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Genmab and Janssen Sign License Agreement For Dara­tu­mu­mab For Multiple Myeloma – Danish bio­technology com­pany Genmab has signed a license agree­ment with Janssen Biotech Inc., a sub­sid­i­ary of Johnson & Johnson, allow­ing Janssen to further develop and mar­ket daratumumab for the treat­ment of multiple myeloma. Dara­tu­mu­mab belongs to the same class of drugs as elotuzumab and siltuximab, called mono­clonal anti­bodies. Monoclonal anti­bodies signal the body's immune sys­tem to kill myeloma cells. Dara­tu­mu­mab recently showed promising activity in re­lapsed and refractory myeloma patients (see related Beacon news). It is cur­rently being studied in Phase 1/2 trials, which will be com­pleted by Genmab. According to the agree­ment, which could be worth more than $1 billion, Janssen will com­plete all addi­tional devel­op­ment of dara­tu­mu­mab. For more in­for­ma­tion, please see the Johnson & Johnson press release.

Phase 1/2 Clinical Trial To Study Linsitinib In Relapsed And Refractory Myeloma Patients – The University Health Network of Toronto, in col­lab­o­ration with the Multiple Myeloma Research Consortium and Japanese pharma­ceu­tical com­pany Astellas Pharma, is starting a Phase 1/2 trial of linsitinib in com­bi­na­tion with Velcade (bor­tez­o­mib) and dexamethasone (Decadron) in re­lapsed and refractory multiple myeloma patients. The trial, which will take place at the Princess Margaret Hospital in Toronto, is avail­able to myeloma patients who have received at least one prior ther­apy. Linsitinib (ASP7487, OSI-906) is a protein that triggers cancer cell death by inhibiting insulin-like growth factor 1. Preclinical studies have shown linsitinib to be effective when given with Velcade. For more in­for­ma­tion, please see the clinical trial description.

Revlimid-Delanzomib-Dexamethasone Combination May Be Effective For Multiple Myeloma – Results from a pre­clin­i­cal study indicate that delanzomib (CEP-18770) in com­bi­na­tion with Revlimid (lena­lido­mide) and dexa­meth­a­sone may be an effective treat­ment for multiple myeloma. Specifically, researchers found that the three-drug com­bi­na­tion limited cancer growth more than Revlimid-dexamethasone ther­apy alone. Delanzomib, like Velcade and Kyprolis (car­filz­o­mib), is a pro­te­a­some inhibitor that prevents the breakdown of proteins in cancer cells, triggering their death. The results of the current study sup­port pre­vi­ous pre­clin­i­cal findings that showed delanzomib is a viable alter­na­tive for patients who do not respond to Velcade. Based on their findings the study investigators rec­om­mend addi­tional study of this three-drug ther­apy. For more in­for­ma­tion, please see the study in Leukemia Research.

HIV/AIDS Drug Zidovudine May Be Effective For Multiple Myeloma – Findings from a recent Brazilian study show that the HIV/AIDS drug zidovudine (Retrovir, also known generically as azidothymidine, or AZT) may be an effective treat­ment for multiple myeloma. Zidovudine was the first ther­apy in the United States approved for the treat­ment of HIV.  In the current study, researchers showed that zidovudine triggers cancer cell death in human myeloma cell lines. The study investigators also reported that zidovudine sig­nif­i­cantly reduced the number of myeloma cells in mice. According to the Brazilian researchers, this is the first time zidovudine has been studied in the context of multiple myeloma, and they suggest that the drug be in­ves­ti­gated further for the treat­ment of multiple myeloma. For more in­for­ma­tion, please refer to the study in Anticancer Agents in Medical Chemistry (abstract).

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Interim results of an ongoing early-stage clin­i­cal trial indicate that dara­tu­mu­mab is safe as a treat­ment for re­lapsed and refractory multiple myeloma. In addi­tion, dara­tu­mu­mab showed promising activity in the trial par­tic­i­pants.

Dr. Torben Plesner of Vejle Hospital in Denmark presented the pre­lim­i­nary results of the Phase 1/2 study at the 48th annual meeting of the American Society of Clinical Oncology (ASCO) on Monday.

“The efficacy [of dara­tu­mu­mab] looks very promising,” said Dr. Andrzej Jakubowiak, the director of the myeloma pro­gram at the University of Chicago, who was not involved in the …

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Today is the fourth day of the American Society of Clinical Oncology (ASCO) 2012 annual meeting, and the meeting con­tinued to be filled with in­ter­est­ing re­­sults from clin­i­cal trials in mul­ti­ple myeloma patients.

The day in­cluded a session of oral pre­sen­ta­tions in the late morn­ing that featured re­­sults from three clin­i­cal trials involving immuno­therapy agents.

The three com­pounds, elotuzumab, siltuximab, and daratumumab, belong to the class of drugs called mono­clonal anti­bodies. They work by identifying pro­teins on the surface of myeloma cells and signal for the im­mune sys­tem to …

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[ by Maike Haehle | May 23, 2012 12:20 pm | 20 Comments ]

During the upcoming annual meeting of the American Society of Clinical Oncology (ASCO), results will be presented from clin­i­cal trials involving poten­tial new drugs under devel­op­ment for the treat­ment of multiple myeloma.

In particular, results for newer, lesser known agents that are in the early stages of clin­i­cal devel­op­ment will take center stage. These agents in­clude obatoclax, siltuximab, daratumumab, and SNS01-T.

According to the recently released ASCO abstracts, the agents showed varying degrees of activity in re­lapsed and refractory myeloma patients. So it will be particularly in­ter­est­ing to …

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The 48th annual meeting of the American Society of Clinical Oncology (ASCO) will take place Friday, June 1, through Tuesday, June 5, in Chicago.

More than 25,000 clin­i­cal spe­cialists from all over the world are ex­pec­ted to attend the five-day meeting to discuss the cur­rent re­search in cancer treat­ment and care. The theme for this year’s meeting is “Collaborating to Conquer Cancer.”

The meeting will in­clude many pre­sen­ta­tions and seminars focused spe­cif­i­cally on mul­ti­ple myeloma. The ASCO website cur­rently lists nearly 50 myeloma-based pre­sen­ta­tions (included under “lymphoma and plasma cell disorders”).

The …

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Celgene Seeks Expanded Approval For Revlimid In Europe – The pharma­ceu­tical com­pany Celgene announced on Tuesday that it is seeking expanded approval for Revlimid (lena­lido­mide) as treatment for multiple myeloma in Europe. The European Medicines Agency (EMA) will review approval of Revlimid for main­te­nance ther­apy of newly diag­nosed myeloma patients who have not progressed after initial ther­apy with melphalan (Alkeran), prednisone, and Revlimid or after au­tol­o­gous stem cell trans­plan­ta­tion. Currently, Revlimid is approved in com­bi­na­tion with dexa­meth­a­sone for the treat­ment of patients who have received at least one prior ther­apy. For more in­for­ma­tion, please see the Celgene press release.

ENMD-2076 Is Safe In Relapsed/Refractory Multiple Myeloma (ASH 2010) – The inves­ti­ga­tional drug ENMD-2076, which is being devel­oped by the pharma­ceu­tical com­pany EntreMed, is safe in re­lapsed / refractory multiple myeloma patients, according to the interim Phase 1 trial results presented at the 2010 Meeting of the American Society of Hematology (ASH). Researchers tested four dif­fer­en­t dose levels (150 mg to 400 mg) in 28-day cycles. They observed pro­gres­sion of disease for all patients receiving the minimum dose of 150 mg. Patients receiving a dose of 300 mg achieved stable disease with reductions in serum M-protein. Researchers did not observe any dose-limiting side effects. Most side effects were mild to mod­er­ate and in­cluded nausea, diarrhea, and fatigue. The optimal dosage has not yet been de­ter­mined as the trial is still ongoing.  For more in­for­ma­tion, please see abstract 1957 on the ASH annual meeting website and the clinical trial description.

Daratumumab Emerges As Potential Treatment In CD38-Positive Multiple Myeloma – Preclinical results showed that the experimental drug dara­tu­mu­mab is highly effective at killing can­cer­ous cells that produce the CD38 molecule. The Danish bio­technology com­pany Genmab is cur­rently devel­op­ing dara­tu­mu­mab for treat­ment of CD38-positive multiple myeloma tumors. Researchers initially tested a broad array of CD38 anti­bodies against more than 10 pri­mary tumors from myeloma patients, and dara­tu­mu­mab was found to be the most effective at executing the immune sys­tem killing mech­a­nisms. Genmab is cur­rently conducting a Phase 1/2 study to de­ter­mine the safety and optimal dosage of dara­tu­mu­mab. For more in­for­ma­tion, please see the study in the Journal of Immunology (abstract) and the clinical trial description.

PBOX-15 Induces Cell Death In Multiple Myeloma Cells – Preclinical results dem­onstrated that the experimental drug com­pound PBOX-15 (1,5-benzoxazepine-15), discovered by Irish clin­i­cal scientists, is a promising treat­ment for multiple myeloma. Researchers found that PBOX-15 induced cell death in four dif­fer­en­t lines of multiple myeloma cells. In two of the cell lines, PBOX-15 in­creased the number of death re­cep­tor genes to stimulate cell death. For more in­for­ma­tion, please see the study in the British Journal of Cancer (abstract).