AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383

Core Insights - AbbVie has initiated the CERVINO Phase 3 trial to evaluate the efficacy, safety, and tolerability of ABBV-383 in patients with relapsed/refractory multiple myeloma (r/r MM) who have received at least two prior lines of therapy [1][2][3] - ABBV-383 is a bispecific antibody T-cell engager targeting B-cell maturation antigen (BCMA) and CD3, designed for monthly dosing to improve treatment simplicity for patients and physicians [1][2][5] Study Details - The CERVINO study is a global, multicenter, randomized, open-label trial involving adult patients (≥18 years) with r/r MM, excluding those who have received prior BCMA-targeted therapy [3][4] - Patients will be randomized 1:1 to receive either ABBV-383 60mg every 4 weeks or standard available therapies, with treatment continuing until disease progression or other discontinuation criteria are met [3][4] Endpoints and Enrollment - The primary endpoints of the study are progression-free survival and overall response rate, with secondary endpoints including overall survival and rates of complete response [4] - Approximately 380 patients will be enrolled across 140 sites globally [4] About ABBV-383 - ABBV-383 features bivalent high-avidity BCMA-binding domains and a low-affinity CD3-binding domain to reduce cytokine release, potentially allowing for extended dosing intervals [5] - BCMA is highly expressed on malignant plasma cells in multiple myeloma, making it a critical target for therapy [5][6] AbbVie's Commitment to Oncology - AbbVie is focused on transforming standards of care for patients with difficult-to-treat cancers, advancing a pipeline of investigational therapies across various cancer types [6][7] - The company is evaluating over 20 investigational medicines targeting widespread and debilitating cancers, aiming to improve patient access to cancer treatments [7]