November 17, 2014

AbbVie to Present Data on Investigational Oncology Compounds at the 56th American Society of Hematology Annual Meeting

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Data from 13 accepted abstracts include:
- New Results from a Phase 2 Study of Venetoclax (formerly ABT-199/GDC-0199) in Patients with Acute Myelogenous Leukemia (AML)
- Several Studies of Elotuzumab in Patients with Multiple Myeloma, Including Final Results from a Phase 1b/2 Study
- Results from Phase 1 studies of Duvelisib in Patients with Chronic Lymphocytic Leukemia

NORTH CHICAGO, Ill., Nov. 17, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) will present data evaluating three investigational compounds from the company's oncology pipeline at the upcoming 56th American Society of Hematology Annual Meeting (ASH), December 6-9, in San Francisco. Data will be highlighted in 13 accepted abstracts, including several oral presentations detailing new trial results from the venetoclax program in acute myelogenous leukemia, elotuzumab in multiple myeloma, and duvelisib in patients with chronic lymphocytic leukemia and indolent non-Hodgkin's lymphoma.  

"AbbVie is committed to developing potential new cancer medicines for patients and their care providers who are in need of additional treatment options," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "This is an important time for AbbVie's oncology development program, with researchers presenting an unprecedented number of studies of our late-stage assets in several types of blood cancer."

Meeting abstracts are available at https://ash.confex.com/ash/2014/webprogram/start.html.  

AbbVie's abstract presentations include:

Venetoclax (formerly ABT-199/GDC-0199)

  • The BCL-2 Inhibitor ABT-199 (GDC-0199) in Combination with Bendamustine and Rituximab in Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma; S. de Vos, et al.; Abstract 1722; Poster Session; Saturday, December 6, 2014; 5:30-7:30 p.m. PST
  • A Phase 2 Study of ABT-199 (GDC-0199) in Patients with Acute Myelogenous Leukemia (AML); M. Konopleva, et al.; Abstract 118; Oral Session; Sunday, December 7, 2014; 5:15 p.m. PST
  • Determination of Recommended Phase 2 Dose of ABT-199 (GDC-0199) Combined with Rituximab ® in Patients With Relapsed / Refractory (R/R) Chronic Lymphocytic Leukemia (CLL); A.W Roberts, et al.; Abstract 325; Oral Session; Monday, December 8, 2014; 7:00 a.m. PST
  • Preliminary Results of a Phase 1b Study (GP28331) Combining GDC-0199 (ABT-199) and Obinutuzumab in Patients with Relapsed/Refractory or Previously Untreated Chronic Lymphocytic Leukemia; I. Flinn, et al.; Abstract 4687; Poster Session; Monday, December 8, 2014; 6:00 p.m. PST

Elotuzumab

  • Final Results for the 1703 Phase 1b/2 Study of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; P. Richardson, et al.; Abstract 302; Oral Session; Monday, December 8, 2014; 7:15 a.m. PST
  • Pharmacokinetics and Safety of Elotuzumab in Combination with Lenalidomide and Dexamethasone in Patients with Multiple Myeloma and Various Levels of Renal Function: Results of a Phase 1b Study; J. Berdeja, et al.; Abstract 2119; Poster Session; Saturday, December 6, 2014; 5:30 p.m. PST
  • An Ongoing Multinational Observational Study in Multiple Myeloma (PREAMBLE): Initial Assessment of Treatment Patterns in Patients with > 6 Months Follow-up; D. Cella, et al.; Abstract 1297; Poster Session; Saturday, December 6, 2014; 5:40 p.m. PST
  • Initial Report on Phase I Trial of RVD-Elotuzumab for Newly Diagnosed High Risk Multiple Myeloma; Usmani, et al.; Abstract 4762; Poster Session; Monday, December 8, 2014; 6:00 p.m. PST

Duvelisib

  • Duvelisib (IPI-145), a PI3K-?,? Inhibitor, Is Clinically Active in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia; S. O'Brien, et al.; Abstract 3334; Poster Session; Sunday, December 7, 2014, 6:00 p.m. PST
  • Clinical Activity of Duvelisib (IPI-145), a Phosphoinositide-3-Kinase-?,? Inhibitor, in Patients Previously Treated with Ibrutinib; P. Porcu, et al.; Abstract 3335; Poster Session; Sunday, December 7, 2014, 6 p.m. PST
  • Duvelisib (IPI-145) Inhibits Malignant B-Cell Proliferation and Disrupts Signaling from the Tumor Microenvironment through Mechanisms That Are Dependent on PI3K-? and PI3K-?; M. Peluso, et al.; Abstract 328; Oral Presentation; Monday, December 8, 2014, 7:45 a.m. PST
  • A Phase 1 Evaluation of Duvelisib (IPI-145), a PI3K-?,? Inhibitor, in Patients with Relapsed/Refractory iNHL; I. Flinn, et al.; Abstract 802; Oral Presentation; Tuesday, December 9, 2014, 8:15 a.m. PST
  • Duvelisib (IPI-145), a Phosphoinositide-3-Kinase-?,? Inhibitor, Shows Activity in Patients with Relapsed/Refractory T-Cell Lymphoma; S. Horowitz, et al.; Abstract 803; Oral Presentation; Tuesday, December 9, 2014, 8:30 a.m. PST

About Venetoclax (formerly ABT-199/GDC-0199)
Venetoclax is an investigational inhibitor of the B-cell lymphoma-2 (BCL-2) protein being evaluated for the treatment of patients with various cancer types. The BCL-2 protein 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. Venetoclax is designed to block the function of the BCL-2 protein leading to the restoration of the communication system that tells cancer cells to self-destruct. Venetoclax is being developed in collaboration with Roche-Genentech. Together, the companies are pioneering BCL-2 research with venetoclax, which is currently being evaluated in a Phase 3 clinical trial for the treatment of CLL and several other cancers. Venetoclax is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About Elotuzumab
Elotuzumab is an investigational antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7), a cell-surface glycoprotein that is highly and uniformly expressed on multiple myeloma cells but is minimally expressed on normal cells. AbbVie and Bristol Myers Squibb are co-developing elotuzumab in Phase 3 development, and are investigating whether through both direct activation and engagement of NK cells, elotuzumab may selectively target and kill SLAMF7 expressing myeloma cells. In May 2014, the U.S. FDA granted elotuzumab Breakthrough Therapy Designation for use in combination with one of the chemotherapy treatments for multiple myeloma (lenalidomide, used in combination with dexamethasone) in patients who have received one or more prior treatments. Elotuzumab is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About Duvelisib
Duvelisib is an investigational inhibitor of phosophoinositide-3-kinase (PI3K)-delta and PI3K-gamma that is being jointly developed by AbbVie and Infinity Pharmaceuticals Inc. The PI3K pathway is known to play a critical role in regulating the growth and survival of certain types of blood cancers. Duvelisib is designed to block the growth and survival of tumor cells by inhibiting PI3K-delta and PI3K-gamma signaling. The investigational agent is currently in Phase 2 (DUO™) and 3 (DYNAMO™) clinical studies for the treatment of patients with indolent non-Hodgkin lymphoma and chronic lymphocytic leukemia. Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

About AbbVie Oncology
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. For more information on AbbVie Oncology and our oncology portfolio, please visit http://oncology.abbvie.com.

About AbbVie
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. AbbVie employs approximately 25,000 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.

SOURCE AbbVie

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