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

By Janssen | November 8, 2017

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 59th 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]


Filed Under: Drug Discovery

 

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