Janssen Oncology Data to be Presented at 2013 American Society of Hematology
(ASH) Annual Meeting
Findings Highlight Company's Growing Hematologic Area of Focus, Including
Ibrutinib, Siltuximab and Daratumumab
Note: This release corresponds to ASH abstracts 525, 852, 2872, 4163, 505,
1806, 277, 378, 1986
RARITAN, N.J., Nov. 19, 2013
RARITAN, N.J., Nov. 19, 2013 /PRNewswire/ -- Janssen Research & Development,
LLC (Janssen) announced that data related to three Janssen compounds have been
selected for presentation at the 55^th American Society of Hematology (ASH)
Annual Meeting in New Orleans, LA. Nine pieces of company-sponsored research
will be presented out of a total of nearly 50 abstracts involving Janssen
hematology compounds. Data include presentations on the investigational use of
ibrutinib, recently approved by the U.S. Food and Drug Administration;
siltuximab, an investigational anti Interleukin-6 (IL-6) chimeric monoclonal
antibody being studied in multicentric Castleman disease (MCD); and
daratumumab, an investigational human CD38 monoclonal antibody being studied
in multiple myeloma and other B-cell malignancies.
"Therapies for hematologic malignancies are the cornerstone of our broad
oncology portfolio at Janssen R&D," said Peter F. Lebowitz, M.D., Ph.D.,
global oncology therapeutic area head, Janssen. "It's rewarding to have such a
comprehensive array of data presented at ASH, across our oncology compounds,
particularly as we look ahead to potential regulatory milestones for
siltuximab and daratumumab, and following the recent U.S. FDA approval of
List of Company-Sponsored Research to Be Presented
Ibrutinib data will be featured in more than 40 abstracts, including both
company-sponsored research and investigator-initiated studies. The following
studies sponsored by either Janssen or Pharmacyclics, Inc.have been selected
oIbrutinib in combination with bendamustine and rituximab is active and
tolerable in patients with relapsed/refractory CLL/SLL: final results of a
phase 1b study. (Abstract 525)
Oral session: CLL: Therapy, Excluding Transplantation: Chemoimmunotherapy
Clinical Trials. Monday, December 9 at 3:15 pm CST in Ernest N. Morial
Convention Center, 220-222
oCombining ibrutinib with rituximab, cyclophosphamide, doxorubicin,
vincristine, and prednisone (R-CHOP): updated results from a phase 1b
study in treatment-naïve patients with CD20-positive B-cell non-Hodgkin's
lymphoma (NHL). (Abstract 852)
Oral session: Lymphoma: Therapy with Biological Agents, Excluding
Pre-Clinical Models: Aggressive Lymphomas. Tuesday, December 10 at 8:45 am
CST in Ernest N. Morial Convention Center, La Nouvelle Ballroom AB
oChanging the treatment paradigm for previously treated chronic lymphocytic
leukemia patients with del(17p) karyotype. (Abstract 2872)
Poster session: CLL: Therapy, Excluding Transplantation: Poster II.
Sunday, December 8 at 6:30-8:30 pm CST in Ernest N. Morial Convention
Center, Hall E
oThe Bruton's tyrosine kinase (BTK) inhibitor ibrutinib (PCI-32765)
monotherapy demonstrates long-term safety and durability of response in
chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL)
patients in an open-label extension study. (Abstract 4163)
Poster session: CLL: Therapy, Excluding Transplantation: Poster I. Monday,
December 9 at 6:00-8:00 pm CST in Ernest N. Morial Convention Center, Hall
There are a total of three siltuximab abstracts scheduled for presentation at
ASH, including both company-sponsored research and investigator-initiated
studies. The following company-sponsored siltuximab data have been selected
oA multicenter, randomized, double-blind, placebo-controlled study of the
efficacy and safety of siltuximab, an anti-interleukin-6 monoclonal
antibody, in patients with multicentric Castleman's disease. (Abstract
Oral session: Lymphoma: Therapy with Biological Agents, Excluding
Pre-Clinical Models: Immunotherapy for Indolent Lymphomas. Monday,
December 9 at 2:45-4:15 pm CST in Ernest N. Morial Convention Center, La
Nouvelle Ballroom AB
oAn open-label, Phase 2, multicenter study of the safety of long-term
treatment with siltuximab (an anti-interleukin-6 monoclonal antibody) in
patients with multicentric Castleman's disease. (Abstract 1806)
Poster session: Lymphoma: Therapy with Biologic Agents, Excluding
Pre-Clinical Models: Poster I. Saturday, December 7 at 5:30-7:30 pm CST in
Ernest N. Morial Convention Center, Hall G
A total of three daratumumab abstracts have been selected for presentation and
were jointly supported by Janssen and Genmab A/S:
oCD38-Targeted immunochemotherapy of multiple myeloma: preclinical evidence
for its combinatorial use in lenalidomide and bortezomib
refractory/intolerant MM patients. (Abstract 277)
Oral session: Myeloma: Pathophysiology and Pre-Clinical Studies, Excluding
Therapy: Drug Resistance. Monday, December 9 at 7 am CST in Ernest N.
Morial Convention Center, 391-392
oDaratumumab, a novel human anti-CD38 monoclonal antibody, shows anti-tumor
activity in mouse models of MCL, FL and CLL. (Abstract 378)
Oral session: Lymphoma: Pre-Clinical – Chemotherapy and Biologic Agents:
Modulating the Immune System in Lymphoma. Monday, December 9 at 11:45 am
CST in Ernest N. Morial Convention Center, 220-222
oPreliminary safety and efficacy data of daratumumab in combination with
lenalidomide and dexamethasone in relapsed or refractory multiple myeloma.
Poster session: Myeloma: Therapy, Excluding Transplantation: Poster I.
Saturday, December 7 at 5:30-7:30 pm CST in Ernest N. Morial Convention
Center, Hall G
Janssen Biotech, Inc. and Pharmacyclics, Inc. entered a collaboration and
license agreement in December 2011 to jointly develop and commercialize
ibrutinib. On November 13, 2013, the U.S. Food and Drug Administration granted
approval for the use of ibrutinib in patients with mantle cell lymphoma (MCL)
who have received at least one prior therapy. This indication is based on
overall response rate (ORR). An improvement in survival or disease-related
symptoms has not been established.Ibrutinib works by blocking a specific
protein called Bruton's tyrosine kinase (BTK).^1 For more information, visit
www.IMBRUVICA.com. The effectiveness and safety of ibrutinib alone or in
combination with other treatments is being studied in several B-cell
malignancies. Details about the complete ibrutinib clinical program are posted
Siltuximab is an investigational, anti Interleukin-6 (IL-6) chimeric
monoclonal antibody that targets and binds to human IL-6. IL-6 is a
multifunctional cytokine produced by various cells such as T cells, B cells,
monocytes, fibroblasts and endothelial cells.^2 Dysregulated, or imbalanced,
overproduction of IL-6 from activated B cells in affected lymph nodes has been
implicated in the pathogenesis of multicentric Castleman disease (MCD), a rare
blood disorder.^2 Information about ongoing studies with siltuximab can be
found on clinicaltrials.gov.
On September 3, 2013, Janssen announced simultaneous submissions of a Biologic
License Application (BLA) to the United States Food and Drug Administration
(FDA) and a Marketing Authorization Application (MAA) to the European
Medicines Agency (EMA) for siltuximab for the treatment of patients with MCD
who are HIV-negative and HHV-8-negative. Siltuximab has been granted orphan
drug status in MCD in the U.S. and EU.
In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide
license to develop and commercialize daratumumab. Daratumumab is an
investigational human monoclonal antibody (mAb) with broad spectrum cytotoxic
activity. It targets the CD38 molecule, which is highly expressed on the
surface of multiple myeloma cells and may also have potential in other cancers
on which CD38 is expressed. In May 2013, daratumumab was granted Breakthrough
Therapy Designation by the FDA for the treatment of patients with multiple
myeloma who have received at least three prior lines of therapy including a
proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are
double refractory to a PI and IMiD.
About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most
important unmet medical needs of our time in oncology, immunology,
neuroscience, infectious diseases and vaccines, and cardiovascular and
metabolic diseases. Driven by our commitment to patients, we develop
innovative products, services and healthcare solutions to help people
throughout the world. Janssen Research & Development LLC and Janssen Biotech,
Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson.
Please visit http://www.janssenrnd.com for more information.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer is understood,
diagnosed and managed, reinforcing our commitment to the patients who inspire
us. In looking to find innovative ways to address the cancer challenge, our
primary efforts focus on several treatment and prevention solutions. These
include a focus on hematologic malignancies, prostate cancer and lung cancer;
cancer interception with the goal of developing products that interrupt the
carcinogenic process; biomarkers that may help guide targeted, individualized
use of our therapies; as well as safe and effective identification and
treatment of early changes in the tumor microenvironment.
Additional Information about IMBRUVICA
INDICATION – IMBRUVICA is indicated for the treatment of patients with mantle
cell lymphoma (MCL) who have received at least one prior therapy. This
indication is based on overall response rate. An improvement in survival or
disease-related symptoms has not been established.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Hemorrhage – Five percent (5%) of patients with MCL had Grade 3 or higher
bleeding events (subdural hematoma, gastrointestinal bleeding, and hematuria).
Bleeding events including bruising of any grade occurred in 48% of patients
with MCL treated with 560 mg daily. The mechanism for the bleeding events is
not well understood. Consider the benefit-risk of ibrutinib in patients
requiring antiplatelet or anticoagulant therapies and the benefit-risk of
withholding ibrutinib 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. At least 25% of
patients with MCL had infections greater than or equal to Grade 3, according
to NCI Common Terminology Criteria for Adverse Events (CTCAE). Monitor
patients for fever and infections and evaluate promptly.
Myelosuppression – Treatment-emergent Grade 3 or 4 cytopenias were reported in
41% of patients. These included neutropenia (29%), thrombocytopenia (17%) and
anemia (9%). Monitor complete blood counts monthly.
Renal Toxicity – Fatal and serious cases of renal failure have occurred.
Treatment-emergent increases in creatinine levels up to 1.5 times the upper
limit of normal occurred in 67% of patients and from 1.5 to 3 times the upper
limit of normal in 9% of patients. Periodically monitor creatinine levels.
Second Primary Malignancies – Other malignancies (5%) have occurred in
patients with MCL who have been treated with IMBRUVICA, including skin cancers
(4%), and other carcinomas (1%).
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. If this drug is used during
pregnancy or if the patient becomes pregnant while taking this drug, the
patient should be apprised of the potential hazard to a fetus.
Adverse Reactions – The most commonly occurring adverse reactions (greater
than or equal to 20%) in the clinical trial were thrombocytopenia*, diarrhea
(51%), neutropenia*, anemia*, fatigue (41%), musculoskeletal pain(37%),
peripheral edema(35%), upper respiratory tract infection(34%), nausea (31%),
bruising (30%), dyspnea (27%), constipation(25%), rash (25%), abdominal pain
(24%), vomiting( 23%) and decreased appetite (21%).
* Treatment-emergent decreases (all grades) of platelets (57%), neutrophils
(47%) and hemoglobin (41%) were based on laboratory measurements and adverse
The most common Grade 3 or 4 non-hematological adverse reactions (greater than
or equal to 5%) were: pneumonia (7%), abdominal pain (5%), atrial
fibrillation, diarrhea (5%), fatigue (5%), and skin infections (5%).
Treatment-emergent Grade 3 or 4 cytopenias were reported in 41% of patients.
Ten patients (9%) discontinued treatment due to adverse reactions in the trial
The most frequent adverse reaction leading to treatment discontinuation was
subdural hematoma (1.8%). Adverse reactions leading to dose reduction occurred
in 14% of patients.
CYP3A Inhibitors – Avoid concomitant administration with strong or moderate
inhibitors of CYP3A. If a moderate CYP3A inhibitor must be used, reduce the
CYP3A Inducers – Avoid co-administration with strong CYP3A inducers.
Special Populations – Hepatic Impairment – Avoid use in patients with baseline
For the full prescribing information, visit
(This press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995. The reader is cautioned not
to rely on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions prove
inaccurate or unknown risks or uncertainties materialize, actual results could
vary materially from the expectations and projections of Janssen Research &
Development, LLC, any of the other Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited to,
general industry conditions and competition; economic factors, such as
interest rate and currency exchange rate fluctuations; technological advances,
new products and patents attained by competitors; challenges inherent in new
product development, including obtaining regulatory approvals; challenges to
patents; changes in behavior and spending patterns or financial distress of
purchasers of health care products and services; changes to governmental laws
and regulations and domestic and foreign health care reforms; trends toward
health care cost containment; and increased scrutiny of the health care
industry by government agencies. A further list and description of these
risks, uncertainties and other factors can be found in Exhibit 99 of Johnson &
Johnson's Annual Report on Form 10-K for the fiscal year ended December 30,
2012. Copies of this Form 10-K, as well as subsequent filings, are available
online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None
of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertake to
update any forward-looking statements as a result of new information or future
events or developments.)
(1) IMBRUVICA Prescribing Information, November 2013.
(2) El-Osta HE, Kurzrock R. Castleman's disease: from basic mechanisms to
molecular therapeutics. Oncologist. 2011;16(4):497-511.
U.S. Medical Inquiries:
SOURCE Janssen Research & Development, LLC
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