AbbVie Launches Phase 3 Trial for Multiple Myeloma Drug ABBV-383

Today, AbbVie announced the first patient has been treated with ABBV-383 in the CERVINO Phase 3 study. ABBV-383 is a bispecific antibody T-cell engager targeting BCMA and CD3, featuring high BCMA-avidity and low-affinity CD3 binding domains. The Phase 3, multicenter, randomized, open-label study will compare ABBV-383 with standard therapies in patients with relapsed/refractory multiple myeloma (r/r MM) who have received at least two prior therapies.

“Despite treatment advances, most multiple myeloma patients will relapse. Those with advanced disease, especially in the community setting, often lack access to novel treatments and face high treatment burdens,” said Dr. Peter Voorhees of Atrium Health Levine Cancer Institute. “The CERVINO Phase 3 trial aims to evaluate the efficacy of ABBV-383 with monthly dosing.”

Multiple myeloma, a blood cancer characterized by abnormal plasma cell proliferation, is the second most common blood cancer globally. In 2020, an estimated 176,000 people were diagnosed, and 117,000 died from the disease.

“The start of the CERVINO Phase 3 trial underscores AbbVie’s commitment to advancing oncology treatments and improving care for blood cancer patients,” said Dr. Mariana Cota Stirner, AbbVie’s VP of Oncology and Hematology. “ABBV-383 is being tested with monthly dosing to simplify treatment for physicians and patients.”

CERVINO (NCT06158841) is a global, Phase 3, multicenter, randomized, open-label study evaluating ABBV-383 in adult patients (≥18 years) with r/r MM and an ECOG performance status ≤2 who have received at least two prior therapies, including a PI, an IMiD, and an anti-CD38 mAb. Patients with prior BCMA-targeted therapy are excluded. Participants will be randomized to receive intravenous ABBV-383 60mg Q4W or the investigator’s choice of standard available therapies (SAT), continuing until disease progression or other discontinuation criteria are met.

Primary endpoints are progression-free survival and overall response rate. Secondary endpoints include overall survival, complete response, very good partial response, minimal residual disease negativity rate, and changes in disease symptoms and physical functioning.

Approximately 140 global sites will enroll about 380 patients. Additional information is available at under NCT06158841.

ABBV-383 is an investigational BCMA x CD3 bispecific antibody T-cell engager with high-avidity BCMA-binding domains, a low-affinity CD3-binding domain to reduce cytokine release, and a silenced Fc tail for an extended half-life supporting once every 4-week dosing. Its clinical relevance is yet to be established.

BCMA, highly expressed on malignant plasma cells in multiple myeloma, is an ideal therapeutic target, promoting myeloma cell growth and inhibiting apoptosis.

AbbVie is dedicated to transforming cancer care with a dynamic pipeline of investigational therapies for both blood and solid tumors. We focus on targeted treatments to impede cancer cell reproduction or enable their elimination through modalities including ADCs, Immuno-Oncology, and bi-specific and CAR-T platforms. Our team collaborates with innovative partners to deliver potential breakthrough medicines.

Our oncology portfolio includes approved and investigational treatments for various cancers. We are evaluating over 20 investigational medicines across some of the world’s most prevalent and debilitating cancers, committed to helping patients access our cancer therapies.

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