{"id":809667,"date":"2025-02-06T06:49:34","date_gmt":"2025-02-06T11:49:34","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/merck-announces-phase-3-waveline-010-trial-initiation-evaluating-zilovertamab-vedotin-an-investigational-antibody-drug-conjugate-for-the-treatment-of-patients-with-previously-untreated-diffuse-large\/"},"modified":"2025-02-06T06:49:34","modified_gmt":"2025-02-06T11:49:34","slug":"merck-announces-phase-3-waveline-010-trial-initiation-evaluating-zilovertamab-vedotin-an-investigational-antibody-drug-conjugate-for-the-treatment-of-patients-with-previously-untreated-diffuse-large","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/merck-announces-phase-3-waveline-010-trial-initiation-evaluating-zilovertamab-vedotin-an-investigational-antibody-drug-conjugate-for-the-treatment-of-patients-with-previously-untreated-diffuse-large\/","title":{"rendered":"Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma"},"content":{"rendered":"

<\/p>\n

Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma<\/b><\/p>\n

Expansion of the waveLINE clinical development program demonstrates company\u2019s progress in advancing research in hematologic malignancies<\/b><\/p>\n

RAHWAY, N.J.–(BUSINESS WIRE<\/a>)–
\nMerck (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\u2019s 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.<\/p>\n

\n\u201cFollowing 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,\u201d said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. \u201cADCs 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.\u201d<\/p>\n

\nWaveLINE-010 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT06717347<\/a>), 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.<\/p>\n

\nZilovertamab vedotin is currently being evaluated in the Phase 2\/3 waveLINE-003 dose confirmation and expansion trial (NCT05139017<\/a>) for the treatment of relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial (NCT05406401<\/a>) in combination with R-CHP in patients with previously untreated DLBCL. Merck recently presented<\/a> data from this trial for the first time at the 66th<\/sup> American Society of Hematology Annual Meeting and Exposition in December 2024.<\/p>\n

About diffuse large B-cell lymphoma<\/b><\/p>\n

\nLymphoma is cancer beginning in the lymphatic system \u2013 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 \u2013 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%.<\/p>\n

About zilovertamab vedotin (MK-2140)<\/b><\/p>\n

\nZilovertamab 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<\/a>) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401<\/a>).<\/p>\n

About Merck in hematology<\/b><\/p>\n

\nMerck 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\u2019s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies.<\/p>\n

Merck\u2019s focus on cancer<\/b><\/p>\n

\nEvery 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\/research\/oncology<\/a>.<\/p>\n

About Merck<\/b><\/p>\n

\nAt 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 \u2013 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<\/a> and connect with us on X (formerly Twitter)<\/a>, Facebook<\/a>, Instagram<\/a>, YouTube<\/a> and LinkedIn<\/a>.<\/p>\n

Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA<\/b><\/p>\n

\nThis news release of Merck & Co., Inc., Rahway, N.J., USA (the \u201ccompany\u201d) includes \u201cforward-looking statements\u201d 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\u2019s 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.<\/p>\n

\nRisks 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\u2019s 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\u2019s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and\/or regulatory actions.<\/p>\n

\nThe 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\u2019s Annual Report on Form 10-K for the year ended December 31, 2023 and the company\u2019s other filings with the Securities and Exchange Commission (SEC) available at the SEC\u2019s Internet site (www.sec.gov<\/a>).<\/p>\n

\"\"<\/p>\n

View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20250206228342\/en\/<\/a><\/span><\/p>\n

\nMedia Contacts:<\/p>\n

Julie Cunningham
\n
(617) 519-6264<\/p>\n

Sienna Choi
\n
(908) 873-4311<\/p>\n

Investor Contacts:<\/p>\n

Peter Dannenbaum
\n
(732) 594-1579<\/p>\n

Steven Graziano
\n
(732) 594-1583<\/p>\n

KEYWORDS:<\/b> New Jersey United States North America<\/p>\n

INDUSTRY KEYWORDS:<\/b> Oncology Health Clinical Trials General Health Pharmaceutical Biotechnology<\/p>\n

MEDIA:<\/b><\/p>\n\n\n\n\n
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Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma Expansion of the waveLINE clinical development program demonstrates company\u2019s progress in advancing research in hematologic malignancies 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\u2019s investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like … <\/p>\n

Continue reading “Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-809667","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nMerck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/merck-announces-phase-3-waveline-010-trial-initiation-evaluating-zilovertamab-vedotin-an-investigational-antibody-drug-conjugate-for-the-treatment-of-patients-with-previously-untreated-diffuse-large\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma - Market Newsdesk\" \/>\n<meta property=\"og:description\" content=\"Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma Expansion of the waveLINE clinical development program demonstrates company\u2019s progress in advancing research in hematologic malignancies 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). 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