AbbVie Reinforces Commitment to Hematologic Oncology at 21st European Hematology Association Annual Congress Including 10 Abstracts on Investigational Medicine Venetoclax

COPENHAGEN, Denmark, June 9, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, will present data on its investigational medicine venetoclax, a B-cell lymphoma -2 (BCL-2) inhibitor, and duvelisib, an investigational phosphoinositide-3-kinase (PI3K)-delta and PI3K-gamma inhibitor, at the 21^st European Hematology Association (EHA) Annual Congress, June 9-12, in Copenhagen, Denmark. Data will be presented in some of the most common hematological malignancies, including chronic lymphocytic leukemia (CLL), multiple myeloma (MM), acute myeloid leukemia (AML) and follicular lymphoma.

"BCL-2 inhibition is an exciting new mechanism of action and the data that will be presented demonstrate venetoclax's potential across a range of blood cancers," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "The data underscore AbbVie's growing hematology portfolio and our commitment to changing the way blood cancer is treated with innovative new treatment options."

The 10 venetoclax abstracts and one duvelisib abstract that will be presented at EHA demonstrate how AbbVie is utilizing its deep expertise to explore novel mechanisms of action and administration to disrupt cancer development and growth in blood cancers.

AbbVie abstracts:

Venetoclax in CLL

• Impact of adding rituximab to venetoclax on the rate, quality and duration of response in patients with relapsed/refractory chronic lymphocytic leukemia: a cross-study multivariable analysis; Roberts et al.; Abstract P209; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
• Durable treatment-free remission and effective retreatment in patients with relapsed/refractory chronic lymphocytic leukemia who achieved a deep response with venetoclax combined with rituximab; Brander et al.; Abstract P223; Poster Session; June 10, 2016; 5:15-6:45 p.m. CET
• Safety, efficacy and immune effects of venetoclax 400 mg daily in patients with relapsed chronic lymphocytic leukemia; Anderson et al.; Abstract P591; Poster Session; Saturday, June 11, 2016; 5:30-7:00 p.m. CET
• Integrated safety analysis of venetoclax monotherapy in chronic lymphocytic leukemia; Davids et al.; Abstract P225; Poster Session; Friday, June 10 2016; 5:15-6:45 p.m. CET
• Venetoclax is active in CLL patients who have relapsed after or are refractory to ibrutinib or idelalisib; Coutre et al.; Abstract P599; Poster Session; Saturday, June 11 2016; 5:30-7:00 p.m. CET
• Interim quality of life results with venetoclax (ABT-199/GDC-0199) monotherapy in patients with relapsed/refractory del(17p) chronic lymphocytic leukemia; Wierda et al.; Abstract P426; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET

Venetoclax in AML

• Results of a phase 1b study of venetoclax plus decitabine or azacitidine in untreated acute myeloid leukemia patients ?65 years ineligible for standard induction therapy; Pollyea et al.; Abstract P192; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
• Phase 1b/2 study of venetoclax with low-dose cytarabine in treatment-naïve patients aged ?65 years with acute myelogenous leukemia; Lin et al.; Abstract E911; ePOSTER

Venetoclax in MM

• Phase 1b study of venetoclax combined with bortezomib and dexamethasone in relapsed/refractory multiple myeloma; Moreau et al.; Abstract P272; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET
• Phase 1 study of venetoclax monotherapy for relapsed/refractory multiple myeloma; Kumar et al.; Abstract S814; Oral Presentation; Sunday, June 12, 2016; 8:15-8:30 a.m. CET

Duvelisib in Follicular Lymphoma

• Preliminary safety, pharmacokinetics, and pharmacodynamics of duvelisib plus rituximab or obinutuzumab in patients with previously untreated CD20+ follicular lymphoma; Casulo et al.; Abstract P319; Poster Session; Friday, June 10, 2016; 5:15-6:45 p.m. CET

Meeting abstracts are available at www.ehaweb.org.

For more information about CLL, please visit http://abbvieoncology.isebox.net/cll/oncology-content-room.

About Venetoclax

Venetoclax is an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor being evaluated for the treatment of patients with various blood cancer types.^{[1],[2],[3],[4]} The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be over expressed in some cancer types. Venetoclax is designed to selectively inhibit the function of the BCL-2 protein.^[5] 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 chronic lymphocytic leukemia (CLL), along with studies in several other cancers. AbbVie and Genentech will co-promote venetoclax in the U.S.; however, AbbVie has exclusive rights to venetoclax outside of the U.S.

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.^[6] PI3K signaling may lead to the proliferation of malignant B-cells, and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.^{[6],[7] ,[8]} AbbVie and Infinity Pharmaceuticals, Inc. are jointly researching and 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,^[9] a Phase 3 study in combination with other agents in patients with previously treated follicular lymphoma,^[10] and a Phase 3 study in patients with relapsed/refractory chronic lymphocytic leukemia.^[11] Duvelisib is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.

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.

About AbbVie in Oncology

AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers.  We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly two hundred clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

[1] Clinicaltrials.gov. NCT01889186: A study of the efficacy of ABT-199 in subjects with relapsed or refractory chronic lymphocytic leukemia with the 17p deletion. Accessed May 2016.

[2] Clinicaltrials.gov. NCT01994837: A Phase 2 Study of ABT-199 in Subjects With Acute Myelogenous Leukemia (AML). Accessed May 2016.

[3] Clinicaltrials.gov. NCT01794520: Study Evaluating ABT-199 in Subjects with Relapsed or Refractory Multiple Myeloma. Accessed May 2016.

[4] Clinicaltrials.gov. NCT01328626: A Phase 1 Study Evaluating the Safety and Pharmacokinetics of ABT-199 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia and Non-Hodgkin Lymphoma. Accessed May 2016.

[5] Davids, M.S. and Letai, A. ABT-199: A New Hope for Selective BCL-2 Inhibition Cancer Cell. 2013. February 11; 23(2): 139–141.

[6] Winkler DG, Faia KL, DiNitto JP et al.  PI3K-d and PI3K-g inhibition by IPI_145 abrogates immune responses and suppresses activity in autoimmune and inflammatory disease models. Chem Biol 2013;20:1-11.

[7] Reif K et al. Cutting Edge; Differential roles for phosphoinositide 3 kinases, p110-gamma and p110-delta, in lymphocyte chemotaxis and homing. J Immunol 2004:173:2236-2240.

[8] Schmid M et al. Receptor tyrosine kinases and TLR/IL1Rs unexpectedly activate myeloid cell PI3K, a single convergent point promoting tumor inflammation and progression. Cancer Cell 2011;19:715-727.

[9] Clinicaltrials.gov. NCT01882803: A Phase 2 Study of Duvelisib in Subjects With Refractory Indolent Non-Hodgkin Lymphoma (DYNAMO). Accessed May 2016.

[10] Clinicaltrials.gov. NCT02576275: A Phase 3, Randomized, Double-blind Study of Duvelisib Administered in Combination With Rituximab and Bendamustine vs Placebo Administered in Combination With Rituximab and Bendamustine in Subjects With Previously-Treated Indolent Non-Hodgkin Lymphoma. Accessed May 2016.

[11] Clinicaltrials.gov. NCT02004522: A Phase 3 Study of Duvelisib Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (DUO). Accessed May 2016.