Phase III Trial for Zilovertamab

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 II 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 III 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 III 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 II/III waveLINE-003 dose confirmation and expansion trial (NCT05139017) for the treatment of relapsed or refractory DLBCL and in the Phase II 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 Annual Meeting and Exposition in December 2024.