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RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is Merck’s investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Global recruitment of the waveLINE-010 trial has begun, with patients now enrolling. “ Following the encouraging results observed in the Phase 2 waveLINE-007 trial, we look forward to evaluating the potential clinical benefits of a combination regimen with zilovertamab vedotin in patients with diffuse large B-cell lymphoma compared to the current standard treatment,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “ ADCs have shown promise as an important modality in the treatment of different cancer types, and the initiation of this Phase 3 waveLINE clinical trial demonstrates our commitment to researching zilovertamab vedotin to help address unmet needs for patients with this aggressive and most common form of non-Hodgkin lymphoma.” WaveLINE-010 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT06717347 ), which is enrolling an estimated 1,046 patients globally. The primary endpoint is progression-free survival (PFS), and secondary endpoints include complete response (CR) rate at the end of the treatment, overall survival, event-free survival, duration of CR and safety. Zilovertamab vedotin is currently being evaluated in the Phase 2/3 waveLINE-003 dose confirmation and expansion trial ( NCT05139017 ) for the treatment of relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial ( NCT05406401 ) in combination with R-CHP in patients with previously untreated DLBCL. Merck recently presented data from this trial for the first time at the 66 th American Society of Hematology Annual Meeting and Exposition in December 2024. About diffuse large B-cell lymphoma Lymphoma is cancer beginning in the lymphatic system – the network of organs, vessels and tissues that protects the body from infection. There are many subtypes of lymphoma, which is often categorized into two main types – Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Diffuse large B-cell lymphoma, the most common form of NHL, is derived from white blood cells that grow rapidly and uncontrollably, enlarging the lymph nodes and often migrating to other parts of the body. DLBCL accounts for approximately 25-30% of all NHLs worldwide. In the U.S., it is estimated that approximately 25,000 patients are diagnosed with DLBCL each year. The five-year relative survival rate for DLBCL is 60-70%. About zilovertamab vedotin (MK-2140) Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and is establishing a robust program of clinical trials under the name waveLINE. The waveLINE program includes a Phase 2/3 study in patients with relapsed or refractory DLBCL (waveLINE-003, NCT05139017 ) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401 ). About Merck in hematology Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic disorders. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www-merck-com.libproxy1.nus.edu.sg/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

点击蓝字 关注我们 编者按 2025年1月17日至19日，中国临床肿瘤学会（CSCO）白血病、淋巴瘤及骨髓瘤专家委员会工作会议暨2025年CSCO血液肿瘤学术大会在海口召开。会议现场，《肿瘤瞭望-血液时讯》特邀上海交通大学医学院附属瑞金医院许彭鹏教授，就外周T细胞淋巴瘤的发病机制、精准治疗策略以及未来研究方向进行了深入的分享与探讨。 01 《肿瘤瞭望-血液时讯》 外周T细胞淋巴瘤在血液系统恶性肿瘤中具有独特的发病特点，其发病率相对较低但侵袭性较强，严重影响患者的生活质量与预后。您能否详细阐述一下目前研究发现的主要发病机制，以及这些机制对我们理解该疾病的发展进程有何重要意义呢？ 许彭鹏教授：实际上，外周T细胞淋巴瘤（PTCL）的发病机制颇为错综复杂，涵盖了表观遗传学以及免疫微环境等变化，这些因素协同作用，共同塑造了PTCL的高度异质性特征。从病理学的角度细分，PTCL可被进一步划分为众多具有独特性的亚型。尤为重要的是，各病理亚型的患者往往伴随着各不相同的信号通路异常及发病机制的特异性变化。 鉴于此，针对外周T细胞淋巴瘤患者的治疗策略，未来极有可能会依据其个体化的发病机制进行精准定制。这标志着治疗方式的重大转变，不再局限于当前普遍采用的如CHOP（环磷酰胺、阿霉素、长春新碱、泼尼松）等标准化治疗方案。随着我们对PTCL发病机制认知的不断深化，治疗方案势必会逐步得到革新与优化，以期为患者提供更加精准有效的治疗途径。 02 《肿瘤瞭望-血液时讯》 外周T细胞淋巴瘤由于其异质性，在诊断和治疗方面都面临诸多挑战。您在讲座中着重探讨了靶向治疗探索，在当下靶向治疗药物不断涌现的背景下，针对外周 T 细胞淋巴瘤，目前有哪些具有潜力的靶向治疗靶点被发现，它们为治疗该疾病带来了哪些新的希望和突破？ 许彭鹏教授：此前，我们团队开展了一项开放标签、多中心、Ⅱ期GUIDANCE-03研究，旨在评估靶向药物联合经典CHOP方案作为外周T细胞淋巴瘤初诊患者一线治疗方案的疗效及安全性概况。鉴于不同基因突变患者体内信号传导通路及免疫微环境各异，该研究依据患者特有的基因突变情况（TP53、TET2、CREBBP/EP300及KMT2D等），个性化地引入了不同靶向药物进行联合治疗。 在深入探索针对不同亚型患者的联合治疗方案时，我们初步见证了CHOP-X方案在疗效方面的显著提升。相较于传统的CHOP治疗方案，CHOP-X策略为患者提供了无进展生存期（PFS）上的额外优势，这一积极趋势预示着有可能转化为总生存期（OS）的延长，从而为患者预后带来积极影响。 展望未来，随着我们对PTCL这一复杂疾病理解的日益深化，期待能够持续优化针对不同分子亚型的靶向治疗方案。有理由相信，通过实施这些精细化的治疗策略，将有望进一步提升高危、难治性PTCL患者的治疗效果，为患者群体带来更为显著且持久的生存获益。 03 《肿瘤瞭望-血液时讯》 您在讲座中强调了深入研究外周 T 细胞淋巴瘤发病机制对于精准治疗的重要性。鉴于目前临床实践中，传统治疗方法对外周 T 细胞淋巴瘤的疗效存在一定局限性，那么基于对发病机制的了解，我们在靶向治疗药物的研发和应用方向上，未来应如何更好地优化和创新，以提高患者的生存率和生活质量？ 许彭鹏教授：在针对某一疾病的药物研发过程中，首要且关键的步骤在于对其发病机制的深刻理解和透彻洞察。唯有当我们对疾病的本质有了更为全面和深入的认识，才有望研发出更加精准的治疗药物。近年来，外周T细胞淋巴瘤的靶向药物研发领域取得了令人瞩目的显著进展。这些进步不仅体现在对传统药物的改良和优化上，更体现在一系列新型药物的涌现上，如表观遗传学药物、JAK抑制剂等。这些创新药物已逐步融入临床实践，并取得了令人欣慰的良好疗效。 展望未来，随着细胞免疫治疗技术，特别是CAR-T治疗等领域的不断成熟和完善，以及我们对PTCL靶点认知的持续深化，有理由相信这些新兴的治疗方式将为患者带来更多治疗希望。它们不仅可能超越传统治疗手段，实现更为优越的治疗效果，还可能为PTCL患者开辟全新的治疗路径，从而显著改善患者的预后，为他们的生活质量带来实质性的提升。 （来源：《肿瘤瞭望–血液时讯》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。