Merck presents data from Phase 2 waveLINE-007 trial

Merck (MRK) announced the first presentation of data from the Phase 2 waveLINE-007 trial evaluating zilovertamab vedotin, Merck’s investigational antibody drug conjugate that targets receptor tyrosine kinase-like orphan receptor 1, in combination with cyclophosphamide, doxorubicin and prednisone plus rituximab for the treatment of patients with previously untreated diffuse large B-cell lymphoma. At a pre-planned analysis, zilovertamab vedotin in combination with R-CHP achieved a 100% complete response rate in patients treated with zilovertamab vedotin at 1.75 mg/kg. Based on the data, the study has established 1.75 mg/kg as the recommended Phase 3 dose of zilovertamab vedotin. These data are being presented for the first time today in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition. The efficacy results showed a CR was achieved in combination with R-CHP in 100% of patients receiving the 1.75 mg/kg dose of zilovertamab vedotin, 93.3% of patients receiving the 2.0 mg/kg dose and 100% of patients receiving the 2.25 mg/kg dose. The total CR rate at the end of treatment was 97.2%. The median follow-up for all patients was 17.6 months. The ORR was 100% for patients receiving the 1.75 mg/kg dose, 93.3% for patients receiving the 2.0 mg/kg dose, and 100% for patients receiving the 2.25 mg/kg dose, all in combination with R-CHP. The median DOR has not been reached for all patients, and the total 12-month DOR was 93.5%. Based on the data, the recommended zilovertamab vedotin dose was determined to be 1.75 mg/kg. Serious treatment-related adverse events occurred in 11% of all patients. Grade 3-4 TRAEs occurred in 58% of all patients.