AbbVie, a global biopharmaceutical company, announced the initiation of a phase 3 clinical trial to study the safety and efficacy of venetoclax in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who are considered sensitive or naïve to proteasome inhibitors and have received one to three prior lines of therapy.
The combination of venetoclax, bortezomib and dexamethasone will be compared to treatment with bortezomib, dexamethasone and placebo. Bortezomib, a proteasome inhibitor, and dexamethasone, a corticosteroid, are both common therapies used to treat symptomatic multiple myeloma.
Venetoclax is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the US and by AbbVie outside of the US.
"We have a comprehensive development strategy for venetoclax, with several ongoing clinical trials across a range of hematologic malignancies and multiple lines of therapy as a single agent and in combination with other medicines," said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. "This phase 3 trial represents our commitment to identifying the full potential of this therapy through our clinical development program and is an important step in our goal to provide a possible treatment for multiple myeloma patients."
The randomized, double-blind, placebo-controlled, phase 3 clinical trial aims to recruit approximately 240 patients. The primary efficacy endpoint of the trial is progression-free survival (PFS). Secondary pre-specified outcome measures include overall survival (OS), objective response rate (ORR) and duration of response (DoR), as well as other efficacy and safety outcome measures.
Multiple myeloma is the second most common blood cancer and begins in plasma cells in the bone marrow. When plasma cells in the marrow become cancerous, they can grow uncontrollably and produce abnormal proteins (m proteins) which can cause tumors, typically developing in the bone. When a patient has multiple plasma cell tumors, they have multiple myeloma.
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor currently approved as Venclexta (venetoclax) tablets in the US and indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. The FDA approved this indication under accelerated approval based on overall response rate, and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells. Venclexta was designed to selectively inhibit the BCL-2 protein.
Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. Together, the companies are committed to BCL-2 research with Venclexta, which is currently being evaluated in phase 3 clinical trials for the treatment of relapsed/refractory CLL, along with early phase studies in several cancers. Venclexta is under evaluation by Health Authorities in multiple countries, and not approved for markets outside of the US. AbbVie is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.