PHARMACYCLICS, INC. - New data evaluating investigational compound venetoclax as monotherapy and in combination for the treatment of several blood cancers to be presented; AbbVie recently completed submission of NDA for venetoclax to the FDA
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Results from several clinical trials evaluating ibrutinib (IMBRUVICA®) in multiple hematological malignancies accepted for oral presentation
NORTH CHICAGO, Ill., November 5, 2015 - AbbVie (NYSE: ABBV), a leading biopharmaceutical company, will present data from clinical trials evaluating the company's oncology portfolio during the 57th American Society of Hematology Annual Meeting (ASH), December 5-8, in Orlando, Fla. Notably, data scheduled for presentation include results from studies of venetoclax, an investigational oral B-cell lymphoma-2 (BCL-2) inhibitor, in chronic lymphocytic leukemia (CLL) and other hematological malignancies.
Additionally, researchers will present data from studies of ibrutinib (IMBRUVICA®), an inhibitor of Bruton's tyrosine kinase (BTK), as a single-agent and in combination with other therapies in several hematologic malignancies, including CLL, mantle cell lymphoma (MCL), follicular lymphoma (FL), multiple myeloma (MM) and diffuse large B-cell Lymphoma (DLBCL).
"The breadth and depth of the data we are presenting at ASH underscore our commitment to developing treatment options for people affected by blood cancers," said Michael Severino, M.D., executive vice president of research and development and chief scientific officer, AbbVie. "We have made significant progress in advancing our deep and robust pipeline and are excited to share the results of some of our key clinical trials."
Meeting abstracts are available at http://www.hematology.org/Annual-Meeting/Abstracts/.
Select presentations of clinical studies evaluating medicines in AbbVie's oncology pipeline and portfolio include:
Venetoclax Venetoclax (ABT-199 / GDC-0199) Monotherapy in Patients with CLL Refractory to or Relapsed Following Ibrutinib or Idelalisib Therapy; J. Jones et al.; Abstract 715; Oral Session; Monday, December 7, 2015; 2:45-4:15 p.m. EST
Deep and Durable Response Following Venetoclax (ABT-199 / GDC-0199) Combined with Rituximab in Patients with Relapsed/Refractory CLL; S. Ma, et al.; Abstract 830; Oral Session; Monday, December 7, 2015; 4:30-6 p.m. EST
Results of the Safety Run-in Phase of CLL14: Obinutuzumab and Venetoclax (GDC0199/ ABT199) with Obinutuzumab and Chlorambucil in Patients with Previously Untreated CLL and Coexisting Medical Conditions; K. Fischer; Abstract 496; Oral Session; Monday, December 7, 2015; 7-8:30
a.m. EST
Venetoclax (GDC-0199/ABT-199) and Obinutuzumab in Patients with Relapsed/Refractory or Previously Untreated CLL- Results from a Phase 1b Study; I. Flinn et al.; Abstract 494; Oral Session; Monday, December 7, 2015; 7-8:30 a.m. EST
A Phase 1b Study of Venetoclax (ABT-199/GDC-0199) in Combination with Decitabine or Azacitidine in Treatment-Naive Patients with AML; C. DiNardo et al.; Abstract 327; Oral Session; Sunday, December 6, 2015; 4:30-6 p.m. EST
IMBRUVICAResults from the International, Randomized Phase 3 Study of Ibrutinib Versus Chlorambucil in Patients 65 Years and Older with Treatment-Naïve CLL/SLL (RESONATE-2TM); A. Tedeschi et al; Abstract 495; Oral Session; Monday, December 7, 2015; 7:30 a.m. ET
Ibrutinib Plus Bendamustine/Rituximab (BR) is Associated with Greater Reductions in Fatigue than Placebo Plus BR Among Fatigued Chronic Lymphocytic Leukemia Patients Who Are Candidates for Chemotherapy; F. Traina et al.; Abstract 267; Oral Session; Sunday, December 6, 2015; 12:30 p.m. ET
Combination Treatment with the Bruton's Tyrosine Kinase Inhibitor Ibrutinib and Carfilzomib in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma: Initial Results from a Multicenter Phase 1/2b Study; A. Chari et al.; Abstract 377; Oral Session; Sunday, December 6, 2015; 5:30 p.m. ET
Ibrutinib vs Temsirolimus: Results From a Phase 3, International, Randomized, Open-Label, Multicenter Study in Patients With Previously Treated Mantle Cell Lymphoma (MCL); S. Rule et al.; Abstract 469; Oral Session; Monday, December 7, 2015; 7:00 a.m. ET
Ibrutinib Plus Rituximab in Treatment-Naïve Patients with Follicular Lymphoma: Results from a Multicenter, Phase 2 Study; N. Fowler et al.; Abstract 470; Oral Session; Monday, December 7, 2015; 7:15 a.m. ET
Phase I Study of Rituximab, Lenalidomide, and Ibrutinib in Previously Untreated Follicular Lymphoma (Alliance 051103); C. Ujjani et al.; Abstract 471; Oral Session; Monday, December 7, 2015; 7:30 a.m. ET
Phase I Study of Dose-Adjusted-TEDDI-R with Ibrutinib in Untreated and Relapsed/Refractory Primary CNS Lymphoma; K. Dunleavy et al.; Abstract 472; Oral Session; Monday, December 7, 2015; 7:45 a.m. ET
Outcome of Ibrutinib Treatment by Baseline Genetic Features in Patients with Relapsed or Refractory CLL/SLL With del17p in the RESONATE-17 Study; S. Stilgenbauer; Abstract 833; Oral Session; Monday, December 7, 2015; 5:30 p.m. ET
Ibrutinib Responsive MicroRNAs and Upregulation of Tumor Suppressor Targets in Chronic Lymphocytic Leukemia; A. Saleh at al.; Abstract 487; Oral Session; Monday, December 7, 2015; 7
a.m. ET
High Sensitivity Testing Show Multiclonal Mutations in Patients with CLL Treated with BTK Inhibitor and Lack of Mutations in Ibrutinib-Naïve Patients; M. Albitar et al.; Abstract 716; Oral Session; Monday, December 7, 2015; 3 p.m. ET
The Role of PIM1 in the Ibrutinib-Resistant ABC Subtype of Diffuse Large B-Cell Lymphoma; X. Kuo et al.; Abstract 699; Oral Session; Monday, December 7, 2015; 3:15 p.m. ET
DuvelisibPreliminary Results of a Phase Ib Study of Duvelisib in Combination with FCR (dFCR) in Previously Untreated, Younger Patients with CLL; M. Davids et al.; Abstract 4158; Poster Session; Monday, December 7, 2015; 6-8 p.m. EST
Combination Trial of Duvelisib (IPI-145) with Bendamustine, Rituximab, or Bendamustine/Rituximab in Patients with Lymphoma or Chronic Lymphocytic Leukemia; I. Flinn, et al.; Abstract 3928; Poster Session; Monday, December 7, 2015; 6:00-8:00 p.m. EST
Dual Inhibition of PI3K-Delta and Gamma By Duvelisib (IPI-145) Impairs CLL B- and T-Cell Migration, Survival and Proliferation in a Murine Xenograft Model Using Primary Chronic Lymphocytic Leukemia Cells; S. Chen et al.; Abstract 1753; Poster Session; Saturday, December 5, 2015; 5:30-7:30 p.m. EST
Empliciti (Elotuzumab)
Effects of Elotuzumab on Soluble SLAMF7 Levels in Multiple Myeloma; J. Postelnek et al.; Abstract 2964; Poster Session; Sunday, December 6, 2015; 6-8 p.m. EST
ELOQUENT-2 Update: A Phase 3, Randomized, Open-Label Study of Elotuzumab in Combination with Lenalidomide/Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma - 3-
Year Follow-up, M. Dimopoulos et al.; Abstract 28; Oral Session; Saturday, December 5, 2015; 7:30-9 a.m. EST
Elotuzumab Plus Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma; 24-Month Follow-up; A. Palumbo et al.; Abstract 510; Oral Session; Monday, December 7, 2015; 7-9:30 a.m. EST
An Ongoing Multinational Observational Study in Multiple Myeloma (PREAMBLE): Preliminary Report on Patient Survival; G. Cook et al.; Abstract 2093; Poster Session; Saturday, December 5, 2015; 5:30-7:30 p.m. EST
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 (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. 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 earlier phase studies in 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 immunostimulatory antibody targeted against Signaling Lymphocyte Activation Molecule Family 7 (SLAMF7), a cell-surface glycoprotein that is highly expressed on multiple myeloma cells and Natural Killer (NK) cells, but is not detected on normal solid tissue 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 to three 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
Pharmacyclics Inc. issued this content on 2016-01-07 and is solely responsible for the information contained herein. Distributed by Public, unedited and unaltered, on 2016-01-07 20:35:04 UTC
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