Start of multiple myeloma phase III clinical trial for investigational asset ABBV 383

ABBV 383 is a distinctive B-cell maturation antigen (BCMA) and CD3 bispecific antibody T-cell engager composed of bivalent BCMVA-binding domains allowing for high BCMA-avidity and a low-affinity CD3 binding domain.

ABBV 383 is being evaluated in a Phase III, 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.

"Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse. Patients with advanced disease, especially in the community setting, often have limited access to novel treatment options and existing options have a high treatment burden, including frequent dosing," said Dr. Peter Voorhees, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute. "The CERVINO Phase III trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges."

"The start of the CERVINO Phase III trial marks an important step forward in AbbVie's continued commitment to advance new oncology treatments and elevate the standard of care for blood cancer patients," said Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie. "ABBV 383 is being evaluated with monthly dosing from the beginning of treatment, with the goal of maximizing treatment simplicity for physicians and patients, if proven in the clinical trials."

About the CERVINO Study

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.