AbbVie to Present Data on Investigational Anti-Cancer Compounds at American Society of Clinical Oncology Annual Meeting
Enrollment in Phase 1 Clinical Trials of ABT-199 in Chronic Lymphocytic Leukemia Continues
NORTH CHICAGO, Ill., May 15, 2013 /PRNewswire/ — AbbVie (NYSE: ABBV) today announced that data evaluating several investigational compounds in the company’s oncology pipeline will be presented at the upcoming 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, May 31 – June 4, Chicago. Data being presented include the results from two clinical trials evaluating the safety and efficacy of ABT-199, a BCL-2 selective inhibitor, in chronic lymphocytic leukemia (CLL) and non-Hodgkin’s lymphoma (NHL).
Meeting abstracts are available today at http://chicago2013.asco.org/abstracts.
“These presentations further solidify our commitment to addressing the unmet need for new therapies that can improve on current treatment options for patients with cancer,” said Gary Gordon, M.D., divisional vice president, oncology clinical development, AbbVie. “With our pioneering research, we are breaking new ground in some of the most widespread and difficult-to-treat cancers.”
- Updated Results of a Phase I First-In-Human Study of the BCL-2 Inhibitor ABT-199 (GDC-0199) in Patients with Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL); J.F. Seymour, et al.; Abstract 7018; Poster Discussion Session; June 1, 2013; 8:00 a.m.-12:00 p.m.
- Updated Results of a Phase I First-In-Human Study of the BCL-2 Inhibitor ABT-199 (GDC-0199) in Patients with Relapsed/Refractory (R/R) non-Hodgkin’s Lymphoma (NHL); M.S. Davids, et al.; Abstract 8520; Oral Presentation; June 3, 2013; 11:30 a.m.-1:30 p.m.
- A Phase I/II Study of Elotuzumab (Elo) plus Lenalidomide/Dexamethasone in Relapsed/Refractory (R/R) Multiple Myeloma: Updated Phase II results and Phase I/II long-term safety; S. Lonial, et al.; Abstract 8542; Poster Discussion Session; June 3, 2013; 1:15 p.m.-5:15 p.m.
- A Phase I Study of Veliparib (ABT-888) in Combination with Carboplatin and Gemcitabine in Subjects with Advanced Solid Tumors; K. M. Bell-McGuinn, et al.; Abstract 2485; Poster Discussion Session; June 3, 2013; 8:00 a.m.-11:45 a.m.
- A phase I and Biodistribution Study of ABT-806i, an 111 Iindium-Labeled Conjugate of the Tumor-Specific Anti-EGFR Antibody ABT-806; H.K. Gan, et al.; Abstract 2520; Poster Discussion Session; June 4, 2013; 8:00 a.m.-12:30 p.m.
ABT-199 is a selective inhibitor of B-cell lymphoma-2 (BCL-2) proteins. The B-cell lymphoma 2 gene prevents apoptosis of some cells including lymphocytes, and can be highly expressed in cancers in the lymph nodes, spleen, and other organs of the immune system. As a BH3-mimetic, ABT-199 is designed to block the function of the BCL-2 protein by restoring the communication system that tells cancer cells to self-destruct. Jointly developed by AbbVie and Genentech, the companies are pioneering BCL-2 research with ABT-199, which is currently in Phase 1/1b clinical trials for the treatment of CLL, the most common leukemia in the United States, and several other cancers.
The U.S. Food and Drug Administration (FDA) recently accepted AbbVie’s amended clinical trial protocols for studies of ABT-199 in patients with CLL and enrollment for ABT-199 clinical trials in CLL, NHL and multiple myeloma has been re-instated. AbbVie and Genentech expect to move ABT-199 into later-stage clinical trials in the near future.
Elotuzumab is a humanized monoclonal antibody that targets against CS1, a cell-surface glycoprotein that is highly expressed on multiple myeloma cells. Two Phase 3 studies of elotuzumab in combination with lenalidomide and low-dose dexamethasone at a dose of 10 mg/kg are ongoing in patients with newly-diagnosed (ELOQUENT1) and relapsed/refractory multiple myeloma (ELOQUENT2). Elotuzumab is being jointly developed by AbbVie and Bristol-Myers Squibb.
About ABT-888 (Veliparib)
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]-ribose) polymerases (PARPs) inhibitor being evaluated in multiple tumor types. PARP is a naturally occurring enzyme in the body that repairs damage to DNA, and contributes to chemotherapy resistance in cancer cells. Discovered and developed by AbbVie researchers, ABT-888 (veliparib) is being developed to increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in more than a dozen cancers and tumor types, including Phase 2 studies in a variety of cancers, including breast, ovarian, non small-cell lung and gastrointestinal cancers.
ABT-806i is an immunoradiopharmaceutical formed by labeling monoclonal antibody ABT?806 with indium 111 ((111)In). The antibody portion of the radiopharmaceutical, ABT-806, is a humanized antibody specific for an epitope of EGFR; and epitope that is exposed in deletion variant EGFRde2-7 (EGFRvIII) or when wild-type EGF receptors are amplified, overexpressed, or activated. This epitope provides for the opportunity to use ABT-806i as an imaging agent for the identification and characterization of solid tumor malignancies expressing EGFR, including those expressing deletion variant EGFRde2-7. ABT-806 was in-licensed by AbbVie from Life Science Pharmaceuticals.
About AbbVie Oncology
The fight against cancer is one of the greatest battles in medicine and the varied nature of the disease requires a diverse approach that looks at multiple disease targets in a variety of tumor types. AbbVie’s oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types.
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. 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. In 2013, AbbVie employs approximately 21,000 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.