Merck Launches Pivotal Phase 3 Trial of ROR1 ADC Zilovertamab Vedotin in First-Line DLBCL

▎Armstrong

On February 6, 2025, Merck & Co., Inc. announced the launch of a pivotal Phase III clinical trial for Zilovertamab Vedotin, a ROR1 ADC new drug, in combination with R-CHP versus R-CHOP as a first-line treatment for diffuse large B-cell lymphoma (DLBCL).

WaveLINE-010 plans to enroll 1,046 patients with DLBCL, with the primary endpoint being PFS and secondary endpoints including CR rate, OS, EFS, duration of CR, and safety, among others.

At the 2024 ASH meeting in December, MSD announced the latest data from the Phase II clinical trial waveLINE-007. The CR rates for the 1.75mg/kg, 2.0mg/kg, and 2.25mg/kg dose groups combined with R-CHP were 100%, 93.3%, and 100%, respectively. The overall CR rate was 97.2%, and the 12-month DOR rate was 93.5%.

Zilovertamab vedotin was developed by VelosBio. In November 2020, Merck & Co., Inc. acquired VelosBio for $2.75 billion.

Summary

ADC is a key focus area for MSD, with multiple solid tumor ADCs in clinical stages in collaboration with Kelun Biotech and Daiichi Sankyo. The advancement of ROR1 ADC into a pivotal Phase III trial marks the final Proof of Concept (POC) stage for blood cancer ADCs.