April 23, 2014

AbbVie to Present Data on Investigational Compounds at the 2014 American Society of Clinical Oncology Annual Meeting

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- Investigators to Present Clinical Trial Findings Evaluating Compounds in Multiple Tumor Types
- Certain Oncology Compounds Currently Being Evaluated in Phase III Studies

NORTH CHICAGO, Ill., April 23, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that data evaluating a number of investigational compounds in the company's oncology pipeline will be presented at the upcoming 50th Annual Meeting of the American Society of Clinical Oncology (ASCO), May 30 - June 3, in Chicago. 

"Our clinical trial program underscores our commitment to developing innovative therapies that improve on current treatment options and create better outcomes for patients," said Gary Gordon, M.D., vice president, Oncology Development, AbbVie. "We have made substantial progress advancing our lead investigational compounds into Phase III testing and remain dedicated to the continued development of the other compounds in our oncology pipeline."

Data will be presented evaluating potential treatments for some of the most widespread and difficult-to-treat cancers. Data accepted for presentation include the results from three clinical trials evaluating the safety and efficacy of ABT-199/GDC-0199, a B-cell lymphoma-2 (BCL-2) selective inhibitor, in chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL) and the results of a Phase I clinical trial of ABT-414, an anti-epidermal growth factor receptor (EGFR) monoclonal antibody drug conjugate, for the treatment of glioblastoma multiforme.

Meeting abstracts are available at http://am.asco.org/abstracts. Highlights include:


  • ABT-199 (GDC-0199) Combined with Rituximab ® in Patients (pts) With Relapsed / Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Interim Results of a Phase 1b Study; S. Ma, et al.; Abstract 7013; May 31, 2014; Poster Session – 1:15-4:15 p.m., Discussion – 4:45-6:00 p.m.
  • ABT-199 (GDC-0199) in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL): High Complete Response Rate and Durable Disease Control; J.F. Seymour, et al.; Abstract 7015; May 31, 2014; Poster Session – 1:15-4:15 p.m., Discussion – 4:45-6:00 p.m.
  • Phase I Study of ABT-199 (GDC-0199) in Patients with Relapsed/Refractory (R/R) non-Hodgkin Lymphoma (NHL): Responses Observed in Diffuse Large B-Cell (DLBCL) and Follicular Lymphoma (FL) at Higher Cohort Doses; M.S. Davids, et al.; Abstract 8522; May 30, 2014; Poster Session – 1:00-4:00 p.m., Discussion – 4:30-5:45 p.m.


  • A Phase I Study Evaluating ABT-414 in Combination with Temozolomide (TMZ) for Subjects with Recurrent or Unresectable Glioblastoma (GBM); H.K. Gan, et al.; Abstract 2021; May 30, 2014; Poster Session – 1:00-4:00 p.m., Discussion – 4:30 -5:45 p.m.

Veliparib (ABT-888)

  • The Safety and Tolerability of Veliparib (V) plus Capecitabine © and Radiation (RT) in Subjects with Locally Advanced Rectal Cancer (LARC): Results of a Phase Ib Study; B. Czito, et al.; Abstract 3634; May 31, 2014; Poster Session – 8:00-11:45 a.m.
  • A Phase 1 Dose-Escalation Study of Veliparib with Bimonthly FOLFIRI in Patients with Advanced Solid Tumors; J. Berlin, et al.; Abstract 2574; June 1, 2014; Poster Session – 8:00-11:45 a.m.

About ABT-199/GDC-0199
ABT-199/GDC-0199 is an investigational, selective inhibitor of the B-cell lymphoma-2 (BCL-2) protein being evaluated for the treatment of patients with various cancer and tumor 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. As a BCL-2 homology domain-3 (BH3) -mimetic drug, ABT-199/GDC-0199 is designed to block the function of the BCL-2 protein by restoring the communication system that tells cancer cells to self-destruct. ABT-199/GDC-0199 is being developed in collaboration with Genentech in the United States and Roche outside the United States. Together, the companies are pioneering BCL-2 research with ABT-199/GDC-0199, which is currently being evaluated in a Phase III clinical trial for the treatment of CLL and several other cancers.

About Veliparib (ABT-888)
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]–ribose) polymerases (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body that repairs damage to DNA, and in certain types of cancers, repairs cancer cells. Discovered and developed by AbbVie researchers, Veliparib (ABT-888) is being developed to help prevent DNA repair in cancer cells and increase the effectiveness of common DNA-damaging therapies like chemotherapy or radiation. Veliparib (ABT-888) is currently being studied in more than a dozen cancers and tumor types, including Phase III studies in breast cancer and non-small cell lung cancer.

About ABT-414
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells, thereby reducing the toxic side effects of traditional chemotherapy while enhancing anti-tumor activity. Being developed by AbbVie researchers, ABT-414 is currently being investigated in Phase I/II for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors.

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.

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.



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