By Fineline Cube 
US-based pharmaceutical giant Merck, Sharp & Dohme Inc. (MSD, NYSE: MRK) announced the initiation of the pivotal Phase III waveLINE-010 study. This study is designed to assess zilovertamab vedotin, an investigational antibody-drug conjugate (ADC) targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), in combination with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) alone in patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
Previous Study Results
Zilovertamab vedotin previously demonstrated superior efficacy in the Phase II waveLINE-007 study for patients with newly diagnosed DLBCL. Building on these promising results, the Phase III waveLINE-010 study aims to further evaluate the drug’s potential in a larger patient population.
Study Design and Endpoints
The randomized, open-label Phase III waveLINE-010 study is expected to enroll 1,046 patients worldwide. The primary endpoint is progression-free survival (PFS), with secondary endpoints including the complete response (CR) rate at the end of treatment, overall survival, event-free survival, duration of CR, and safety. This comprehensive evaluation will provide critical insights into the efficacy and safety profile of zilovertamab vedotin in combination therapy for DLBCL.
Future Outlook
With the initiation of the waveLINE-010 study, Merck is poised to advance the clinical development of zilovertamab vedotin. This ADC has the potential to offer a new treatment option for patients with DLBCL, addressing significant unmet medical needs in this area. The results of this study will be crucial in determining the future role of zilovertamab vedotin in the treatment landscape for DLBCL.-Fineline Info & Tech