ASH 2017: Janssen to Present 40 Abstracts with New Data on Darzalex, Imbruvica, and Other Compounds from its Portfolio

New data for the immunotherapy DARZALEX (daratumumab) and first-in-class BTK inhibitor IMBRUVICA (ibrutinib) are among eight oral presentations from Janssen Research & Development, LLC, to be featured at the 59^th American Society of Hematology (ASH) Annual Meeting & Exhibition taking place December 9-12, in Atlanta, GA. In total, 40 company-sponsored abstracts for both approved and investigational oncology and cardiovascular compounds have been accepted for presentation. In addition to IMBRUVICA and DARZALEX, data from studies of oral anticoagulant XARELTO^® (rivaroxaban) and investigational compound imetelstat, and more than 20 investigator-initiated studies for all of these compounds, will be presented.

“This year’s ASH meeting promises important updates for approved and investigational compounds across our hematology portfolio,” said Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head of Oncology, Janssen Research & Development. “Data showing long-term outcomes for DARZALEX and IMBRUVICA, as well as initial compelling results for these therapies and new pipeline products, show our strong focus on developing transformational therapies and our unwavering commitment to people living with blood cancers.”

Key company-sponsored data presentations include:

DARZALEX: Early data from the Phase 1b PAVO study will be presented on the tolerability of the subcutaneous delivery of DARZALEX co-formulated with recombinant human hyaluronidase PH20 in patients with relapsed or refractory multiple myeloma. Updated safety, efficacy and pharmacokinetic data for this new investigational delivery method for DARZALEX will be presented at the meeting.
- The Phase 1b data will be presented as an oral presentation at 5:15 p.m. ET on Monday, December 11 (Abstract #838).
DARZALEX: The first look at results from the Phase 2 CENTAURUS trial assessing DARZALEX monotherapy for patients with intermediate or high-risk smoldering multiple myeloma will be presented. Smoldering multiple myeloma is an asymptomatic precursor stage to multiple myeloma, where early intervention to delay or prevent the progression to active disease could benefit patients. These results will serve as the basis of a Phase 3 study, with enrollment initiating later this year.
- The Phase 2 data will be presented as an oral presentation at 5:45 p.m. ET on Sunday, December 10 (Abstract #510).
DARZALEX: Updated analyses from two pivotal trials will be presented. Long-term progression-free survival (PFS) data from the Phase 3 POLLUX trial, which assessed DARZALEX in combination with lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy, will be presented. Additionally, data from the Phase 3 CASTOR clinical trial will provide a first look at overall survival for DARZALEX in combination with bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy.
- The updated POLLUX data will be presented as an oral presentation at 2:45 p.m. ET on Monday, December 11(Abstract #739).
- The updated CASTOR data will be presented as a poster presentation from 5:30 – 7:30 p.m. ET on Saturday, December 9 (Abstract #1852).
IMBRUVICA: A pooled analysis of 3.5-year follow-up data from Phase 2 and Phase 3 studies further supports PFS of the first-in-class BTK inhibitor IMBRUVICA in patients with relapsed or refractory Mantle Cell Lymphoma (MCL).
- The pooled analysis will be presented as an oral presentation at 12:00 p.m. ET on Saturday, December 9(Abstract #151).
IMBRUVICA: Results from a Phase 1/2a study evaluating the safety and efficacy of IMBRUVICA in combination with nivolumab in patients with relapsed or refractory non-Hodgkin lymphoma or chronic lymphocytic leukemia will be presented for the first time.
- The Phase 1/2a data will be presented as an oral presentation at 5:30 p.m. ET on Monday, December 11(Abstract #833).
Imetelstat: Data from the first 32 patients enrolled in Part 1 of an ongoing Phase 2/3 clinical trial of imetelstat in patients with transfusion-dependent anemia due to low or intermediate 1 risk myelodysplastic syndromes (MDS) that is not associated with the deletion 5q cytogenetic abnormality (del[5q]) and who are refractory/resistant to treatment with an erythropoiesis-stimulating agent (ESA) will be presented.
- The Phase 2/3 study will be presented as a poster presentation from 6:00 – 8:00 p.m. ET on Monday, December 11 (Abstract #4256).
Imetelstat: Integrated molecular analysis will identify replicative stress as a sensitizer to imetelstat in Acute Myeloid Leukemia (AML) cells.
- The analysis will be presented as an oral presentation at 5:45 p.m. ET on Monday, December 11 (Abstract #798).
XARELTO: Data will be presented evaluating XARELTO for the treatment of venous thromboembolism (VTE), including economic findings from the EINSTEIN CHOICE study and efficacy and safety results in people with cancer-associated VTE. VTE is the second leading cause of death in people with active cancer.
- EINSTEIN CHOICE data will be presented as an oral presentation at 2:15 p.m. ET on Saturday, December 9(Abstract #218).
- Cancer-associated VTE data will be presented as an oral presentation at 10:30 a.m. ET on Monday, December 11 (Abstract #625).

A full list of company-sponsored abstracts to be presented at the meeting follows below:

Abstract No.	Title			Date/Time
DARZALEX
Oral Presentations
Abstract #510	Daratumumab monotherapy for patients with intermediate or high-risk smoldering multiple myeloma (SMM): CENTAURUS, a randomized, open-label, multicenter Phase 2 Study			Oral Session Sunday, December 10 5:45 p.m. ET
Abstract #838	Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (RRMM): PAVO, an Open-label, Multicenter, Dose Escalation Phase 1b Study			Oral Session Monday, December 11 5:15 p.m. ET
Abstract #739	Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of POLLUX			Oral Session Monday, December 11 2:45 p.m. ET
Poster Presentations
Abstract #1883	Daratumumab, Lenalidomide, and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM) Based on Prior Treatment History, Renal Function, and Cytogenetic Risk: Subgroup Analyses of POLLUX			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1852	Daratumumab, bortezomib, and dexamethasone versus bortezomib and dexamethasone for relapsed/refractory multiple myeloma (RRMM) patients: An update of overall survival in CASTOR			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1828	Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed/Refractory Multiple Myeloma (GEN503): Final Results of an Open-label, Phase 1/2 Study			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1869	Daratumumab in Combination with Carfilzomib and Dexamethasone in Patients (pts) With Relapsed Multiple Myeloma (MMY1001): An Open-label, Phase 1b Study			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #2113	Treatment Patterns and Survival Outcomes in Latin American Patients with Newly Diagnosed Multiple Myeloma: A Retrospective Medical Chart Review Study, 2008-2016			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1879	Interim Safety Analysis of a Phase 2 Randomized Study of Daratumumab (Dara), Lenalidomide (R), Bortezomib (V), and Dexamethasone (d; Dara‐RVd) vs. RVd in Patients (Pts) with Newly Diagnosed Multiple Myeloma (MM) Eligible for High‐Dose Therapy (HDT) and Autologous Stem Cell Transplantation (ASCT)			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1824	Daratumumab in Combination with Pomalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma (RRMM) Patients with ≥2 Prior Lines of Therapy: Updated Analysis of MMY1001			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1839	Results of an Interim Safety Analysis of a Phase 2 Study of Daratumumab (Dara) plus Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Previously Untreated and Relapsed Patients (Pts) with Multiple Myeloma (MM)			Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #3107	Safety and Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed and Refractory Multiple Myeloma: Final Results from GEN501 and SIRIUS			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3100	Daratumumab (DARA) in Combination with Carfilzomib, Lenalidomide, and Dexamethasone (KRd) in Patients with Newly Diagnosed Multiple Myeloma (MMY1001): Updated Results From an Open-label, Phase 1b Study			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3124	Daratumumab in Combination with Lenalidomide Plus Dexamethasone Results in Persistent Natural Killer (NK) Cells with a Distinct Phenotype and Expansion of Effector Memory T-cells in POLLUX, a Phase 3 Randomized Study			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3093	Evaluation of Efficacy Outcomes among Relapsed/ Refractory Multiple Myeloma Treated Patients in a Real-World Setting			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3094	Comparison of Overall Survival Associated with Lenalidomide+Dexamethasone and Bortezomib+Dexamethasone Among Relapsed/Refractory Multiple Myeloma Patients: A Matched Analysis of Real World and Clinical Trial Populations (Facilitation)			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3145	Daratumumab, Bortezomib, and Dexamethasone (DVd) Versus Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of CASTOR			Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #3805	Proteomic profiling reveals targetable pathways in MGUS (SLAMF6, TNFRSF8, TIMP1, TRL2) that may contribute to disease progression			Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
IMBRUVICA
Oral Presentations
Abstract #151		Median 3.5-year Follow-Up of Ibrutinib Treatment in Patients with Relapsed/Refractory Mantle Cell Lymphoma: A Pooled Analysis	Oral Session Saturday, December 9 12:00 p.m. ET
Abstract #833		LYM1002: Phase 1/2A Study of Ibrutinib + Nivolumab Safety and Efficacy of Ibrutinib with Nivolumab Combination in Patients with Relapsed Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia	Oral Session Monday, December 11 5:30 p.m. ET
Poster Presentations
Abstract #2770		Comparative effectiveness of single-agent ibrutinib in the RAY trial versus real-world treatment in the Lyon-Sud database in patients with relapsed or refractory mantle cell lymphoma	Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #2783		FL/MZL: Systematic literature review of the clinical efficacy and safety of treatments in the relapsed/refractory setting for patients with follicular lymphoma or marginal zone lymphoma	Poster Session Sunday, December 10 6:00 – 8:00 p.m.ET
Abstract #4303		A validated risk model for overall survival in relapsed/refractory chronic lymphocytic leukemia applicable to patients treated with novel therapies and standard of care	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Imetelstat
Oral Presentations
Abstract #798		Integrated Molecular Analysis Identifies Replicative Stress as Sensitizer to Imetelstat therapy in AML	Oral Session Monday, December 11 5:45 p.m. ET
Poster Presentations
Abstract #1654		Imetelstat, a Telomerase Inhibitor, Is Capable of Depleting MF Hematopoietic Stem Cells and Progenitor Cells	Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #2860		Telomerase Inhibition Impairs Self-renewal of b- catenin Activated Myeloproliferative Neoplasm Progenitors	Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #4256		Efficacy and Safety of Imetelstat in RBC Transfusion-Dependent (TD) IPSS Low/Int-1 MDS Relapsed/Refractory to Erythropoiesis-Stimulating Agents (ESA) (IMerge)	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
XARELTO
Oral Presentations
Abstract #218		Healthcare Cost Impact of Continued Anticoagulation Therapy with Rivaroxaban versus Aspirin for Prevention of Recurrent Symptomatic Venous Thromboembolism in the EINSTEIN CHOICE Trial Population	Oral Session Saturday, December 9 2:15 p.m. ET
Abstract #625		Anticoagulation Therapy in Cancer Patients at Risk of Recurrence of Venous Thromboembolism: Results of the select-d pilot trial	Oral Session Monday, December 11 10:30 a.m. ET
Poster Presentations
Abstract #2142		Does Treatment Satisfaction Influence Adherence to Treatment? Impact of AF Patients’ Treatment Satisfaction on Adherence to Oral Anticoagulation Treatment	Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1107		The Effect of Rivaroxaban Exposure and Clinical Risk Factors on Efficacy and Safety Outcomes in Patients with Nonvalvular Atrial Fibrillation	Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #1104		The Effects of Rivaroxaban Exposure and of Clinical Risk Factors on Efficacy and Safety Outcomes in Patients Treated for Venous Thromboembolism	Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET
Abstract #2386		A Pooled Analysis of the XALIA and XALIA-LEA Non-Interventional Studies of Rivaroxaban versus Standard Anticoagulation in Venous Thromboembolism	Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #2393		Effectiveness and Safety of Rivaroxaban vs. Warfarin in Patients with Nonvalvular Atrial Fibrillation and Moderate-to-Severe Chronic Kidney Disease	Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET
Abstract #4727		Patient Preferences Regarding Non-Vitamin K Antagonist Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation Patients – a Discrete Choice Experiment	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Abstract #4631		VTE Recurrence and Safety of Anticoagulants Among Patients with Cancer Treated for Venous Thromboembolism	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Abstract #4640		Healthcare Costs Associated with Venous Thromboembolism in Cancer Patients Treated with Anticoagulants	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Abstract #3717		Effectiveness and Safety of Rivaroxaban in Patients with Cancer-Associated Venous Thromboembolism	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Abstract #3718		Effects of Rivaroxaban Exposure and of Clinical Risk Factors on Efficacy and Safety Outcomes in The Prevention of Venous Thromboembolism After Elective Hip or Knee Replacement Surgery	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
Abstract #4726		Real-World Adherence to Non-Vitamin K Antagonist Oral Anticoagulants in Patients with Atrial Fibrillation: Results of an International Survey	Poster Session Monday, December 11 6:00 – 8:00 p.m. ET

About DARZALEX Injection, for Intravenous Infusion

DARZALEX (daratumumab) injection for intravenous use is the first CD38-directed antibody approved anywhere in the world.[1] CD38 is a surface protein that is highly expressed across multiple myeloma cells, regardless of disease stage.[2] DARZALEX is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, including complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), as well as through apoptosis, in which a series of molecular steps in a cell lead to its death.[3] A subset of myeloid derived suppressor cells (MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were decreased by DARZALEX.³ DARZALEX is being evaluated in a comprehensive clinical development program across a range of treatment settings in multiple myeloma, such as in frontline and relapsed settings.[4]^{,[5],[6],[7],[8]}Additional studies are ongoing or planned to assess its potential for a solid tumor indication and in other malignant and pre-malignant diseases in which CD38 is expressed, such as smoldering myeloma.[9]^,[10],[11]DARZALEX was the first CD38-directed antibody to receive regulatory approval to treat relapsed or refractory multiple myeloma.[12]

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that occurs when malignant plasma cells grow uncontrollably in the bone marrow.[13]^,[14] Refractory cancer occurs when a patient’s disease is resistant to treatment or in the case of multiple myeloma, patients progress within 60 days of their last therapy.[15]^,[16]Relapsed cancer means the disease has returned after a period of initial, partial or complete remission.[17] Globally, it is estimated that 124,225 people were diagnosed and 87,084 died from the disease in 2015.[18]^,[19] While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms, which can include bone fracture or pain, low red blood counts, fatigue, calcium elevation, kidney problems or infections.[20]