NORTH CHICAGO, IL, USA – July 28, 2016 – AbbVie (ABBV), a global biopharmaceutical company, today 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 U.S. and by AbbVie outside of the U.S.
“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. More information on the Phase 3 trial is available at www.clinicaltrials.gov (NCT02755597).
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.
About VENCLEXTA™ (venetoclax) in the U.S.
Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor currently approved as VENCLEXTA™ (venetoclax) tablets in the U.S. 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 U.S. AbbVie is currently working with regulatory agencies around the world to bring this medicine to eligible patients in need.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world’s most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015 and Stemcentrx in 2016, and through several collaborations, AbbVie’s oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly two hundred clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit https://abbvieoncology.com.
30 July 2016