AbbVie Initiates Phase 3 Trial for Promising Multiple Myeloma Treatment
AbbVie has commenced the Phase 3 CERVINO trial to evaluate the efficacy, safety, and tolerability of its investigational asset, ABBV-383, in patients with relapsed/refractory multiple myeloma (r/r MM). This marks a significant advancement in AbbVie’s oncology pipeline, potentially offering a new treatment option for patients who have exhausted other therapies.
Overview of ABBV-383
ABBV-383 is a distinctive B-cell maturation antigen (BCMA) bispecific antibody T-cell engager designed to target BCMA on malignant plasma cells. The drug’s unique composition includes bivalent BCMA-binding domains for high BCMA avidity and a low-affinity CD3-binding domain aimed at reducing cytokine release, thus minimizing side effects. This innovative design supports a once-every-four-weeks (Q4W) dosing schedule, enhancing convenience and compliance for patients.
The CERVINO Study: Objectives and Design
The CERVINO Phase 3 trial (NCT06158841) is a global, multicenter, randomized, open-label study that will enroll approximately 380 patients across 140 sites. It will compare ABBV-383 monotherapy to standard available therapies (SATs) in adult patients with r/r MM who have undergone at least two prior lines of therapy. Patients previously treated with BCMA-targeted therapies will be excluded from the study.
Participants will be randomized to receive either intravenous ABBV-383 at 60mg Q4W or an investigator-chosen SAT regimen, which may include carfilzomib plus dexamethasone, elotuzumab plus pomalidomide plus dexamethasone, or selinexor plus bortezomib plus dexamethasone. The trial’s dual primary endpoints are progression-free survival and overall response rate, with secondary endpoints encompassing overall survival, complete response rates, minimal residual disease negativity, and changes in disease symptoms and physical functioning.
Significance of the Trial
Multiple myeloma is a type of blood cancer characterized by the abnormal proliferation of plasma cells, leading to significant morbidity and mortality. In 2020 alone, approximately 176,000 people globally were diagnosed with multiple myeloma, and 117,000 died from the disease. Despite advances in treatment, most patients will eventually experience a relapse, highlighting the urgent need for new therapeutic options.
“Despite notable advances in treatment, most patients with multiple myeloma will eventually relapse,” said Dr. Peter Voorhees, clinical professor of medicine and director of plasma cell disorders at Atrium Health Levine Cancer Institute. “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.”
Potential Impact on Treatment Paradigms
The CERVINO trial aims to address the unmet needs of patients with r/r MM, particularly those in community settings where access to novel treatments can be limited, and existing therapies often impose a high treatment burden. By offering a potentially more effective and less burdensome treatment option, ABBV-383 could significantly improve patient outcomes and quality of life.
AbbVie’s Commitment to Oncology
AbbVie’s mission in oncology is to transform the standard of care for patients with difficult-to-treat cancers. The company is advancing a dynamic pipeline of investigational therapies across a range of cancer types, including both blood cancers and solid tumors. AbbVie focuses on creating targeted medicines that either impede the proliferation of cancer cells or facilitate their elimination through various modalities such as Antibody Drug Conjugates (ADCs), Immuno-Oncology, and bi-specific and CAR-T platforms.
“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,” said Mariana Cota Stirner, M.D., vice president, therapeutic area head oncology, hematology, AbbVie.
Forward-Looking Statements and Future Directions
As with any investigational drug, the success of ABBV-383 in clinical trials is not guaranteed. AbbVie’s forward-looking statements are subject to risks and uncertainties, including challenges to intellectual property, competition, and inherent difficulties in the research and development process. However, the initiation of the CERVINO Phase 3 trial marks a critical step in AbbVie’s efforts to advance oncology treatments and elevate the standard of care for multiple myeloma patients.
Conclusion
The start of the CERVINO Phase 3 trial represents a significant milestone in AbbVie’s oncology pipeline. ABBV-383, with its innovative design and potential for monthly dosing, could offer a new and improved treatment option for patients with relapsed/refractory multiple myeloma. As AbbVie continues to push the boundaries of cancer treatment, the outcomes of this trial will be eagerly anticipated by the medical community and patients alike.
For more information about the CERVINO study and AbbVie’s oncology initiatives, visit www.abbvie.com/oncology.
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