RARITAN, N.J., Nov. 5, 2015 /PRNewswire/ -- At the 57thAmerican Society of Hematology (ASH) Annual Meeting, Janssen Research & Development, LLC will present new data for both approved and investigational oncology and cardiovascular compounds across 10 disease areas. More than 40 abstracts from company-sponsored studies have been accepted for presentation, including 17 oral presentations, the largest presence of company data to date. Oral presentations from five Janssen brands across two therapeutic areas will be presented at the meeting, including ibrutinib, daratumumab, siltuximab, imetelstat and rivaroxaban. Data and posters from bortezomib, decitabine and JNJ56022473 (formerly CSL362) will be presented as well.
"The depth and breadth of data presented at ASH 2015 demonstrate our deep passion for developing transformational medical solutions to treat and prevent disease in novel ways, with the goal of radically improving health for patients in need," said William N. Hait, M.D., Ph.D., Global Head, Janssen Research & Development, LLC.
- Ibrutinib will be featured in 23 presentations sponsored by either Janssen or its collaboration partner, Pharmacyclics, seven of which are orals. Presentations include data evaluating its use as a single agent and in combination with other therapies across several disease states. IMBRUVICA is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.
- Daratumumab will be featured in 10 presentations sponsored or supported by Janssen, three of which are orals. The company will present data evaluating the fully human anti-CD38 monoclonal antibody as a single agent and in combination with standard therapies in multiple myeloma patients who are relapsed or refractory to standard therapies.
- Siltuximab will be featured in one presentation sponsored by Janssen, reporting data from a Phase 2 study assessing the economic burden of relapsed or refractory multiple myeloma.
- Imetelstat will be featured in two oral presentations sponsored by either Janssen or its licensing and collaboration partner, Geron Corporation.
- Rivaroxaban will be featured in four oral presentations on anticoagulant use in venous thromboembolic disease sponsored by Janssen Pharmaceuticals, Inc. and its development partner for this medicine, Bayer HealthCare.
Ibrutinib Oral Presentations:
Chronic Lymphocytic Leukemia
- Results from the International, Randomized Phase 3 Study of Ibrutinib Versus Chlorambucil in Patients 65 Years and Older with Treatment-Naive CLL/SLL (RESONATE-2). (Abstract 495)
- Outcome of Ibrutinib Treatment by Baseline Genetic Features in Patients with Relapsed or Refractory CLL/SLL With del17p in the RESONATE-17 Study. (Abstract 833)
- Ibrutinib Plus Bendamustine/Rituximab (BR) is Associated with Greater Reductions in Fatigue Than Placebo Plus BR Among Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia and Fatigue. (Abstract 267)
Mantle Cell Lymphoma
- Ibrutinib vs Temsirolimus: Results From a Phase 3, International, Randomized, Open-Label, Multicenter Study in Patients With Previously Treated Mantle Cell Lymphoma (MCL). (Abstract 469)
Multiple Myeloma
- 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. (Abstract 377)
Diffuse Large B-cell Lymphoma
- The Role of PIM1 in Ibrutinib-Resistant ABC Subtype of Diffuse Large B-cell Lymphoma. (Abstract 699)
Follicular Lymphoma
- Ibrutinib Plus Rituximab in Treatment-Naive Patients with Follicular Lymphoma: Results from a Multicenter, Phase 2 Study. (Abstract 470)
Daratumumab Oral Presentations:
Multiple Myeloma
- Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma. (Abstract 29)
- Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results of a Phase 1/2 Study (GEN503). (Abstract 507)
- Open-label, Multicenter, Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with at Least 2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma. (Abstract 508)
Siltuximab Oral Presentation:
Multiple Myeloma
- Economic Burden of Relapsed or Refractory Multiple Myeloma: Results from an International Trial. (Abstract 875)
Imetelstat Oral Presentations:
- Telomerase Inhibitor Imetelstat Therapy in Refractory Anemia with Ring Sideroblasts with or without Thrombocytosis. (Abstract 55)
- Dynamics of Mutations in Patients with ET Treated with Imetelstat. (Abstract 57)
Rivaroxaban Oral Presentations:
Deep Vein Thrombosis and Pulmonary Embolism
- Safe and Effective Use of Rivaroxaban for Treatment of Cancer-Associated Venous Thromboembolic Disease: A Quality Improvement Initiative. (Abstract 431)
- Current Practice Patterns and Patient Persistence on Anticoagulant Treatments for Cancer-Associated Thrombosis. (Abstract 626)
- Xalia, a Non-Interventional Study Comparing Rivaroxaban with Standard Anticoagulation for Initial and Long-Term Therapy in Deep Vein Thrombosis. (Abstract 894)
- Validation of the Inhospital Mortality for Pulmonary Embolism Using Claims Data (IMPACT) Prediction Rule within an All-Payer Inpatient Administrative Claims Database. (Abstract 747)
About IMBRUVICA® (ibrutinib)
IMBRUVICA was one of the first therapies to receive U.S. approval after having received the FDA's Breakthrough Therapy Designation. IMBRUVICA works by blocking a specific protein called Bruton's tyrosine kinase (BTK).1 The BTK protein transmits important signals that tell B cells to mature and produce antibodies and is needed by specific cancer cells to multiply and spread.1,2 IMBRUVICA targets and blocks BTK, inhibiting cancer cell survival and spread.1 For more information, visit www.IMBRUVICA.com.
Additional Information about IMBRUVICA®
INDICATIONS
IMBRUVICA® is indicated to treat people with:
- Chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
- Chronic lymphocytic leukemia (CLL) with 17p deletion
- Waldenstrom's macroglobulinemia (WM)
- Mantle cell lymphoma (MCL) who have received at least one prior therapy
- Accelerated approval was granted for this indication based on overall response rate. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage - Fatal bleeding events have occurred in patients treated with IMBRUVICA®. Grade 3 or higher bleeding events (subdural hematoma, gastrointestinal bleeding, hematuria, and post-procedural hemorrhage) have occurred in up to 6% of patients. Bleeding events of any grade, including bruising and petechiae, occurred in approximately half of patients treated with IMBRUVICA®.
The mechanism for the bleeding events is not well understood. IMBRUVICA® may increase the risk of hemorrhage in patients receiving antiplatelet or anticoagulant therapies. Consider the benefit-risk of withholding IMBRUVICA® for at least 3 to 7 days pre and post-surgery depending upon the type of surgery and the risk of bleeding.
Infections - Fatal and non-fatal infections have occurred with IMBRUVICA® therapy. Grade 3 or greater infections occurred in 14% to 26% of patients. Cases of progressive multifocal leukoencephalopathy (PML) have occurred in patients treated with IMBRUVICA®. Monitor patients for fever and infections and evaluate promptly.
Cytopenias - Treatment-emergent Grade 3 or 4 cytopenias including neutropenia (range, 19 to 29%), thrombocytopenia (range, 5 to 17%), and anemia (range, 0 to 9%) occurred in patients treated with IMBRUVICA®. Monitor complete blood counts monthly.
Atrial Fibrillation - Atrial fibrillation and atrial flutter (range, 6 to 9%) have occurred in patients treated with IMBRUVICA®, particularly in patients with cardiac risk factors, acute infections, and a previous history of atrial fibrillation. Periodically monitor patients clinically for atrial fibrillation. Patients who develop arrhythmic symptoms (e.g., palpitations, lightheadedness) or new-onset dyspnea should have an ECG performed. If atrial fibrillation persists, consider the risks and benefits of IMBRUVICA® treatment and dose modification.
Second Primary Malignancies - Other malignancies (range, 5 to 14%) including non-skin carcinomas (range, 1 to 3%) have occurred in patients treated with IMBRUVICA®. The most frequent second primary malignancy was non-melanoma skin cancer (range, 4 to 11%).
Tumor Lysis Syndrome - Tumor lysis syndrome has been reported with IMBRUVICA® therapy. Monitor patients closely and take appropriate precautions in patients at risk for tumor lysis syndrome (e.g., high tumor burden).
Embryo-Fetal Toxicity - Based on findings in animals, IMBRUVICA® can cause fetal harm when administered to a pregnant woman. Advise women to avoid becoming pregnant while taking IMBRUVICA®.
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