First R/R Myeloma Patient Treated with New BCMA-Directed Bispecific Antibody in Phase 3 Study

AbbVie announced on June 5, 2024, that the first relapsed/refractory myeloma patient in their phase 3 study started treatment with the new BCMA-directed bispecific antibody called ABBV-383. 

"The start of the CERVINO Phase 3 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. 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."  -Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie. 

Read more about this important study below! 

What is ABBV-383? 

ABBV-383 is an “off-the-shelf” medicine, meaning it is ready for immediate use. This new bispecific antibody works by attaching to two targets: a surface protein called CD3 on cancer-killing T-cells and a surface protein on myeloma cells called BCMA (B-cell maturation antigen). This dual binding brings T-cells close enough to kill myeloma cells. This mechanism of action is helpful as T-cells often have difficulty finding and destroying myeloma cells on their own. 

ABBV-383 is being evaluated in a phase 3 clinical trial called the Cervino study for myeloma patients whose disease returned or became resistant after prior therapy (relapsed/refractory). In a phase 3 trial, the new medicine is compared against standard therapies. 

Where Can I Receive ABBV-383? 

The Cervino clinical trial is open and recruiting up to 380 relapsed/refractory myeloma patients who have had at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. 

Patients who join the study will be randomized into one of two groups. The first group receives ABBV-383, and the second is treated with standard myeloma therapies such as carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone. Separating patients into treatment groups helps investigators evaluate how effective ABBV-383 is compared to standard myeloma therapies. 

ABBV-383 will be administered to myeloma patients as an infusion into the vein every month for up to 3.5 years. Treatment may stop during that time if myeloma progresses despite therapy or another discontinuation criteria is met. 

Click here to read more about the study’s eligibility requirements. If you would like to receive ABBV-383, please contact the trial’s representative by emailing abbvieclinicaltrials@abbvie.com or calling 844-663-3742. Although study locations currently only list facilities in Israel and Taiwan, approximately 140 global treatment locations are anticipated to be part of this clinical trial. Please contact the trial's representative to review if one of the treatment centers administering ABBV-383 may become available near you. 

"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. The CERVINO Phase 3 trial is designed to evaluate the efficacy of ABBV-383 with monthly dosing and we look forward to seeing the data as it emerges." -Dr. Peter Voorhees, clinical professor of medicine, director of plasma cell disorders, Atrium Health Levine Cancer Institute. 

HealthTree looks forward to the data gained from the Cervino study in hopes that it will provide an additional effective treatment option for the relapsed/refractory myeloma community. 

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Sources:

• AbbVie Advances Oncology Pipeline With Start of Multiple Myeloma Phase 3 Clinical Trial for Investigational Asset ABBV-383 
• Study Assessing Activity of Intravenous (IV) ABBV-383 Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma