-
Results from DARZALEX® ▼
(daratumumab) Phase 3 CASSIOPEIA study in newly diagnosed transplant
eligible patients with multiple myeloma selected for the Presidential
Symposium -
Final analysis of Phase 3 IMBRUVICA®▼ (ibrutinib)
RESONATETM-2 study with five-year follow-up
data in previously untreated patients with chronic lymphocytic
leukaemia
BEERSE, Belgium–(BUSINESS WIRE)–The Janssen Pharmaceutical Companies of Johnson & Johnson have announced
the latest research to be presented at the 24th European
Hematology Association (EHA) Annual Congress taking place in Amsterdam,
The Netherlands, from 13–16 June 2019. Janssen will present 28
company-sponsored abstracts from its leading haematological malignancy
portfolio at the congress, including the latest results for DARZALEX®
(daratumumab) and IMBRUVICA® (ibrutinib).
“With more than 11,000 attendees, EHA is the premier congress for the
latest innovations in haematology in Europe and Janssen is proud to be
presenting important data from our clinical development programmes,”
said Dr Patrick Laroche, Europe, Middle East and Africa (EMEA)
Haematology Therapeutic Area Lead, Janssen-Cilag France. “We are
committed to changing outcomes and improving options for patients
diagnosed with cancer. Therefore, we are pleased to present results from
the daratumumab CASSIOPEIA study, which has been selected for inclusion
in the Presidential Symposium. We are also encouraged by the five-year
ibrutinib RESONATETM-2 follow-up findings, which provide
longer-term evidence supporting the efficacy and safety of this BTK
inhibitor in the treatment of chronic lymphocytic leukaemia.”
Highlights of the data to be presented by Janssen include:
First-Time Daratumumab Data in the Treatment of Newly Diagnosed
Patients with Relapsed/Refractory Multiple Myeloma, and its
Investigational Subcutaneous Formulation1,2
Fourteen
daratumumab abstracts have been selected for presentation at the EHA
Annual Congress this year, four of which will be featured in oral
sessions. Notably, results from the Phase 3 CASSIOPEIA study evaluating
daratumumab in combination with bortezomib, thalidomide and
dexamethasone for newly diagnosed patients with multiple myeloma who are
transplant eligible have been selected for presentation as part of the
Presidential Symposium (Abstract
#S145).1 The Presidential Symposium includes the six best
abstracts of the Congress, reflecting ground-breaking research as chosen
by the Scientific Program Committee. These data recently supported
regulatory filings in both the European
Union and the U.S.,
seeking to expand the current indication for daratumumab in the
frontline setting.
Findings from the Phase 3 COLUMBA study will be presented (Abstract
#S823) evaluating a daratumumab subcutaneous formulation in the
treatment of patients with relapsed or refractory multiple myeloma.2
Ibrutinib Long-Term Data in Chronic Lymphocytic Leukaemia3
Results
from the final analysis of the Phase 3 RESONATETM-2 study
(PCYC-1115/1116) study evaluating ibrutinib monotherapy in previously
untreated patients with chronic lymphocytic leukaemia
(CLL) will be presented in an oral session (Abstract
#S107).3 Ibrutinib, a once daily oral BTK inhibitor, is
jointly developed and commercialised by Janssen Biotech, Inc. and
Pharmacyclics LLC, an AbbVie company.3
Select company-sponsored abstracts follow below. Abstracts for
additional Janssen therapies will also be presented and can be found
through the EHA abstract database here.
| Abstract No. | Title | Date/Time | |||
| Daratumumab | |||||
| Oral Presentations | |||||
|
Phase 3 Randomized Study of Daratumumab + Bortezomib/Thalidomide/Dexamethasone (D-VTd) Versus VTd in Transplant-eligible Newly Diagnosed Multiple Myeloma: Part 1 CASSIOPEIA Results |
Presidential Symposium,
Friday, June 14 3:45 – 4:00 PM CEST |
||||
|
Efficacy of Daratumumab, Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma Based Minimal Residual Disease Status: Analysis of CASSIOPEIA |
Saturday, June 15
4:45 – 5:00 PM CEST |
||||
|
Randomized, Open-label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA |
Saturday, June 15
11:30 – 11:45 AM CEST |
||||
|
Subcutaneous Daratumumab, Cyclophosphamide, Bortezomib, and Dexamethasone in Patients with Newly Diagnosed Amyloid Light Chain Amyloidosis: Updated Safety Run-in Results of ANDROMEDA |
Saturday, June 15
5:00 – 5:15 PM CEST |
||||
| Poster Presentations | |||||
|
Stem Cell Yield and Transplantation in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Receiving Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: Phase 3 CASSIOPEIA Study |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Impact of Age on Efficacy and Safety of Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: MAIA |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Faster and Sustained Improvement in Health-related Quality of Life in Transplant-ineligible Newly Diagnosed Multiple Myeloma Patients Treated with Daratumumab, Lenalidomide, and Dexamethasone (D-Rd) Versus Rd: MAIA |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
|
Efficacy and Safety of Daratumumab, Lenalidomide, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of POLLUX Based on Cytogenetic Risk |
Friday, June 14
5:30 – 7:00 PM CEST |
|||
|
Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone in Relapsed or Refractory Multiple Myeloma: Updated Subgroup Analysis of CASTOR Based on Cytogenetic Risk |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Characterization of Treatments and Real-life Outcomes in Patients with Newly Diagnosed Multiple Myeloma Who Received Frontline Autologous Stem Cell Transplantation in Sweden |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Characterization of Frontline Treatment Patterns and the Proportion of Patients Reaching Subsequent Lines of Therapy in Transplant-eligible Patients with Newly Diagnosed Multiple Myeloma |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Improvement in Health-related Quality of Life for Newly Diagnosed Multiple Myeloma Transplant-eligible Patients Treated with Daratumumab, Bortezomib, Thalidomide, and Dexamethasone: CASSIOPEIA |
Saturday, June 15
5:30 – 7:00 PM CEST |
||||
|
Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Europe and Russia with Relapsed or Refractory Multiple Myeloma |
Saturday, June 15
5:30 – 7:00 PM CEST |
||||
|
Comparative Effectiveness of Frontline Treatments for Patients with Newly Diagnosed Multiple Myeloma Who are Transplant-ineligible |
Saturday, June 15
5:30 – 7:00 PM CEST |
||||
| Ibrutinib | |||||
| Oral Presentation | |||||
|
Five Year Follow-Up of Patients Receiving Ibrutinib For First-Line Treatment of Chronic Lymphocytic Leukemia |
Friday, June 14
12:00 – 12:15 PM CEST |
||||
| Poster Presentations | |||||
|
Effectiveness and Safety of Ibrutinib for Chronic Lymphocytic Leukemia (CLL) in Routine Clinical Practice: Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Chronic Lymphocytic Leukemia (CLL) in France |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Prognostic Testing and Treatment Approaches Based on Real-World Clinical Experience from An Interim Analysis of the INFORMCLL Registry of Patients With Chronic Lymphocytic Leukemia [ASH encore] |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
Clinical Outcomes with Single-Agent Ibrutinib for Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL): Interim Analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) Study |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
| Progression-Free Survival Predicts Overall Survival in Frontline CLL |
Friday, June 14
5:30 – 7:00 PM CEST |
||||
|
French Ibrutinib Observational Study (FIRE): Real-World Study of Ibrutinib Treatment for Mantle Cell Lymphoma (MCL) in France |
Saturday, June 15
5:30 – 7:00 PM CEST |
||||
#ENDS#
About daratumumab
Daratumumab is a first-in-class22
biologic targeting CD38, a surface protein that is highly expressed
across multiple myeloma cells, regardless of disease stage.23
Daratumumab is believed to induce tumour 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.24 A subset of myeloid-derived suppressor cells (CD38+
MDSCs), CD38+ regulatory T cells (Tregs) and CD38+ B cells (Bregs) were
decreased by daratumumab.26 Daratumumab is being evaluated in
a comprehensive clinical development programme across a range of
treatment settings in multiple myeloma, such as in frontline and
relapsed settings.25,26,27,28,29,30,31,32 Additional studies
are ongoing or planned to assess its potential in other malignant and
pre-malignant haematologic diseases in which CD38 is expressed, such as
smouldering myeloma.33,34 For more information, please see www.clinicaltrials.gov.
For further information on daratumumab, please see the Summary of
Product Characteristics at https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf.
In August
2012, Janssen Biotech, Inc. and Genmab A/S entered a worldwide
agreement, which granted Janssen an exclusive licence to develop,
manufacture and commercialise daratumumab.35
About ibrutinib
Ibrutinib is a first-in-class Bruton’s
tyrosine kinase (BTK) inhibitor, which works by forming a strong
covalent bond with BTK to block the transmission of cell survival
signals within the malignant B-cells.36 By blocking this BTK
protein, ibrutinib decreases survival and migration of B lymphocytes,
thereby delaying the progression of the cancer.37
Ibrutinib is currently approved in Europe for:38
-
Chronic lymphocytic leukaemia (CLL): As a single agent for the
treatment of adult patients with previously untreated CLL, and as a
single agent or in combination with bendamustine and rituximab (BR)
for the treatment of adult patients with CLL who have received at
least one prior therapy. -
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory
mantle cell lymphoma. -
Waldenström’s macroglobulinemia (WM): Adult patients who have received
at least one prior therapy or in first-line treatment for patients
unsuitable for chemoimmunotherapy.
Ibrutinib is approved in more than 90 countries, and, to date, has been
used to treat more than 140,000 patients worldwide across its approved
indications.
The most common adverse reactions seen with ibrutinib include diarrhoea,
neutropenia, haemorrhage (e.g. bruising), musculoskeletal pain, nausea,
rash, and pyrexia.38
For a full list of side effects and information on dosage and
administration, contraindications and other precautions when using
ibrutinib please refer to the Summary
of Product Characteristics for further information.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At
Janssen, we’re creating a future where disease is a thing of the past.
We’re the Pharmaceutical Companies of Johnson & Johnson, working
tirelessly to make that future a reality for patients everywhere by
fighting sickness with science, improving access with ingenuity, and
healing hopelessness with heart. We focus on areas of medicine where we
can make the biggest difference: Cardiovascular & Metabolism,
Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and
Pulmonary Hypertension.
Learn more at www.janssen.com/emea.
Follow us at www.twitter.com/janssenEMEA
for our latest news. Janssen Biotech, Inc., Janssen-Cilag International
NV, and Janssen-Cilag France Limited are part of the Janssen
Pharmaceutical Companies of Johnson & Johnson.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined
in the Private Securities Litigation Reform Act of 1995 regarding
daratumumab and ibrutinib. 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 known or unknown risks or uncertainties materialise,
actual results could vary materially from the expectations and
projections of Janssen Research & Development, LLC., Janssen-Cilag
France and any of the other Janssen Pharmaceutical Companies and/or
Johnson & Johnson. Risks and uncertainties include, but are not limited
to: challenges and uncertainties inherent in product research and
development, including the uncertainty of clinical success and of
obtaining regulatory approvals; uncertainty of commercial success;
manufacturing difficulties and delays; competition, including
technological advances, new products and patents attained by
competitors; challenges to patents; [product efficacy or safety concerns
resulting in product recalls or regulatory action;] changes in behaviour
and spending patterns of purchasers of health care products and
services; changes to applicable laws and regulations, including global
health care reforms; and trends toward health care cost containment. A
further list and descriptions of these risks, uncertainties and other
factors can be found in Johnson & Johnson’s Annual Report on Form 10-K
for the fiscal year ended December 30, 2018, including in the sections
captioned “Cautionary Note Regarding Forward-Looking Statements” and
“Item 1A. Risk Factors,” and in the company’s most recently filed
Quarterly Report on Form 10-Q, and the company’s subsequent filings with
the Securities and Exchange Commission. Copies of these 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 undertakes to update any forward-looking
statement as a result of new information or future events or
developments.
References
|
1 Moreau P, Attal M, Hulin C, et al. Phase 3 randomized study of daratumumab + bortezomib/thalidomide/dexamethasone (D-VTD) in transplant-eligible newly diagnosed multiple myeloma: part 1 CASSIOPEIA results. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract S145. |
|
2 Mateos MV, Nahi H, Legiec W, et al. Randomized, open-label, non-inferiority Phase 3 study of subcutaneous (sc) versus intravenous (iv) daratumumab (DARA) administration in patients with relapsed or refractory multiple myeloma: COLUMBA. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract S823. |
|
3 Tedeschi A, Burger J, Barr PM, et al. Five-year follow of patients receiving ibrutinib for first-line treatment of chronic ltmphocytic leukemia. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract S107. |
|
4 Avet-Loiseau H, Moreau P, van der Velden VH, et al. Efficacy of daratumumab + bortezomib/thalidomide/dexamethasone (D-VTD) in transplant-eligible newly diagnosed multiple myeloma based on minimal residual disease status: analysis of CASSIOPEIA. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract S874. |
|
5 Comenzo RL, Kastritis E, Maurer M, et al. Subcutaneous daratumumab + cyclophosphamide, bortezomib, and dexamethasone (CyBorD) in patients with newly diagnosed amyloid light chain (AL) amyloidosis: updated safety run-in results of ANDROMEDA. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract S875. |
|
6 Hulin C, Moreau P, Attal M, et al. Stem cell yield and transplantation in transplant-eligible newly diagnosed multiple myeloma patients receiving daratumumab + bortezomib/thalidomide/dexamethasone (D-VTD): phase 3 CASSIOPEIA study. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF598. |
|
7 Hulin C, Facon T, Kumar S, et al. Impact of age on efficacy and safety of daratumumab in combination with lenalidomide and dexamethasone (D-RD) in patients with transplant-ineligible newly diagnosed multiple myeloma (NDMM): MAIA. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF592. |
|
8 Perrot A, Facon T, Plesner T, et al. Faster & sustained improvement in health-related quality of life in transplant-ineligible newly diagnosed multiple myeloma patients treated with daratumumab, lenalidomide, and dexamethasone (D-Rd) versus Rd: MAIA. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF603. |
|
9 Dimopoulos MA, San-Miguel J, White D, et al. Efficacy and safety of daratumumab, lenalidomide, and dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): updated subgroup analysis of POLLUX based on cytogenetic risk. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF591. |
|
10 Weisel K, Spencer A, Lentzsch S, et al. Efficacy and safety of daratumumab, bortezomib, and dexamethasone (D-Vd) in relapsed or refractory multiple myeloma (RRMM): updated subgroup analysis of CASTOR based on cytogenetic risk. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF596. |
|
11 Schain F, Cote S, Lam A, et al. Characterization of treatments and real-life outcomes in patients with newly diagnosed multiple myeloma who received frontline autologous stem cell transplantation in Sweden. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF641. |
|
12 Voorhees PM, Fonseca R, Cote S, et al. Characterization of frontline treatment patterns and the proportion of patients reaching subsequent lines of therapy in transplant-eligible patients with newly diagnosed multiple myeloma. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF643. |
|
13 Roussel M, Moreau P, Attal M, et al. Improvement in health-related quality of life for newly diagnosed multiple myeloma transplant-eligible patients treated with daratumumab, bortezomib, thalidomide, and dexamethasone: CASSIOPEIA study. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PS1377. |
|
14 Cook G, Corso A, Streetly M, et al. Results of the daratumumab monotherapy early access treatment protocol (EAP) in patients from Europe and Russia with relapsed or refractory multiple myeloma. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PS1425. |
|
15 Facon T, et al. Comparative effectiveness of frontline treatments for patients with newly diagnosed multiple myeloma who are transplant-ineligible. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PS1395. |
|
16 Janssens A, Andre M, Berneman Z, et al. Effectiveness and safety of Ibrutinib for chronic lymphocytic leukemia (CLL) in routine clinical practice: interim analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) study. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF384. |
|
17 Dartigeas C, et al. French Ibrutinib Observational Study (FIRE): real-world study of ibrutinib treatment for chronic lymphocytic leukemia (CLL) in France. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF387. |
|
18 Mato AR, Barrientos JC, Brander D, et al. Prognostic testing and treatment approaches based on real-world clinical experience from an interim analysis of the INFORMCLL registry of patients with chronic lymphocytic leukemia. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF383. |
|
19 Janssens A, Berneman Z, Bron D, et al. Clinical outcomes with single-agent ibrutinib for relapsed/refractory (R/R) mantle cell lymphoma (MCL): interim analysis (IA) of the Belgian Ibrutinib Real-World Data (BIRD) study. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF494. |
|
20 Baculea S, Horsburgh S, Chadda S, et al. Progression-free survival predicts overall survival in frontline CLL. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PF389. |
|
21 Slama R, Delmer A, Cartron G, et al. French Ibrutinib Observational Study (FIRE): real-world study of ibrutinib treatment for mantle cell lymphoma (MCL) in France. Presented at 24th Annual Congress of the European Hematology Association (EHA), Amsterdam, Netherlands, 13-16 June 2019: abstract PS1264. |
|
22 Sanchez L, Wang Y, Siegel DS, Wang ML. Daratumumab: a first-in-class CD38 monoclonal antibody for the treatment of multiple myeloma. J Hematol Oncol. 2016;9:51. |
|
23 Fedele G, Di Girolamo M, Recine U, et al. CD38 ligation in peripheral blood mononuclear cells of myeloma patients induces release of protumorigenic IL-6 and impaired secretion of IFNγ cytokines and proliferation. Mediators Inflamm. 2013;2013:564687. |
|
24 European Medicines Agency. DARZALEX summary of
https://www.ema.europa.eu/documents/product-information/darzalex-epar-product-information_en.pdf |
|
25 ClinicalTrials.gov. A study to evaluate daratumumab |
|
26 ClinicalTrials.gov. A study comparing daratumumab, |
|
27 ClinicalTrials.gov. Addition of daratumumab to |
|
28 ClinicalTrials.gov. A study of combination of |
|
29 ClinicalTrials.gov. Study comparing daratumumab, |
|
30 ClinicalTrials.gov. A study of Velcade (bortezomib) |
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31 ClinicalTrials.gov. Comparison of pomalidomide and |
|
32 ClinicalTrials.gov. Study of carfilzomib, |
|
33 ClinicalTrials.gov. A study to evaluate 3 dose |
|
34 ClinicalTrials.gov. An efficacy and safety proof of |
|
35 Johnson & Johnson. Janssen Biotech announces global |
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36 O’Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol. 2014;15:48-58. |
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37 European Medicines Agency. Imbruvica (ibrutinib): an |
|
38 Imbruvica Summary of Product Characteristics, May |
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