AbbVie to Present New Data from Studies of Five Oncology Pipeline Assets in Multiple Cancers at the 51st American Society of Clinical Oncology Annual Meeting

NORTH CHICAGO, Ill., May 11, 2015 /PRNewswire/ -- AbbVie (NYSE: ABBV) announced 17 abstracts from studies of the company's oncology pipeline are being presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), May 29 - June 2, in Chicago. Notably, data will be presented from investigational studies of venetoclax, a B-cell lymphoma-2 (BCL-2) selective inhibitor, in relapsed or refractory multiple myeloma (R/R MM) patients, and veliparib (ABT-888), a poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor, in advanced non-small cell lung cancer (NSCLC) patients with a history of smoking – a factor identified as the number one risk for lung cancer in the United States.[1]

"These data demonstrate our continued commitment to the patients who are affected by a wide variety of cancers," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "AbbVie has a history of developing therapies for patients in need, and our pursuit of new study results for these compounds reinforces our intent to make a significant impact in oncology."

Meeting abstracts are available at http://am.asco.org/abstracts. Compounds mentioned are investigational and are not approved by any health authority. Safety and efficacy have not been established.

Selected presentations in AbbVie's oncology pipeline include:

Venetoclax

• Phase 1 interim safety and efficacy of venetoclax (ABT-199/GDC-0199) monotherapy for relapsed/refractory (R/R) multiple myeloma (MM); S. Kumar, et al.; Abstract 8576; Poster Session; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• Phase 1b interim results: venetoclax in combination with bortezomib (BTZ) and dexamethasone (Dex) in R/R MM C. Touzeau, et al.; Abstract 8580; Poster Session; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• Interim results from a dose-escalation study of the BCL-2 inhibitor venetoclax plus bendamustine (B) and rituximab (R) in patients (pts) with R/R NHL; S. de Vos et al.; Abstract 8535; Poster Session; Sunday, May 31, 2015; 8-11:30 a.m. CDT

Veliparib

• Smoking status predicts sensitivity to PARP inhibitor, veliparib, in patients with advanced NSCLC; S. Ramalingam, et al.; Abstract 8038; Poster Session; Monday, June 1, 2015; 8-11:30 a.m. CDT
• Safety and tolerability of veliparib combined with capecitabine plus radiotherapy in patients with locally advanced rectal cancer (LARC): Final results of a phase 1b study; M. Michael et al.; Abstract 3517; Poster Discussion; Monday, June 1, 2015; 8-11:30 a.m. (Poster), 1-2:30 p.m. (Discussion) CDT

ABT-414

• ABT-414 in patients with advanced solid tumors likely to overexpress the epidermal growth factor receptor (EGFR); Goss, G. et al.; Abstract 2510; Poster Session; Saturday, May 30, 2015; 8-11:30 a.m. CDT
• Phase 1 study of ABT-414 mono-or combination therapy with temozolomide (TMZ) in recurrent glioblastoma (GBM); G.K. Hui et al.; Abstract 2016; Poster Session; Monday, June 1, 2015; 1:15-4:45 p.m. CDT

Elotuzumab

• A randomized Phase 2 study of bortezomib/dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma; A. Jakubowiak et al.; Abstract 8573; Poster Session; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• A Phase 3, randomized, open label study of lenalidomide/dexamethasone with or without elotuzumab in patients with relapsed/refractory multiple myeloma; S. Lonial, et al.; Abstract 8508; Oral Presentation; Tuesday, June 2, 2015; 9:45-12:45 p.m. CDT

Duvelisib

• Early clinical activity and pharmacodynamic effects of duvelisib, a PI3K-delta,gamma inhibitor, in patients with treatment-naive CLL; Patel et al.; Abstract #7074; Poster Session; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• High throughput in vitro combination sensitivity screen in hematologic malignancies with the phosphoinositide-3-kinase (PI3K)-delta,gamma inhibitor, duvelisib; Faia et al.; Abstract #8559; Poster; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• Serum chemokines and cytokines in CLL patients treated with duvelisib, a PI3K-delta,gamma inhibitor; Douglas et al.; Abstract #7072; Poster; Sunday, May 31, 2015; 8-11:30 a.m. CDT
• A phase 1b trial of duvelisib, a PI3K-delta,gamma inhibitor, in combination with obinutuzumab in patients with CLL/SLL previously treated with a Bruton's tyrosine kinase inhibitor (BTKi); Blachly et al.; Abstract # TPS7100; Poster; Sunday May 31, 2015; 8-11:30 a.m. CDT

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 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 Veliparib
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage to cells. Discovered by AbbVie researchers, veliparib is being investigated in combination with DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in multiple cancers and tumor types, including Phase 3 studies in advanced non-small cell lung cancer and breast cancer. Veliparib is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About ABT-414
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics. It is being evaluated for the treatment of patients with EGFR amplified glioblastoma multiforme, a common and aggressive malignant primary brain tumor. In 2014, the FDA and the European Medicines Agency granted orphan drug designation for the treatment of glioblastoma multiforme. ABT-414 is an investigational compound and its efficacy and safety have not been established 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.

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, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including glioblastoma multiforme, 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 more than 26,000 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.

[1] Center for Disease Control and Prevention (2014) "What Are the Risk Factors for Lung Cancer?" http://www.cdc.gov/cancer/lung/basic_info/risk_factors.htm Accessed March 19, 2015.

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