Merck (NYSE: MRK), known as MSD outside the United States and Canada, has initiated waveLINE-010, a pivotal Phase 3 clinical trial. The study evaluates zilovertamab vedotin in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard regimen of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for previously untreated diffuse large B-cell lymphoma (DLBCL). The trial has begun global recruitment, and patient enrollment is underway.
Advancing Treatment for DLBCL
Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, highlighted the potential impact of this trial. “Encouraging results from the Phase 2 waveLINE-007 trial motivate us to explore the benefits of this combination regimen. Antibody-drug conjugates (ADCs) have shown great promise, and this trial reaffirms our commitment to advancing cancer treatment.”
WaveLINE-010 Trial Details
As per the press release, this randomized, open-label Phase 3 trial (NCT06717347) aims to enroll approximately 1,046 patients worldwide. The primary endpoint is progression-free survival (PFS), while secondary endpoints include complete response (CR) rate, overall survival, event-free survival, duration of CR, and safety.
Current Research on Zilovertamab Vedotin
Merck is also evaluating zilovertamab vedotin in the Phase 2/3 waveLINE-003 trial (NCT05139017) for relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial (NCT05406401) for previously untreated DLBCL. The latest data from waveLINE-007 was presented at the 66th American Society of Hematology Annual Meeting in December 2024.
Understanding Diffuse Large B-Cell Lymphoma
DLBCL, the most common form of non-Hodgkin lymphoma (NHL), arises from rapidly growing white blood cells. It affects approximately 25,000 people in the U.S. annually, with a five-year survival rate of 60-70%.
About Zilovertamab Vedotin (MK-2140)
Zilovertamab vedotin is an investigational ADC targeting ROR1, a transmembrane protein overexpressed in multiple hematologic malignancies. Merck continues to expand its waveLINE clinical trial program to advance treatments for B-cell malignancies.