June 8, 2015

AbbVie to Present Data from Studies of the Company's Oncology Pipeline at the 20th European Hematology Association Annual Congress

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Oral presentations include:
- Phase 1b study evaluating investigational medicine venetoclax combined with rituximab in relapsed/refractory CLL
- Dose-escalation study evaluating investigational medicine venetoclax in combination with an immunochemotherapy regimen, bendamustine and rituximab, in patients with NHL

NORTH CHICAGO, Ill., June 8, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced it will present data on its investigational hematological malignancy medicines at the 20th European Hematology Association Annual Congress (EHA), June 11-14, in Vienna. Notable data include an oral presentation of venetoclax, an investigational B-cell lymphoma-2 (BCL-2) selective inhibitor, in combination with rituximab in relapsed or refractory chronic lymphocytic leukemia (R/R CLL) patients.

"These data provide further evidence of the depth of our pipeline and commitment to treating cancers of the blood," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "AbbVie will continue to investigate difficult-to-treat cancers and develop medicines in an effort to make an impact for patients affected by cancer."

Meeting abstracts are available at www.ehaweb.org. Medicines mentioned are investigational and are not approved by any health authority. Safety and efficacy have not been established.

Presentations of potential new medicines in AbbVie's oncology pipeline include:

Venetoclax

  • Venetoclax (ABT-199 / GDC-0199) combined with rituximab induces deep responses in patients with relapsed/refractory chronic lymphocytic leukemia; AW Roberts et al.; Abstract S431; Oral Presentation; Saturday, June 13, 2015; 11:30-11:45 a.m. CEST
  • A dose-escalation study of the BCL-2 inhibitor venetoclax (ABT-199/GDC-0199) plus bendamustine (B) and rituximab ® in patients (pts) with relapsed/refractory (R/R) Non-Hodgkin's Lymphoma (NHL); Sven de Vos et al.; Abstract S109; Oral Presentation; Friday, June 12, 2015; 12:15-12:30 p.m. CEST
  • Phase 1b results of venetoclax (ABT-199/GDC-0199) in combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma ; P. Moreau et al.; Abstract P289; Poster Presentation; Friday, June 12, 2015; 5:15-6:15 p.m. CEST
  • Venetoclax (ABT-199/GDC-0199) monotherapy for relapsed/refractory multiple myeloma: Phase 1 safety and efficacy; Kumar S; Abstract P658; Poster Presentation; Saturday, June 13, 2015; 5:15-6:45 p.m. CEST

Elotuzumab

  • Eloquent-2: A Phase 3, randomized, open-label study of lenalidomide/dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma; Tang J; Abstract S471; Presidential Symposium; Friday, June 12, 2015; 3:45-4:00 p.m. CEST
  • A randomized, open-label, Phase 2 study of bortezomib and dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma; Tang J; Abstract S103; Oral Presentation; Saturday, June 12, 2015; 12:00-12:15 p.m. CEST

Duvelisib

  • Early clinical activity and pharmacodynamic effects of duvelisib, a PI3K-delta,gamma inhibitor, in patients with treatment-naïve CLL; O'Brien et al.; Abstract S434; Oral Presentation; Saturday, June 13, 2015; 12:15-12:30 p.m. CEST
  • Duvelisib (ipi-145) inhibits malignant B-cell proliferation and disrupts signaling from the tumor microenvironment through mechanisms that are dependent on PI3K-delta and PI3K-gamma; Peluso et al.; Abstract P361; Poster Presentation; 5:15-6:45 p.m. CEST

About Venetoclax

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor 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 expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein. Venetoclax is being developed in collaboration with Genentech and Roche. Together, the companies are committed to BCL-2 research with venetoclax, which is currently being evaluated in Phase 3 clinical trials for the treatment of first-line and relapsed/refractory CLL, along with studies in several other cancers. In 2015, the FDA granted Breakthrough Therapy Designation to venetoclax for the treatment of CLL in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. 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 monoclonal antibody targeted against Signaling Lymphocyte Activation Molecule (SLAMF7), a cell-surface glycoprotein that is highly expressed on multiple myeloma cells and Natural Killer (NK) cells. Elotuzumab is being investigated to determine whether through both direct activation and engagement of NK cells, the compound may target and kill SLAMF7 expressing myeloma cells. In 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. AbbVie and Bristol-Myers Squibb are co-developing elotuzumab, with Bristol-Myers Squibb leading the commercialization of the agent.

About Duvelisib

Duvelisib is an investigational dual inhibitor of phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma, two proteins that are known to help support the growth and survival of malignant B-cells. PI3K-delta signaling can lead to the proliferation of malignant B-cells, and both PI3K-gamma and PI3K delta play a role in the formation and maintenance of the supportive tumor microenvironment. AbbVie and Infinity Pharmaceuticals, Inc. are jointly developing duvelisib in various cancer types.

Duvelisib is being evaluated in several studies, including a Phase 2 study in patients with refractory indolent non-Hodgkin lymphoma, a Phase 3 study in patients with previously treated follicular lymphoma and a Phase 3 study in patients with relapsed/refractory 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, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers, including glioblastoma multiforme, multiple myeloma and chronic lymphocytic leukemia. AbbVie's 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 AbbVie's 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. 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.

 

SOURCE AbbVie

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