AbbVie Begins Phase 3 Trial of ABBV-383 for Multiple Myeloma

North Chicago, Ill. – June 5, 2024 – AbbVie has initiated treatment for the first patient in the Phase 3 CERVINO study, evaluating ABBV-383, a BCMA bispecific antibody T-cell engager, in patients with relapsed/refractory multiple myeloma (r/r MM).

Overview of ABBV-383 and Its Mechanism

ABBV-383 is a unique bispecific antibody that targets B-cell maturation antigen (BCMA) and CD3. It features high-avidity BCMA-binding domains and a low-affinity CD3 binding domain, fostering strong BCMA engagement with reduced cytokine release. This structure aims to maximize therapeutic efficacy while minimizing adverse effects. ABBV-383 is designed with a silenced Fc tail to extend its half-life, potentially allowing for once-monthly dosing.

Details of the CERVINO Phase 3 Study

CERVINO (NCT06158841) is a global, randomized, open-label, multicenter trial aimed at assessing the efficacy, safety, and tolerability of ABBV-383 in adult patients with r/r MM. Eligible participants must have undergone at least two prior lines of therapy, including proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), and anti-CD38 monoclonal antibodies (mAbs). The study excludes individuals previously treated with BCMA-targeted therapies.

Participants will be randomized in a 1:1 ratio to receive either intravenous ABBV-383 at 60mg every four weeks or an investigator-selected standard available therapy (SAT), which includes combinations like carfilzomib + dexamethasone, elotuzumab + pomalidomide + dexamethasone, or selinexor + bortezomib + dexamethasone. Treatment continues until disease progression or other discontinuation criteria are met.

The dual primary endpoints for the study are progression-free survival and overall response rate. Secondary endpoints encompass overall survival, complete response rates, very good partial response rates, minimal residual disease negativity, and changes in disease symptoms and physical functioning. The study aims to enroll approximately 380 patients across 140 global sites.

Significance and Expectations

Dr. Peter Voorhees, a clinical professor and director at Atrium Health Levine Cancer Institute, noted the importance of the CERVINO trial in providing a potentially simpler treatment regimen with monthly dosing for patients with advanced multiple myeloma. Despite advancements, many patients with multiple myeloma face relapse, and treatment options often come with significant burdens.

Mariana Cota Stirner, M.D., vice president of oncology and hematology at AbbVie, highlighted the company's ongoing commitment to advancing oncology treatments. The initiation of the CERVINO trial represents a significant step in AbbVie's efforts to develop new therapeutic approaches and improve standards of care for blood cancer patients.

Understanding Multiple Myeloma

Multiple myeloma is a type of blood cancer characterized by the abnormal proliferation of plasma cells. This condition can cause extensive end-organ damage and is the second most prevalent blood cancer globally. In 2020, approximately 176,000 people were diagnosed with multiple myeloma worldwide, with 117,000 fatalities.

BCMA is prominently expressed on the surface of malignant plasma cells in multiple myeloma, making it a prime target for therapeutic intervention. By promoting cell growth and inhibiting programmed cell death, BCMA contributes significantly to the survival of myeloma cells.

AbbVie's Broader Oncology Initiatives

AbbVie is dedicated to transforming cancer treatment standards through a dynamic pipeline of investigational therapies. The company focuses on developing targeted medicines for both blood cancers and solid tumors, utilizing a variety of treatment modalities such as antibody-drug conjugates, immuno-oncology, and CAR-T platforms. AbbVie collaborates with innovative partners to expedite the development of potential breakthrough therapies.

The company's expansive oncology portfolio includes approved and investigational treatments for numerous cancers. AbbVie is committed to ensuring patient access to these therapies and continues to explore new solutions to address significant health challenges in oncology.

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