AbbVie announced that the first patient has been treated with investigational ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain. ABBV-383 is being evaluated in a Phase 3, multicenter, randomized, open-label study compared with standard available therapies in patients with r/r MM who received at least two lines of prior therapy.

Multiple myeloma is a blood cancer characterized by abnormal proliferation of plasma cells, which can cause end-organ damage and is the second most commonly occurring blood cancer in the world. An estimated 176,000 people globally were diagnosed with multiple myeloma in 2020, and 117,000 people died from the disease. CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label, parallel-group study evaluating ABBV-383 in adult patients (=18 years) with r/r MM and an Eastern Cooperative Oncology Group performance status =2 who received at least two prior lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.

Patients who received prior BCMA-targeted therapy will be excluded. Patients will be randomized 1:1 to receive intravenous ABBV-383 60mg Q4W or the investigator's choice of SAT (carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone), and will continue treatment until confirmed progressive disease or other discontinuation criteria are met. The dual primary end points are progression-free survival and overall response rate.

Secondary end points include overall survival, complete response (CR) or better, very good partial response or better, rate of minimum residual disease negativity, and change in disease symptoms and physical functioning. Approximately 140 sites globally will enroll approximately 380 total patients.