Merck Begins Phase 3 Trial of Zilovertamab Vedotin for Untreated Diffuse Large B-Cell Lymphoma

RAHWAY, N.J.—Merck, also known as MSD outside the U.S. and Canada, has announced the launch of a pivotal Phase 3 clinical trial named waveLINE-010. This trial is set to investigate the efficacy of a novel treatment involving zilovertamab vedotin combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP). The combination will be compared to the conventional regimen of rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients with untreated diffuse large B-cell lymphoma (DLBCL).

Zilovertamab vedotin is an investigational antibody-drug conjugate (ADC) targeting the receptor tyrosine kinase-like orphan receptor 1 (ROR1). The enrollment of patients in the waveLINE-010 trial has commenced globally.

Dr. Gregory Lubiniecki, Vice President of Oncology Clinical Research at Merck Research Laboratories, highlighted the promising results from the prior Phase 2 waveLINE-007 trial. He expressed optimism about examining the potential benefits of the zilovertamab vedotin combination for treating diffuse large B-cell lymphoma, a form of non-Hodgkin lymphoma. The development of ADCs as a treatment option for various cancers signifies Merck's commitment to addressing the unmet needs in treating this aggressive disease.

WaveLINE-010 is structured as a randomized, open-label Phase 3 study, with an estimated enrollment of 1,046 global participants. The trial's primary focus will be progression-free survival (PFS), while secondary aspects include complete response rate, overall survival, event-free survival, duration of complete response, and safety.

In addition to waveLINE-010, zilovertamab vedotin is under evaluation in several other clinical studies. These include the Phase 2/3 waveLINE-003 trial, assessing the drug's efficacy for relapsed or refractory DLBCL, and the Phase 2 waveLINE-007 trial, exploring its use in newly diagnosed DLBCL patients, both in combination with R-CHP.

Diffuse large B-cell lymphoma, the most prevalent subtype of non-Hodgkin lymphoma, originates from rapidly growing white blood cells that enlarge lymph nodes and often spread throughout the body. This condition accounts for approximately 25-30% of all non-Hodgkin lymphomas globally, with around 25,000 new cases diagnosed annually in the U.S. The five-year relative survival rate for this lymphoma type ranges from 60% to 70%.

Zilovertamab vedotin is an investigational ADC specifically targeting ROR1, a protein found in various hematologic cancers. Merck is advancing its research on zilovertamab vedotin across B-cell malignancies through its waveLINE clinical trial program.

Merck is committed to advancing innovations in treating hematologic cancers, building on its legacy in oncology. The company's comprehensive clinical development program explores novel therapeutic mechanisms to address long-standing unmet needs. Merck's research efforts include studying multiple investigational drugs as standalone or combination treatments for various hematologic cancers.

Merck's dedication to cancer research emphasizes the pursuit of scientific advancements to improve patient outcomes across all cancer stages. With a diverse pipeline of over 25 novel mechanisms and a broad clinical development program covering more than 30 tumor types, Merck aims to drive breakthrough science and enhance access to quality cancer care. By tackling barriers to clinical trial participation, screening, and treatment, Merck strives to reduce disparities and bring life-saving innovations to more cancer patients.

Merck, recognized as MSD outside the U.S. and Canada, harnesses cutting-edge science to save and improve lives worldwide. For over 130 years, the company has been at the forefront of developing life-changing medicines and vaccines, aspiring to be the premier research-driven biopharmaceutical company globally. Through fostering a diverse and inclusive workforce, Merck is committed to ensuring a sustainable and healthy future for all communities.