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Merck’s Zilovertamab Vedotin Shows Promising Results in First-Line Treatment of DLBCL

NextEdge Admin

09 Dec 2024

2 min 23 sec

antibody-drug conjugate,66th ASH Annual Meeting

Merck , known as MSD outside the U.S. and Canada, presented data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, an investigational ROR1-targeting antibody-drug conjugate (ADC), combined with R-CHP (rituximab, cyclophosphamide, doxorubicin, and prednisone) for untreated diffuse large B-cell lymphoma (DLBCL). Results were shared at the 66th ASH Annual Meeting.

The study established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin. In this arm, a 100% complete response (CR) rate (n=15) was achieved, with an objective response rate (ORR) also at 100%. Across all doses, the CR rate was 97.2%, and the median duration of response (DOR) was not reached, with a 12-month DOR of 93.5%. Serious treatment-related adverse events (TRAEs) occurred in 11% of patients, with Grade 3-4 TRAEs in 58%, primarily neutropenia, nausea, anemia, and diarrhea.

DLBCL, the most common non-Hodgkin lymphoma subtype, accounts for 25-30% of cases globally. Despite current treatments, ~40% of patients face relapsed or refractory disease, highlighting the unmet need for effective first-line therapies.

Zilovertamab vedotin targets ROR1, a transmembrane protein overexpressed in various hematologic cancers. Merck's waveLINE clinical program aims to evaluate its potential across B-cell malignancies, including Phase 2/3 and Phase 3 trials in relapsed/refractory and treatment-naïve DLBCL patients.

Dr. Muhit Ozcan, the study’s lead investigator, noted the promising efficacy and manageable safety of zilovertamab vedotin, supporting further research in larger populations. Dr. Gregory Lubiniecki of Merck emphasized the ADC’s potential to transform DLBCL treatment and beyond.