Designation granted for inves­ti­ga­tional agent elotuzumab in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies

Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE:BMY) and AbbVie (NYSE:ABBV) to­day an­nounced that the U.S. Food and Drug Admin­istra­tion (FDA) has granted elotuzumab, an inves­ti­ga­tional humanized mono­clonal anti­body, Break­through Therapy Desig­na­tion for use in com­bi­na­tion with lena­lido­mide and dexa­meth­a­sone for the treat­ment of mul­ti­ple myeloma in patients who have re­ceived one or more prior ther­a­pies. The desig­na­tion is based on findings from a ran­dom­ized Phase 2, open-label study that eval­u­ated two dose levels of elotuzumab in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone in pre­vi­ously-treated …

- First Phase III study of dara­tu­mu­mab
- Patient recruitment to start in the coming months

Copenhagen (Press Release) - Genmab A/S (OMX: GEN) announced today that its partner, Janssen Biotech, Inc. ("Janssen") will start a Phase III study of dara­tu­mu­mab in re­lapsed or refractory multiple myeloma.  The study will compare dara­tu­mu­mab in com­bi­na­tion with lena­lido­mide and dexa­metha­sone to lena­lido­mide and dexa­metha­sone alone.

"The dara­tu­mu­mab devel­op­ment pro­gram is progressing very well.  We are extremely pleased to be able to announce that this study eval­u­ating dara­tu­mu­mab in com­bi­na­tion with a core multiple myeloma treat­ment regime will ini­ti­ate patient recruitment in the coming months," said Jan van de Winkel, Ph.D., …

• After initial data read-out in Part 1, study may possibly be expanded and continued in Part 2 for use as a potential registration study
• Patient recruitment expected to start soon

Copenhagen (Press Release) - Genmab A/S (OMX: GEN) announced today that its partner, Janssen Bio­tech, Inc. ("Janssen") will start a new Phase II study of dara­tu­mu­mab in multiple myeloma.  The Phase II study is designed in 2 parts in multiple myeloma patients who have received at least three dif­fer­en­t lines of ther­apy in­­clud­ing both a pro­te­a­some inhibitor and an immuno­modu­la­tory agent (IMiD) or who are double refractory to a pro­te­a­some inhibitor and an IMiD.  This is the same indi­ca­tion for which dara­tu­mu­mab was granted Break­through Therapy Desig­na­tion from the …

Raritan, NJ (Press Release) - Janssen Research & Development, LLC (“Janssen”) announced the si­mul­ta­ne­ous sub­missions of a Biologic License Application (BLA) to the United States Food and Drug Ad­min­is­tra­tion (U.S. FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treat­ment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lym­pho­cytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes.[1,2] This can cause a variety …

Development of novel thera­peutic anti­body ap­proach being eval­u­ated in clin­i­cal trials for patients with multiple myeloma

MorphoSys will hold a conference call on Thursday, June 27, at 4:00pm CEST (3:00pm GMT/10:00am EDT)

• Celgene secures worldwide rights to MOR202, whereby the companies will jointly develop MOR202 globally and co-promote the product in Europe
• MorphoSys retains a 50/50 profit sharing in its co-promotion territory and is eligible to receive tiered double-digit royalties outside of the co-promotion territory

Martinsried and Munich, Germany and Summit, NJ (Press Release) – MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX) and Celgene Corpo­ra­tion (NASDAQ: CELG) today announced an agree­ment to jointly develop MOR202 globally and to co-promote MOR202 in Europe. MOR202 is a fully human mono­clonal anti­body targeting CD38 to treat patients with multiple myeloma (MM) and certain leukemias. MOR202 is cur­rently being eval­u­ated in a phase 1/2a trial in patients with re­lapsed / refractory myeloma. MorphoSys and Celgene will col­lab­o­rate on the devel­op­ment of MOR202 in multiple myeloma and other …

• Median progression-free survival (PFS) of 33 months reached after longer-term follow up in patients treated with elotuzumab 10 mg/kg plus lenalidomide and low-dose dexamethasone
• Longer-term safety profile of the combination consistent with previously reported results
• Results Presented at 18th Annual Congress of the European Hematology Association
• Two Phase 3 studies of elotuzumab at 10 mg/kg dose ongoing in patients with previously-treated and newly-diagnosed multiple myeloma

Princeton, NJ and North Chicago, IL (Press Release) – Bristol-Myers Squibb Com­pany (NYSE: BMY) and AbbVie (NYSE: ABBV) to­day an­nounced up­dated ef­fi­cacy and safety data from a small, ran­dom­ized Phase 2, open-label study in patients with pre­vi­ously-treated mul­ti­ple myeloma that eval­u­ated two doses of the inves­ti­ga­tional mono­clonal anti­body elotuzumab (10 mg/kg and 20 mg/kg) in com­bi­na­tion with lena­lido­mide and low-dose dexa­meth­a­sone. In the 10 mg/kg arm (N=36), which is the dose used in the on­go­ing Phase 3 trials, median pro­gres­sion-free sur­vival (PFS), or the time without dis­ease pro­gres­sion, …

In a recent review article pub­lished in the journal Clinical Cancer Re­search, two myeloma experts from the Dana-Farber Cancer In­sti­tute, Dr. Nikhil Munshi and Dr. Kenneth Anderson, review the latest strategies in the treat­ment of mul­ti­ple myeloma.

In their article, the experts discuss newer ther­a­pies that appear to be promising in clin­i­cal and pre­clin­i­cal stud­ies.

According to the physicians, com­bi­na­tion ther­a­pies that spe­cif­i­cally target a patient’s ge­netic form of the dis­ease will be re­quired for long-term dis­ease con­trol and ultimately a cure.

Some Historical Perspective

In their review article, Drs. Munshi and …