- Randomized comparison of ibrutinib versus ofatumumab in previously treated
chronic lymphocytic leukemia/small lymphocytic lymphoma: results from the phase III
RESONATE (TM) trial. Oral session: Presidential Symposium. Saturday 14 June 2014,
14:45-15:00 CEST in Room Gold (SW- Level 2) Lead Author: Peter Hillmen, MBChB, PhD,
St. James University Hospital, Leeds, United Kingdom
- Phase 2 study of ibrutinib in relapsed or refractory mantle cell lymphoma:
Updated safety analysis on prevalence of infection, diarrhea, and bleeding over time.
(Abstract P461) Poster presentation session: Aggressive Non-Hodgkin lymphoma -
Clinical 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level
0) Lead Author: Simon Rule, M.D., Department of Haematology, Derriford Hospital,
Plymouth, United Kingdom
Daratumumab
Four daratumumab abstracts have been accepted for presentation and were jointly sponsored by Janssen and Genmab A/S. Janssen licensed daratumumab from Genmab A/S in 2012 and is working with the company to fully transition the development programme to Janssen. The selected daratumumab abstracts at EHA include:
- Dose-dependent efficacy of daratumumab (DARA) as monotherapy in patients
with relapsed or refractory multiple myeloma (RR MM). (Abstract P356) Poster
presentation session: Myeloma and other monoclonal gammopathies - Clinical 1 (Poster).
Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Henk
Lokhorst, M.D., Ph.D., UMC Utrecht, Utrecht, Netherlands, Utrecht, Netherlands
- Safety and efficacy of daratumumab with lenalidomide and dexamethasone in
relapsed or relapsed, refractory multiple myeloma. (Abstract P350) Poster presentation
session: Myeloma and other monoclonal gammopathies - Clinical 1 (Poster). Friday 13
June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead Author: Torben Plesner,
M.D., Vejle Hospital, Vejle, Denmark
- Daratumumab treatment in combination with CHOP or R-CHOP results in the
inhibition or regression of tumours in preclinical models of non-Hodgkins lymphoma.
(Abstract P434) Poster presentation session: Non-Hodgkin & Hodgkin lymphoma - Biology
1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in Poster Area (NW - Level 0) Lead
Author: Parul Doshi, M.D., Oncology Translational Medicine and Early Development.
- Daratumumab treatment alone or in combination with vincristine results in the
inhibition of tumor growth and long term survival in preclinical models of acute
lymphocytic leukemia. (Abstract P109) Poster presentation session: Acute lymphoblastic
leukemia - Biology 1 (Poster). Friday 13 June 2014, 17:45-19:00 CEST in e-Poster Area
(NW - Level 0) Lead Author: Parul Doshi, M.D., Oncology Translational Medicine and
Early Development.
About VELCADE(R) (bortezomib)[1] VELCADE (bortezomib) is a medicine used to treat the blood-based cancer known as multiple myeloma. It contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die.
VELCADE is the market leader in the treatment of frontline non-transplant eligible multiple myeloma. It is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium is responsible for commercialisation of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 550,000 patients worldwide.
About siltuximab Siltuximab is an anti-interleukin-6 (IL-6) chimeric monoclonal antibody that 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. Dysregulated overproduction of IL-6 from activated B cells in affected lymph nodes has been implicated in the pathogenesis of, or mechanism causing, MCD.[2] Information about ongoing studies with siltuximab can be found at http://www.clinicaltrials.gov.
On September 3, 2013 [http://www.investor.jnj.com/releasedetai... ], Janssen Research & Development, LLC announced simultaneous submissions of a Biologic License Application (BLA) to the U.S. FDA and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with MCD who are HIV negative or HHV-8 negative. The EMA has granted Acceleration Assessment of the MAA. On March 20, 2014 [http://www.ema.europa.eu/docs/en_GB/docu... ] , the Committee for Medicinal Products for Human Use (CHMP) of the EMA adopted a positive opinion recommending the marketing authorization of siltuximab for the treatment of adult patients with MCD who are HIV negative or HHV-8 negative. The U.S. Food and Drug Administration's approval of SYLVANT(TM) was announced on April 23, 2014 [http://www.jnj.com/news/all/SYLVANT-siltuximab-Receives-FDA-... ] . Siltuximab has been granted orphan drug status in MCD in the U.S. and European Union.
About Ibrutinib Ibrutinib is an investigational compound within a class of medicines called Bruton's tyrosine kinase (BTK) inhibitors. BTK is an important protein involved in mediating the cellular signalling pathways which control B cell maturation and survival. In malignant B cells, there is excessive signalling through the B cell receptor (BCR) and other signalling pathways, which includes BTK. The malignant cell ignores the natural signal to die and continues to develop and proliferate. Malignant cells migrate and adhere to protective environmental areas such as the lymph nodes where they proliferate and survive. Ibrutinib is specifically designed to target and inhibit BTK. Ibrutinib forms a strong covalent bond with BTK, which inhibits the excessive transmission of cell survival signals within the malignant B cells and stops their excessive build up in these protected environmental areas. The efficacy and safety of ibrutinib alone and in combination with other treatments is being studied in several blood cancers including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia (WM), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL) and multiple myeloma (MM).[3-7]
On October 30, 2013 [http://www.investor.jnj.com/releasedetai... ], Janssen-Cilag International NV submitted a New Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for ibrutinib for the treatment of adult patients with relapsed or refractory CLL/small lymphocytic lymphoma (SLL) or relapsed or refractory MCL.
Ibrutinib is marketed as IMBRUVICA(R) in the U.S., where it received approval on November 13, 2013 [http://www.fda.gov/drugs/informationondr... ] from the U.S. Food and Drug Administration (FDA) for the treatment of patients with MCL who have received at least one prior therapy, followed by further indication approval on February 12, 2014 [http://www.fda.gov/newsevents/newsroom/p... ] for the treatment of patients with CLL who have received at least one prior therapy.
About Daratumumab
(CONTINUA)
