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:
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Abstract No. |
Title |
Date/Time |
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DARZALEX |
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Oral Presentations |
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Abstract #510 |
Daratumumab monotherapy for patients with |
Oral Session Sunday, December 10 5:45 p.m. ET
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Abstract #838 |
Subcutaneous Delivery of Daratumumab in Patients |
Oral Session Monday, December 11 5:15 p.m. ET |
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Abstract #739 |
Daratumumab, Lenalidomide, and Dexamethasone |
Oral Session Monday, December 11 2:45 p.m. ET
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Poster Presentations |
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Abstract #1883 |
Daratumumab, Lenalidomide, and Dexamethasone |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1852 |
Daratumumab, bortezomib, and dexamethasone |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1828 |
Daratumumab in Combination with Lenalidomide |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1869 |
Daratumumab in Combination with Carfilzomib and |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #2113 |
Treatment Patterns and Survival Outcomes in Latin |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1879 |
Interim Safety Analysis of a Phase 2 Randomized |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1824 |
Daratumumab in Combination with Pomalidomide |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1839 |
Results of an Interim Safety Analysis of a Phase 2 |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #3107 |
Safety and Efficacy of Daratumumab Monotherapy |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3100 |
Daratumumab (DARA) in Combination with |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3124 |
Daratumumab in Combination with Lenalidomide |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3093 |
Evaluation of Efficacy Outcomes among Relapsed/ |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3094 |
Comparison of Overall Survival Associated with |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3145 |
Daratumumab, Bortezomib, and Dexamethasone |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #3805 |
Proteomic profiling reveals targetable pathways in |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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IMBRUVICA |
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Oral Presentations |
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Abstract #151 |
Median 3.5-year Follow-Up of Ibrutinib Treatment in |
Oral Session Saturday, December 9 12:00 p.m. ET |
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Abstract #833 |
LYM1002: Phase 1/2A Study of Ibrutinib + |
Oral Session Monday, December 11 5:30 p.m. ET
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Poster Presentations |
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Abstract #2770 |
Comparative effectiveness of single-agent ibrutinib |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #2783 |
FL/MZL: Systematic literature review of the clinical |
Poster Session Sunday, December 10 6:00 – 8:00 p.m.ET |
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Abstract #4303 |
A validated risk model for overall survival in |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET
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Imetelstat |
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Oral Presentations |
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Abstract #798 |
Integrated Molecular Analysis Identifies Replicative |
Oral Session Monday, December 11 5:45 p.m. ET |
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Poster Presentations |
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Abstract #1654 |
Imetelstat, a Telomerase Inhibitor, Is Capable of |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #2860 |
Telomerase Inhibition Impairs Self-renewal of b- |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #4256 |
Efficacy and Safety of Imetelstat in RBC |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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XARELTO |
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Oral Presentations |
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Abstract #218 |
Healthcare Cost Impact of Continued |
Oral Session Saturday, December 9 2:15 p.m. ET |
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Abstract #625 |
Anticoagulation Therapy in Cancer Patients at Risk |
Oral Session |
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Poster Presentations |
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Abstract #2142 |
Does Treatment Satisfaction Influence Adherence |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1107 |
The Effect of Rivaroxaban Exposure and Clinical |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #1104 |
The Effects of Rivaroxaban Exposure and of |
Poster Session Saturday, December 9 5:30 – 7:30 p.m. ET |
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Abstract #2386 |
A Pooled Analysis of the XALIA and XALIA-LEA |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #2393 |
Effectiveness and Safety of Rivaroxaban vs. |
Poster Session Sunday, December 10 6:00 – 8:00 p.m. ET |
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Abstract #4727 |
Patient Preferences Regarding Non-Vitamin K |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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Abstract #4631 |
VTE Recurrence and Safety of Anticoagulants |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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Abstract #4640 |
Healthcare Costs Associated with Venous |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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Abstract #3717 |
Effectiveness and Safety of Rivaroxaban in |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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Abstract #3718 |
Effects of Rivaroxaban Exposure and of Clinical |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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Abstract #4726 |
Real-World Adherence to Non-Vitamin K |
Poster Session Monday, December 11 6:00 – 8:00 p.m. ET |
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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
