Merck announced results from the dose confirmation portion of the Phase 2/3 waveLINE-003 study evaluating zilovertamab vedotin in combination with standard of care rituximab and gemcitabine-oxaliplatin (R-GemOx) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is an investigational, potential first-in-class antibody drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). At a pre-planned analysis, zilovertamab vedotin 1.75 mg/kg in combination with R-GemOx achieved a 56.3% objective response rate (ORR) in patients with relapsed or refractory DLBCL (n=16), with eight complete responses (CR) and one partial response (PR). These data are being presented for the first time today during an oral presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #7005).
“Patients with relapsed or refractory diffuse large B-cell lymphoma continue to experience poor outcomes and an unmet need remains to help provide these patients with additional options to treat their cancer,” said Dr. Philippe Armand, the study’s principal investigator, Dana-Farber Cancer Institute. “These data from the Phase 2 portion of the waveLINE-003 trial are encouraging for patients and support further research in the relapsed/refractory setting in a larger patient population.”
“In the Phase 2 portion of the waveLINE-003 trial, the 1.75 mg/kg dose of zilovertamab vedotin with rituximab, gemcitabine and oxaliplatin demonstrated a promising response rate, complete response rate and manageable safety profile in combination with standard of care,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “The Phase 3 portion of this trial is already enrolling, and as we continue to advance our research of this investigational ROR1-directed ADC, these promising results amplify our belief in the potential of zilovertamab vedotin to treat multiple hematologic malignancies.”
Zilovertamab vedotin is currently being evaluated in patients with previously untreated DLBCL in the Phase 3 waveLINE-010 study (NCT06717347) and in the Phase 2 waveLINE-007 study (NCT05406401). Additionally, we recently initiated the Phase 2 waveLINE-011 study (NCT06890884), which is a randomized, open-label clinical trial evaluating zilovertamab vedotin plus rituximab and cyclophosphamide, doxorubicin and prednisone (R-CHP) versus polatuzumab vedotin with R-CHP for the treatment of patients with DLBCL. The trial is estimated to enroll 594 patients and the primary endpoint is CR rate at end of treatment, with secondary endpoints of progression-free survival (PFS), overall survival (OS), event-free survival, duration of CR and safety. Global recruitment of the waveLINE-011 study has begun, with patients now enrolling.
As announced, data spanning more than 25 types of cancer are being presented from Merck’s broad oncology portfolio and investigational pipeline at the 2025 ASCO Annual Meeting.
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