Lazertinib Mesylate

IDC2026圆满落幕，会后报告详情请点击图片👆IDC2027论坛合作请联系：李欣欣 177 0186 0390 一条从未在一线EGFR肺癌出现过的PFS曲线，浮出水面。 2026 ESMO摘要数据陆续公布，市场目光都被LBA和全球三期数据吸引，一个惊艳的二期数据细节被忽略。 百利天恒公布了iza-bren（EGFR×HER3双抗ADC）联合奥希替尼针对一线EGFRm NSCLC的中国二期随访更新：中位随访22.8个月（较去年WCLC 2025延长约10个月），ORR 100%、18个月PFS率92.2%。 40例患者，去年12个月PFS率92.1%，一年过后，零患者脱落，PFS曲线继续走平。 这在EGFR-TKI用药历史上十分罕见，TKI时代的PFS曲线从来都是平滑下行的，耐药克隆以近似恒定速率出逃，无论是奥希替尼单药还是奥希替尼+化疗，曲线形状不变，区别只是中位数的长短。而iza-bren+奥希替尼走出了一条只在免疫治疗中才有的“拖尾效应”曲线，这可能是一线EGFR NSCLC的第一条。 通过这个数据，完美或许能理解为什么BMS敢于启动IZABRIGHT-Lung02，一个头对头挑战当前全球最强一线方案“奥希替尼+化疗”的全球三期研究。 01 曲线走平，含金量多高？ ORR 100%看起来很厉害，在PFS率指标含金量下显得没那么重要。 ORR在一线EGFR是最不值钱的终点：奥希替尼单药80%、FLAURA2（奥希替尼+化疗）83%、MARIPOSA（埃万妥单抗+兰泽替尼）86%。一线EGFR几乎人人缩瘤，真正的分水岭在于持久性。 所以真正的核心信息在于：12个月PFS率92.1% → 18个月PFS率92.2%。 n=40的队列里，92%对应的是累计仅约3个PFS事件。中位随访从12.5个月拉到22.8个月（+10.3个月），事件数不变，意味着约37名患者全部无进展跨过了18个月线。那个0.1个百分点的“上升”只是KM删失再分配的统计伪影，这意味着：12到18个月窗口内，零新增患者进展事件。 在竞品坐标中，更能看清数据的含金量：奥希替尼单药的中位PFS 18.9个月，意味着18个月点恰好在50%出头；FLAURA2联合组从12个月约80%掉到24个月约57%；MARIPOSA从12个月73%掉到24个月48%。 所有TKI方案在12到18个月窗口都有明显的曲线下行。iza-bren+奥希替尼在同一窗口零下行，数值上领先FLAURA2联合组超过30个百分点（跨试验、单臂n=40 vs 随机三期，仅供量级参照）。 那么问题来了，凭什么iza-bren+奥希替尼能走出这种“免疫治疗才有的曲线形态”？ TKI时代PFS曲线没有出现过平台效应，因为TKI本质上是按激酶构象抑制的，耐药克隆只要完成激酶域突变或旁路信号激活，就能逃逸。曲线从不停歇地下行，形状始终是恒定风险型。 iza-bren的杀伤逻辑则完全不同，作为EGFR×HER3双抗ADC，它的杀伤靠抗原表达内吞递送载荷（拓扑异构酶I抑制剂Ed-04，DAR 8），与EGFR激酶域状态无关。C797S耐药突变克隆、MET扩增旁路克隆，只要细胞表面仍表达EGFR或HER3，就在ADC的火力覆盖范围内。 更有意思的是一个“越耐药越显著”的自适应逻辑：TKI耐药后HER3常代偿性上调（HER3在EGFRm NSCLC表达率约七至八成），肿瘤的耐药演化方向恰好走进了ADC的靶向区域。加上双抗原结合和旁观者杀伤效应（Ed-04的膜渗透性载荷可杀伤邻近的双阴性细胞），对肿瘤异质性的覆盖度远超单靶ADC。 再叠加一线部署的数学优势：一线时肿瘤负荷最低、克隆多样性最小、血管结构完整（ADC递送效率高），100%缩瘤、中位缩瘤56.7%的深缓解把残余病灶压到最小，克隆重启进展的时间被拉长。随访窗口内的表现就是曲线走平。 当然，偏差或者争议点也要摆出来：n=40、单臂、中国临床，12个月时间点的95%置信区间下沿是77.5%（18个月点预计更宽），这个曲线“走平”到底是分子属性还是小样本的运气，需要后续验证。 02 要撼动1L EGFR肺癌格局，得打败谁？ iza-bren+奥希替尼如果要在全球重新定义一线EGFR的治疗格局，必须在PFS上打败现有最强方案。 目前一线EGFR已有数据最强的几个研究摆在一起： ● FLAURA2（奥希替尼+培美/铂类化疗），BICR评估mPFS 29.4个月、中位OS 47.5个月（HR 0.77），是全球三期最长PFS+OS双料纪录保持者； ● AENEAS2（阿美替尼+化疗，中国624例），BICR评估mPFS 28.9个月（HR 0.47），与FLAURA2几乎并驾； ● MARIPOSA（埃万妥单抗+兰泽替尼），研究者评估mPFS 23.7个月（HR 0.70），OS HR 0.75但中位未达vs 36.7个月。 ● 奥希替尼单药作为老基准，mPFS 18.9个月。 百利天恒和BMS分别布局了两条线：PANKU-Lung04（中国三期，n=720，2025年2月启动），对照臂是奥希替尼单药，这是中国注册路径，是更容易的一条线；IZABRIGHT-Lung02（全球三期，n=850，BMS主导，2026年9月8日启动），对照臂直接对着奥希替尼单药和/或奥希替尼+化疗亮剑，这是竞争全球标准，这是最难的一条线，先易后难的策略很清晰。 聚焦到全球研究IZABRIGHT-Lung02的设计，难度一目了然。 这是一个三臂、随机、开放标签的全球三期，覆盖201个中心、16个国家（中国43个中心为最大集群），iza-bren+奥希替尼 vs 奥希替尼单药 vs 奥希替尼+铂类化疗，主要终点PFS（BICR），预计约3年读出，OS约5年。入组要求非鳞、IIIB-IVB期或复发、Ex19del/L858R、颅外可测量病灶、ECOG 0-1。 这个试验可以说是一场豪赌，因为对照臂的历史先验极高。FLAURA2 BICR口径29.4个月已经是全球一线EGFR的天花板，而IZABRIGHT-Lung02的中国中心占比最大（亚裔富集）+ 排除不稳定CNS转移 + 要求颅外可测量病灶，这三个因素结构性推高对照臂的PFS，对照臂大概率站在29个月往上。 如果要达到HR 0.70-0.75的可检测效应量（三期通常需要的水平），预计治疗臂的中位PFS至少需要达到39-42个月。 39-42个月的中位PFS在EGFR一线是从未有人达到过的数字，FLAURA2用了奥希替尼+化疗才做到29.4个月，iza-bren+奥希替尼要在这个基础上再拉出10-13个月的绝对差距，难度不言而喻。 不过反过来看，BMS在2026年9月触发了2.5亿美元里程碑付款启动这项研究，BMS当然清楚阳性标准有多高，它大概率就是看到了这条走平的PFS曲线，以及背后“如果走平持续，39-42个月大概率有戏”的推算逻辑。 不过，参照FLAURA2（557例，2020启动、2023读出），850例全球多臂+约3年随访+BICR，PFS读出大概率在2029-2031年，未来3-5年的一线叙事只能依靠二期随访更新托底。 03 24个月PFS率，下一个关键闸门 18个月PFS率走平已经打下了很好的基础，但市场需要盯的下一个数据是24个月PFS率。 这个数字为什么关键？因为它直接决定了中位PFS能落在什么位置。 18个月PFS率92.2%已经说明：即使后续曲线不再走平而是恢复下行，中位PFS做出来比较好的结果已经有个打底。 我们基于不同的衰减假设做情景推算（仅供参考）： 1）如果18个月后曲线继续走平（最乐观情景），24个月PFS率有望维持在88%以上，中位PFS将推到40个月以上，远超任何现有方案； 2）如果恢复到FLAURA2联合组在第二年的衰减速率，24个月PFS率大约落在78%附近，隐含中位PFS约40个月，仍然大幅领先现有最强标准； 3）如果恢复到奥希替尼单药第二年的衰减速率（更保守假设），24个月PFS率约73%，隐含中位PFS约33个月，依然站在FLAURA2之上； 4）如果出现断崖式再衰减，24个月PFS率跌破60%，“走平”叙事将被证伪，中位PFS大概率不到30个月； 基于以上推测，验证阈值大致可分为三层：24个月点PFS率≥80%，长尾坐实，全球验证吃下定心丸；65-80%之间，常态化但中位在30-40个月区间，获批路径仍然清晰；跌破65%-60%，叙事存疑/失败概率很大。 但未来研究局限性，同样不能回避。 颅内是最大的隐患。大分子ADC受血脑屏障限制，iza-bren缺乏CNS专项数据，而FLAURA2恰好有颅内PFS 30.2个月的强势优势，颅内失败有可能成为颅外评估曲线的隐藏门。 另外毒性累积是长期给药的考验，Q3W方案连续给药两三年的骨髓抑制累积无先例，停药率如果随时间恶化，曲线有可能重新下弯。 最终，耐药终会出现，抗原双丢失、TOP1i载荷耐药、外排泵上调，在T-DXd等ADC中已有获得性耐药先例，这些都需要长随访进行验证。 结语：如果iza-bren+奥希替尼的PFS曲线继续走平，或者下降幅度低到超出市场预期，那么IZABRIGHT-Lung02大概率可以撕掉豪赌的标签，BMS是真的要奔着掀翻一线EGFR全球最强方案去的，届时iza-bren的价值天花板将进一步提升，1L EGFR的SOC标准可能也将随之改写。 不过，至少得等到2029年以后才能揭晓了，在此之前，要盯紧24个月PFS率这个闸门。 END 免责声明：本文仅作知识交流与分享及科普目的，不涉及商业宣传，不作为相关医疗指导或用药建议。文章如有侵权请联系删除。 IDC2026圆满落幕，会后报告详情请点击图片👆IDC2027论坛合作请联系：李欣欣 177 0186 0390

Complete responses were seen in 14% of patients with head and neck squamous cell carcinoma (HNSCC) other than human papillomavirus ( HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC); 65% of responses in this subgroup remained ongoing at clinical cutoff 1 These Phase 1b/2 study results support continued evaluation of the investigational amivantamab-based regimen in the ongoing first-line Phase 3 study Data highlight the role of dual-targeting EGFR and MET, key drivers of tumour growth and resistance seen in 80-90% of HNSCC 2 BEERSE, BELGIUM, Oct. 25, 2026 (GLOBE NEWSWIRE) -- Johnson & Johnson today announced new results from Cohort 5 of the Phase 1b/2 OrigAMI-4 study with first-line subcutaneous RYBREVANT ® ▼ (amivantamab) plus a PD-1 inhibitor and fixed-duration carboplatin chemotherapy in patients with advanced recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) other than human papillomavirus (HPV)-associated oropharyngeal squamous cell carcinoma (OPSCC). 1 These findings support the ongoing pivotal Phase 3 OrigAMI-5 study and further expand the clinical development programme for subcutaneous amivantamab for patients with head and neck cancer. Among patients with HNSCC other than HPV-associated OPSCC, results demonstrated a confirmed overall response rate (ORR) of 77%, including 14% achieving complete responses. 1 Tumour shrinkage was observed in all evaluable patients, and nearly two-thirds of responses remained ongoing at a median follow-up of 10.6 months. 1 These findings were presented as a rapid oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026 (Abstract #1539RO). Unmet need remains in first-line head and neck cancer treatment For people with recurrent or metastatic head and neck cancer, the first-line treatment decision after progression comes at a critical point in an aggressive disease often associated with poor prognosis. 3 While some patients benefit from the current standard of care, many experience disease progression while facing symptoms that can profoundly affect daily life, including the ability to eat, swallow and speak. 4 ,5 Nearly 60% of patients do not go on to receive subsequent treatment, underscoring the need to help more patients achieve meaningful tumour reduction and durable responses from the start. 3 Expert and company perspectives on the role of amivantamab in advancing first-line treatment “Patients with recurrent or metastatic head and neck cancer continue to face a poor prognosis, highlighting the need for new treatment approaches,” said Kevin Harrington, M.D., Ph.D., Professor of Biological Cancer Therapies at The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust.* “The data presented from Cohort 5 of the OrigAMI-4 study are promising, with the triplet combination of amivantamab, a PD-1 inhibitor and chemotherapy demonstrating encouraging response rates, ongoing responses and early survival findings in patients with HPV-unassociated tumours in the recurrent or metastatic first-line setting. These findings offer an opportunity to explore how we might improve outcomes for patients with this challenging disease.” “We’ve already seen what subcutaneous amivantamab may offer patients with head and neck cancer after their disease has progressed. Now, we see the potential impact of using this approach earlier in recurrent or metastatic disease,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “Our experience with amivantamab in lung cancer has helped establish the potential of dual EGFR/MET targeting, and these results support continued evaluation of this approach in head and neck cancer.” "People living with recurrent or metastatic head and neck cancer need treatments that can deliver meaningful benefits from the very beginning of their treatment journey," said Henar Hevia, Ph.D., EMEA Therapeutic Area Head, Oncology, Johnson & Johnson. "These results reinforce our ambition to raise expectations of what might be possible for patients with this challenging disease and give us further confidence to advance subcutaneous amivantamab in the recurrent or metastatic first-line setting, as we continue to evaluate this approach in Phase 3." Amivantamab demonstrates meaningful anti-tumour activity in first-line disease Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab in combination with pembrolizumab (PD-1 inhibitor) and up to six cycles of carboplatin in previously untreated patients with recurrent or metastatic HNSCC. 1 Patients received treatment every three weeks following the initial treatment period, with an administration time of five minutes or less. 1 The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1).** 1 Response rates were assessed separately in patients with HPV-associated OPSCC (n=7) and patients with all other forms of HNSCC (n=22), given known differences in how these patient populations respond to EGFR-targeted bispecifics. 1 Thirty patients received subcutaneous amivantamab in combination with pembrolizumab and carboplatin, and 29 were included in the efficacy analysis. 1 One patient was deemed ineligible. 1 Among 22 patients with forms of HNSCC other than HPV-associated OPSCC, the confirmed ORR was 77% (95% confidence interval [CI], 55-92), including complete responses in 14% and partial responses in 64%. 1 Responses occurred at a median of 9.4 weeks, with 65% ongoing at a median follow-up of 10.6 months. 1 Four patients (18%) had stable disease and one (5%) had progressive disease. 1 Median overall survival was not reached and 77% of patients were alive at one year. 1 The remaining seven patients had HPV-associated OPSCC, with an ORR of 29% (95% CI, 4-71). 1 The safety pro subcutaneous amivantamab in combination with pembrolizumab and carboplatin was consistent with the individual agents. 1 The most common adverse events were anaemia (73%), hypoalbuminaemia (63%), thrombocytopenia (63%) and stomatitis (57%). 1 Administration-related reactions associated with subcutaneous amivantamab occurred in 13% of patients, with no Grade 3 or higher events reported. 1 The Cohort 5 findings build on earlier first-line results from the OrigAMI-4 programme, including Cohort 2 data evaluating subcutaneous amivantamab in combination with pembrolizumab recently published in Clinical Cancer Research . 6 About the OrigAMI-4 Study OrigAMI-4 is an open-label Phase 1b/2 study evaluating subcutaneous amivantamab in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC). 7 The study includes six cohorts, including Cohort 5, which studied subcutaneous amivantamab across different treatment settings and regimens. 1 Cohort 5 of the OrigAMI-4 study evaluated subcutaneous amivantamab, administered every three weeks, in combination with pembrolizumab and carboplatin in patients with R/M HNSCC receiving first-line treatment whose tumours tested positive for programmed death-ligand 1 (PD-L1), with a combined positive score (CPS) of one or greater. 1 The primary endpoint was ORR, as assessed by investigators using Response Evaluation Criteria in Solid Tumours version 1.1 (RECIST v1.1). 1 About Head and Neck Squamous Cell Carcinoma HNSCC is the most common form of head and neck cancer, a group of cancers that arise in the mouth, throat, voice box, sinuses, nasal cavity and salivary glands. 8 It represents approximately 4.5% of all cancers worldwide and is the seventh most common cancer globally. 8 Major risk factors include tobacco and alcohol use, as well as infection with high-risk HPV. 8 Around 75% of cases are HPV-unassociated, which is typically linked with a poorer prognosis and reduced response to treatment. 9,10 Despite advances in surgery, radiation, chemotherapy, and immunotherapy, many patients ultimately progress to advanced, recurrent or metastatic disease. 1 1 About Amivantamab Amivantamab is a fully-human EGFR-MET bispecific antibody that acts by targeting tumours with activating and resistance EGFR mutations and MET mutations and amplifications, and by harnessing the immune system. 1 2,13,14 The European Commission (EC) has approved amivantamab in the following indications (intravenous and subcutaneous): 15 In combination with lazertinib for the first-line treatment of adult patients with advanced non–small cell lung cancer (NSCLC) with EGFR exon 19 deletions or exon 21 L858R substitution mutations. In combination with carboplatin and pemetrexed for the treatment of adult patients with advanced NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations after failure of prior therapy, including an EGFR tyrosine kinase inhibitor (TKI). In combination with carboplatin and pemetrexed for the first-line treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations. As monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy. Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE ® drug delivery technology. 1 6 For a full list of undesirable effects and information on dosage and administration, contraindications and other precautions when using amivantamab, please refer to the Summary of Product Characteristics . 15 ▼ In line with EU regulations for new medicines, amivantamab is subject to additional monitoring. About Johnson & Johnson 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. Learn more at . Follow us at . Caution Concerning Forward-Looking Statements 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 amivantamab. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Johnson & Johnson. 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; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour 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. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s most recent Annual Report on Form 10-K, 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. Copies of these filings are available online at or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. *Kevin Harrington, M.D., Ph.D. has served as a consultant to Johnson & Johnson; he has not been paid for any media work. ** RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger. CP-608853 October 2026 ### References: 1 Swiecicki P, et al. Amivantamab + pembrolizumab + carboplatin in first-line recurrent/metastatic head & neck squamous cell cancer (1L R/M HNSCC) Results from the phase 1b/2 OrigAMI-4 study. Presented at: European Society for Medical Oncology (ESMO) 2026 Congress; October 25, 2026; Madrid. 2 Kalyankrishna S, Grandis JR. Epidermal growth factor receptor biology in head and neck cancer. J Clin Oncol . 2006;24(17):2666–2672. 3 Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): a randomised, open-label, phase 3 study. Lancet . 2019;394(10212):1915-1928. doi:10.1016/S0140-6736(19)32591-7. 4 Nissi L, et al. Recurrence of head and neck squamous cell carcinoma in relation to high-risk treatment volume. Clin Transl Radiat Oncol . 2021;27:139-146. doi:10.1016/j.ctro.2021.01.013. 5 Zebralla V, Wichmann G, Pirlich M, et al. Dysphagia, voice problems, and pain in head and neck cancer patients. Eur Arch Otorhinolaryngol. 2021;278(10):3985-3994. doi:10.1007/s00405-020-06584-6. 6 Kao H-F, et al. Amivantamab plus pembrolizumab in previously untreated recurrent/metastatic head and neck squamous cell cancer: Results from the phase 1b/2 OrigAMI-4 study. Clin Cancer Res. 2026 Sep 15. doi: 10.1158/1078-0432.CCR-26-1372. 7 ClinicalTrials.gov. A Study of Amivantamab Alone or in Addition to Other Treatment Agents in Participants With Recurrent/ Metastatic Head and Neck Cancer (OrigAMI-4). Available at: . Accessed October 2026. 8 Barsouk A, et al. Risk Factors, and Prevention of Head and Neck Squamous Cell Carcinoma. Medical Sciences. 2023; 11(2):42. 9 Hartmann, S, et al. HGF/Met Signaling in Head and Neck Cancer: Impact on the Tumor Microenvironment. Clin Cancer Res. 2016 Aug 15;22(16):4005-13. doi: 10.1158/1078-0432.CCR-16-0951. 1 0 Ghiani L, Chiocca S. High Risk-Human Papillomavirus in HNSCC: Present and Future Challenges for Epigenetic Therapies. International Journal of Molecular Sciences . 2022;23(7):3483. 11 Ferris RL, Blumenschein G Jr, Fayette J, et al. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. New England Journal of Medicine . 2016;375(19):1856-1867. 12 Moores SL, Chiu ML, Bushey BS, et al. A Novel Bispecific Antibody Targeting EGFR and cMet Is Effective against EGFR Inhibitor-Resistant Lung Tumors. Cancer Res . 2016;76(13):3942-3953. doi:10.1158/0008-5472.CAN-15-2833. 13 Yun J, Lee SH, Kim SY, et al. Antitumor Activity of Amivantamab (JNJ-61186372), an EGFR-MET Bispecific Antibody, in Diverse Models of EGFR Exon 20 Insertion-Driven NSCLC. Cancer Discov . 2020;10(8):1194-1209. doi:10.1158/2159-8290.CD-20-0116. 14 Grugan KD, et al. Fc-mediated activity of EGFR x c-Met bispecific antibody JNJ-61186372 enhanced killing of lung cancer cells. Mabs. 2017;9(1):114-126. 15 European Medicines Agency. Amivantamab Summary of Product Characteristics. Available at: . Accessed October 2026. 16 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO Journal of Clinical Oncology. 2024;42(3):3593-3605. CONTACT: Media contact: Pasquale Monteleone PMontele@ITS.JNJ.com Investor contact: JessMargevich investor-relations@its.jnj.com