On February 6, 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported 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) (Press release, Merck & Co, FEB 6, 2025, View Source [SID1234650084]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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 66th American Society of Hematology (ASH) (Free ASH Whitepaper) 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).