On June 10, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson have reported the latest research to be presented at the 24th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress taking place in Amsterdam, The Netherlands, from 13–16 June 2019 (Press release, Johnson & Johnson, JUN 10, 2019, View Source [SID1234536978]). 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).
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"With more than 11,000 attendees, EHA (Free EHA Whitepaper) 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 (Free EHA Whitepaper) 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 (Free EHA Whitepaper) abstract database here.
Abstract No. Title Date/Time
Daratumumab
Oral Presentations
Abstract #S1451
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
Abstract #S8744
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
Abstract #S8232
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
Abstract #S8755
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
Abstract #PF5986
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
Abstract #PF5927
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
Abstract #PF6038
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
Abstract #PF5919
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
Abstract #PF59610
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
Abstract #PF64111
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
Abstract #PF64312
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
Abstract #PS137713
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
Abstract #PS142514
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
Abstract #PS139515
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
Abstract #S1073
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
Abstract #PF38416
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
Abstract #PF38717
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
Abstract #PF38318
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
Abstract #PF49419
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
Abstract #PF38920
Progression-Free Survival Predicts Overall Survival in Frontline CLL Friday, June 14
5:30 – 7:00 PM CEST
Abstract #PS126421
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 View Source
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.