和注意事项

Cytokine Release Syndrome - TECVAYLI® can cause cytokine release syndrome (CRS), including life-threatening or fatal reactions. In the clinical trial, CRS occurred in 72% of patients who received TECVAYLI® at the recommended dose, with Grade 1 CRS occurring in 50% of patients, Grade 2 in 21%, and Grade 3 in 0.6%.

细胞因子释放综合征-TECVAYLI®可引起细胞因子释放综合征（CRS），包括危及生命或致命的反应。在临床试验中，72%接受推荐剂量TECVAYLI®的患者发生CRS，50%的患者发生1级CRS，21%的患者发生2级CRS，0.6%的患者发生3级CRS。

Recurrent CRS occurred in 33% of patients. Most patients experienced CRS following step-up dose 1 (42%), step-up dose 2 (35%), or the initial treatment dose (24%). Less than 3% of patients developed first occurrence of CRS following subsequent doses of TECVAYLI®. The median time to onset of CRS was 2 (range: 1 to 6) days after the most recent dose with a median duration of 2 (range: 1 to 9) days.

33%的患者发生复发性CRS。大多数患者在递增剂量1（42%），递增剂量2（35%）或初始治疗剂量（24%）后经历CRS。在随后剂量的TECVAYLI®后，不到3%的患者首次发生CRS。CRS发作的中位时间为最近一次剂量后2（范围：1至6）天，中位持续时间为2（范围：1至9）天。

Clinical signs and symptoms of CRS included, but were not limited to, fever, hypoxia, chills, hypotension, sinus tachycardia, headache, and elevated liver enzymes (aspartate aminotransferase and alanine aminotransferase elevation)..

CRS的临床体征和症状包括但不限于发烧，缺氧，寒战，低血压，窦性心动过速，头痛和肝酶升高（天冬氨酸转氨酶和丙氨酸转氨酶升高）。。

Initiate therapy according to TECVAYLI® step-up dosing schedule to reduce risk of CRS. Administer pretreatment medications to reduce risk of CRS and monitor patients following administration of TECVAYLI® accordingly. At the first sign of CRS, immediately evaluate patient for hospitalization. Administer supportive care based on severity and consider further management per current practice guidelines.

根据TECVAYLI®加速给药时间表开始治疗，以降低CRS的风险。服用预处理药物以降低CRS的风险，并相应地监测服用TECVAYLI®后的患者。在CRS的第一个迹象时，立即评估患者的住院情况。根据严重程度管理支持性护理，并根据当前的实践指南考虑进一步管理。

Withhold or permanently discontinue TECVAYLI® based on severity..

根据严重程度扣留或永久停用TECVAYLI®。。

TECVAYLI® is available only through a restricted program under a REMS.

TECVAYLI®只能通过REMS下的受限程序获得。

Neurologic Toxicity including ICANS - TECVAYLI® can cause serious or life-threatening neurologic toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS).

包括ICANS在内的神经系统毒性-TECVAYLI®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）。

In the clinical trial, neurologic toxicity occurred in 57% of patients who received TECVAYLI® at the recommended dose, with Grade 3 or 4 neurologic toxicity occurring in 2.4% of patients. The most frequent neurologic toxicities were headache (25%), motor dysfunction (16%), sensory neuropathy (15%), and encephalopathy (13%).

在临床试验中，57%接受推荐剂量TECVAYLI®治疗的患者发生神经系统毒性，2.4%的患者发生3级或4级神经系统毒性。最常见的神经系统毒性是头痛（25%），运动功能障碍（16%），感觉神经病（15%）和脑病（13%）。

With longer follow-up, Grade 4 seizure and fatal Guillain-Barré syndrome (one patient each) occurred in patients who received TECVAYLI®..

随着随访时间的延长，接受TECVAYLI®治疗的患者发生了4级癫痫发作和致命的格林-巴利综合征（各一名患者）。。

In the clinical trial, ICANS was reported in 6% of patients who received TECVAYLI® at the recommended dose. Recurrent ICANS occurred in 1.8% of patients. Most patients experienced ICANS following step-up dose 1 (1.2%), step-up dose 2 (0.6%), or the initial treatment dose (1.8%). Less than 3% of patients developed first occurrence of ICANS following subsequent doses of TECVAYLI®.

在临床试验中，6%接受推荐剂量TECVAYLI®的患者报告了ICAN。复发性ICAN发生在1.8%的患者中。大多数患者在递增剂量1（1.2%），递增剂量2（0.6%）或初始治疗剂量（1.8%）后经历了ICAN。随后服用TECVAYLI®后，不到3%的患者首次出现ICAN。

The median time to onset of ICANS was 4 (range: 2 to 8) days after the most recent dose with a median duration of 3 (range: 1 to 20) days. The most frequent clinical manifestations of ICANS reported were confusional state and dysgraphia. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS..

ICANS发病的中位时间为最近一次剂量后4（范围：2至8）天，中位持续时间为3（范围：1至20）天。据报道，ICAN最常见的临床表现是混乱状态和书写困难。在CRS解决后或在没有CRS的情况下，ICAN的发作可以与CRS同时发生。。

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

在治疗期间监测患者的神经毒性体征和症状。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治疗。根据建议的严重程度，扣留或永久停用TECVAYLI®，并考虑根据现行实践指南进行进一步管理。。

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

由于潜在的神经毒性，患者有意识水平低下的风险。建议患者在完成TECVAYLI®加速给药计划后48小时内以及在新出现任何神经毒性症状的情况下，避免驾驶或操作重型或潜在危险的机器，直到神经毒性消退。。

TECVAYLI® is available only through a restricted program under a REMS.

TECVAYLI®只能通过REMS下的受限程序获得。

TECVAYLI® and TALVEY™ REMS - TECVAYLI® 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-由于CRS和神经系统毒性（包括ICAN）的风险，TECVAYLI®只能通过称为TECVAYLI®和TALVEY™REMS的REMS下的受限程序获得。

Hepatotoxicity - TECVAYLI® can cause hepatotoxicity, including fatalities. In patients who received TECVAYLI® at the recommended dose in the clinical trial, there was one fatal case of hepatic failure. Elevated aspartate aminotransferase (AST) occurred in 34% of patients, with Grade 3 or 4 elevations in 1.2%.

肝毒性-TECVAYLI®可引起肝毒性，包括死亡。在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，有一例致命的肝衰竭病例。34%的患者发生天冬氨酸转氨酶（AST）升高，3级或4级升高1.2%。

Elevated alanine aminotransferase (ALT) occurred in 28% of patients, with Grade 3 or 4 elevations in 1.8%. Elevated total bilirubin occurred in 6% of patients with Grade 3 or 4 elevations in 0.6%. Liver enzyme elevation can occur with or without concurrent CRS..

28%的患者发生丙氨酸氨基转移酶（ALT）升高，3级或4级升高1.8%。总胆红素升高发生率为6%，3级或4级升高发生率为0.6%。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 TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity.

根据临床指示，在基线和治疗期间监测肝酶和胆红素。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。

Infections - TECVAYLI® can cause severe, life-threatening, or fatal infections. In patients who received TECVAYLI® at the recommended dose in the clinical trial, serious infections, including opportunistic infections, occurred in 30% of patients, with Grade 3 or 4 infections in 35%, and fatal infections in 4.2%.

感染-TECVAYLI®可导致严重、危及生命或致命的感染。在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，30%的患者发生严重感染，包括机会性感染，3级或4级感染占35%，致命感染占4.2%。

Monitor patients for signs and symptoms of infection prior to and during treatment with TECVAYLI® and treat appropriately. Administer prophylactic antimicrobials according to guidelines. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity..

在使用TECVAYLI®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。根据指南服用预防性抗菌药物。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。。

Monitor immunoglobulin levels during treatment with TECVAYLI® and treat according to guidelines, including infection precautions and antibiotic or antiviral prophylaxis.

在使用TECVAYLI®治疗期间监测免疫球蛋白水平，并根据指南进行治疗，包括感染预防措施和抗生素或抗病毒预防措施。

Neutropenia - TECVAYLI® can cause neutropenia and febrile neutropenia. In patients who received TECVAYLI® at the recommended dose in the clinical trial, decreased neutrophils occurred in 84% of patients, with Grade 3 or 4 decreased neutrophils in 56%. Febrile neutropenia occurred in 3% of patients.

中性粒细胞减少症-TECVAYLI®可导致中性粒细胞减少症和发热性中性粒细胞减少症。在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，84%的患者中性粒细胞减少，3级或4级中性粒细胞减少56%。3%的患者发生发热性中性粒细胞减少症。

Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local institutional guidelines. Monitor patients with neutropenia for signs of infection. Withhold TECVAYLI® based on severity.

在基线和治疗期间定期监测全血细胞计数，并根据当地机构指南提供支持性护理。监测中性粒细胞减少症患者的感染迹象。根据严重程度扣留TECVAYLI®。

Hypersensitivity and Other Administration Reactions - TECVAYLI® can cause both systemic administration-related and local injection-site reactions. Systemic Reactions - In patients who received TECVAYLI® at the recommended dose in the clinical trial, 1.2% of patients experienced systemic-administration reactions, which included Grade 1 recurrent pyrexia and Grade 1 swollen tongue.

超敏反应和其他给药反应-TECVAYLI®可引起全身给药相关和局部注射部位反应。全身反应-在临床试验中以推荐剂量接受TECVAYLI®治疗的患者中，1.2%的患者出现全身给药反应，包括1级复发性发热和1级舌头肿胀。

Local Reactions - In patients who received TECVAYLI® at the recommended dose in the clinical trial, injection-site reactions occurred in 35% of patients, with Grade 1 injection-site reactions in 30% and Grade 2 in 4.8%. Withhold TECVAYLI® or consider permanent discontinuation of TECVAYLI® based on severity..

局部反应-在临床试验中以推荐剂量接受TECVAYLI®的患者中，35%的患者发生注射部位反应，1级注射部位反应为30%，2级为4.8%。扣留TECVAYLI®或根据严重程度考虑永久停用TECVAYLI®。。

Embryo-Fetal Toxicity - Based on its mechanism of action, TECVAYLI® 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 TECVAYLI® and for 5 months after the last dose..

胚胎-胎儿毒性-根据其作用机制，TECVAYLI®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TECVAYLI®治疗期间和最后一剂后5个月内使用有效的避孕措施。。

ADVERSE REACTIONS

不良反应

The most common adverse reactions (≥20%) were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common Grade 3 to 4 laboratory abnormalities (≥20%) were decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin, and decreased platelets..

最常见的不良反应（≥20%）是发热，CRS，肌肉骨骼疼痛，注射部位反应，疲劳，上呼吸道感染，恶心，头痛，肺炎和腹泻。最常见的3至4级实验室异常（≥20%）是淋巴细胞减少，中性粒细胞减少，白细胞减少，血红蛋白减少和血小板减少。。

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

请阅读TECVAYLI®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，我们在今天的全方位医疗解决方案中具有独特的创新地位，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..

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。。

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 TECVAYLI® (teclistamab-cqyv). 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》中关于TECVAYLI®（teclistamab cqyv）的产品开发、潜在利益和治疗影响的“前瞻性声明”。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 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的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。

C.

C。

* Niels van de Donk, M.D., Professor of Hematology at Amsterdam University Medical Centers, and principal study investigator has provided consulting, advisory, and speaking services to Johnson & Johnson; he has not been paid for any media work.

*阿姆斯特丹大学医学中心血液学教授、首席研究研究员Niels van de Donk医学博士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。

a Triple-class exposed (TCE): patients who have previously received an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody (mAb).  b Recommended Phase 2 dose (RP2D): dose of a drug that was identified in a Phase 1 study (dose finding study).

三类暴露（TCE）：先前接受过免疫调节剂（IMiD），蛋白酶体抑制剂（PI）和抗CD38单克隆抗体（mAb）的患者。b推荐的2期剂量（RP2D）：在1期研究（剂量发现研究）中确定的药物剂量。

1 Garfall, A., et al. Long-term follow-up from the phase 1/2 MajesTEC-1 trial of teclistamab in patients with relapsed/refractory multiple myeloma. 2024 ASCO Annual Meeting – American Society of Clinical Oncology. June 2024. 2 Van de Donk, N., et al. Longer-term follow-up of patients (pts) receiving prophylactic tocilizumab (toci) for the reduction of cytokine release syndrome (CRS) in the phase ½ MajesTEC-1 study of teclistamab in relapsed/refractory multiple myeloma (RRMM).

1 Garfall，A。等人。复发/难治性多发性骨髓瘤患者teclistamab 1/2期MajesTEC-1试验的长期随访。2024年ASCO年会-美国临床肿瘤学会。2024年6月。2 Van de Donk，N。等人。在teclistamab治疗复发/难治性多发性骨髓瘤（RRMM）的½期MajesTEC-1研究中，接受预防性tocilizumab（toci）以减少细胞因子释放综合征（CRS）的患者（pts）的长期随访。

2024 ASCO Annual Meeting – American Society of Clinical Oncology. June 2024.  3 Rifkin, R., et al. OPTec: A phase 2 study to evaluate outpatient (OP) step-up administration of teclistamab (Tec), a BCMA-targeting bispecific antibody, in patients (pts) with relapsed/refractory multiple myeloma (RRMM).4 Costa, L., et al.

2024年ASCO年会-美国临床肿瘤学会。2024年6月。3 Rifkin，R。等人。OPTec：一项2期研究，用于评估复发/难治性多发性骨髓瘤（RRMM）患者（pts）门诊（OP）逐步服用teclistamab（Tec）（一种靶向BCMA的双特异性抗体）。4 Costa，L。等人。

Efficacy and safety of teclistamab in patients with relapsed/refractory multiple myeloma with high-risk features: A subgroup analysis from the phase 1/2 MajesTEC-1 study. 2024 EHA Hybrid Congress – European Hematology Association. June 20245 Touzeau, C., et al. Safety results from the phase 3 MajesTEC-7 study in patients (pts) with transplant ineligible/not intended newly diagnosed multiple myeloma (NDMM).

teclistamab治疗具有高危特征的复发/难治性多发性骨髓瘤患者的疗效和安全性：1/2期MajesTEC-1研究的亚组分析。2024年EHA混合大会-欧洲血液学协会。2014年6月25日Touzeau，C。等人。MajesTEC-7期研究对移植不合格/非预期新诊断多发性骨髓瘤（NDMM）患者的安全性结果。

2024 ASCO Annual Meeting – American Society of Clinical Oncology. June 2024.6 A Study of Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1). https://clinicaltrials.gov/ct2/show/NCT04557098. Accessed June 2024.7 Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma (MajesTEC-1). https://clinicaltrials.gov/ct2/show/NCT03145181.

2024年ASCO年会-美国临床肿瘤学会。2024年6月6日对复发或难治性多发性骨髓瘤（MajesTEC-1）参与者进行的Teclistamab研究。https://clinicaltrials.gov/ct2/show/NCT04557098.2024年6月访问。7 Teclistamab（一种人源化BCMA*CD3双特异性抗体）在复发或难治性多发性骨髓瘤（MajesTEC-1）参与者中的剂量递增研究。（笑声）https://clinicaltrials.gov/ct2/show/NCT03145181.

Accessed June 2024.8 A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With D.

2024年6月访问.8 Teclistamab联合达拉木单抗和来那度胺（Tec DR）以及Talquetamab联合D的研究。

Media contact: Christie Corbett 1-857-636-0211   Satu Glawe+49 172-294-6264

媒体联系人：Christie Corbett 1-857-636-0211 Satu Glawe+49 172-294-6264

Investor contact: Raychel Kruperinvestor-relations@its.jnj.com   U.S. medical inquiries:+1 800 526-7736

投资者联系人：RaychelKruperinvestor-relations@its.jnj.com美国医疗查询：+1 800 526-7736

SOURCE Johnson & Johnson

来源强生公司