MSD has commenced the Phase III waveLINE-010 trial to assess its investigational antibody-drug conjugate (ADC), zilovertamab vedotin, combined with rituximab plus cyclophosphamide, doxorubicin, and prednisone (R-CHP), to treat individuals with previously untreated diffuse large B-cell lymphoma (DLBCL).
MSD began worldwide recruitment for the trial and subjects are currently being enrolled.
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In the randomised trial, the combination will be assessed against rituximab with cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) alone.
The open-label trial aims to enrol approximately 1,046 subjects. It will measure progression-free survival (PFS) as its primary endpoint. Secondary endpoints will include safety, overall survival, duration of complete response, event-free survival, and complete response rate (CR) at the end of the treatment.
MSD Research Laboratories oncology clinical research vice-president Dr Gregory Lubiniecki said: “Following the encouraging results observed in the Phase II waveLINE-007 trial, we look forward to evaluating the potential clinical benefits of a combination regimen with zilovertamab vedotin in patients with diffuse large B-cell lymphoma, compared to the current standard treatment.”
The ADC targets the ROR1 transmembrane protein, which is overexpressed in various haematologic malignancies.
It is also under assessment in the Phase II/III waveLINE-003 dose confirmation and expansion trial for relapsed or refractory DLBCL, and in the waveLINE-007 study in conjunction with R-CHP for previously untreated DLBCL.
As a part of its waveLINE clinical programme, MSD aims to explore the ADC across various B-cell malignancies.
The most widespread form of non-Hodgkin lymphoma (NHL), DLBCL accounts for approximately 25%-30% of all NHL cases globally.
It is characterised by fast and uncontrolled growth of white blood cells, leading to enlarged lymph nodes and the potential spread to other body parts.
In December last year, the company reported positive outcomes from two Phase III trials of doravirine/islatravir (DOR/ISL) for adults with virologically suppressed human immunodeficiency virus-1 (HIV-1).
