Articles tagged with: Doxil
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Good morning, myeloma world.
We hope you had a pleasant weekend and that your new week is off to a good start.
The big news today is that Darzalex (daratumumab) has been approved in Europe as a new treatment for multiple myeloma. We will be publishing a separate news article on the approval, which was announced a few hours ago. In the meantime, you can find information about the approval in this press release from Genmab, the company that initially developed Darzalex.
The other news we have for you …
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Good morning, myeloma world.
Since the last edition of Myeloma Morning, abstracts for two important upcoming medical meetings have been made public: the American Society of Clinical Oncology (ASCO) annual meeting, which will take place June 3 through June 7 in Chicago, and the European Hematology Association (EHA) annual congress, which is scheduled for June 9 through June 12 in Copenhagen, Denmark.
The publication of the abstracts and the meetings themselves mean that there is going to be a lot of multiple myeloma-related news in the coming weeks. We will do our …
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Anti-Cancer Virus May Enhance Efficacy Of Velcade Against Myeloma – Results from a recent preclinical study in myeloma cells show that Velcade (bortezomib) inhibits replication and spread of the anti-cancer vesicular stomatitis virus (VSV). However, when both were administered to mice with multiple myeloma, the combination more effectively killed myeloma cells than either the virus or Velcade alone. The researchers conclude that these latter findings support clinical study of VSV in combination with Velcade for the treatment of myeloma. VSV, which belongs to the same family of viruses as the rabies virus, can infect insects, animals, and humans, causing flu-like illness in humans. VSV also attacks and kills cancer cells. It is currently being studied in a clinical trial for the treatment of liver cancer and in preclinical studies for melanoma, lung cancer, colon cancer, and certain brain tumors. The VSV used in the recent preclinical study was genetically modified to specifically target myeloma cells and to reduce side effects. In addition, a component was added to the virus so that spread of the virus could be monitored. For more information, see the study in Experimental Hematology (abstract).
Preclinical Study Shows BAY80-6946 May Be Effective Against Myeloma – Results from a recent preclinical study show that the compound BAY80-6946 kills multiple myeloma cells. Specifically, BAY80-6946 reduced growth of myeloma cells grown in the laboratory and cells isolated from myeloma patients by up to 50 percent. It also killed 70 percent to 87 percent of myeloma cells in mice with multiple myeloma, without observed side effects. BAY80-6946 is an investigational myeloma treatment being developed by the German pharmaceutical company Bayer. It belong to a class of drugs that block an enzyme in cancer cells known as phosphoinositide 3-kinase (PI3K). By inhibiting PI3K, BAY80-6946 disrupts the cell division cycle and causes cancer cell death. BAY80-6946 is in Phase 1 trials as a potential treatment for a variety of different solid tumors, and it is also in a Phase 2 trial for non-Hodgkin's lymphomas. Perifosine is another investigational drug that belongs to the same class of drugs as BAY80-6946. Perifosine was also being developed for the treatment of multiple myeloma; however, it lacked significant efficacy in a Phase 3 myeloma clinical trial and is no longer being studied. For more information about the BAY80-6946 study, see the related article in Blood Cancer Journal.
More Doxil Shortages Expected – Janssen Products, the manufacturer of Doxil (doxorubicin liposomal), announced in a letter to health care providers at the end of September that the supply of Doxil will be interrupted due to difficulties at their external manufacturer. Janssen expects the shortages to take effect the middle or end of October. Doxil is currently approved in combination with Velcade for previously treated multiple myeloma patients. The company asked physicians not to start any new patients on Doxil until further notice. In the meantime, Janssen is working closely with the U.S. Food and Drug Administration (FDA) to establish other ways to ensure a reliable drug supply. However, a generic version of Doxil is available since receiving FDA approval in February (see related Beacon news). The current Doxil shortage is the second in two years. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems (see related Beacon news). For more information about the current shortage, see the Janssen Products announcement (pdf) and a related FDA announcement. Updates on the situation will be available on the Doxil website.
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Researchers from the Moffitt Cancer Center recently published results from a Phase 2 clinical trial that investigated the combination of Revlimid plus Doxil and low-dose dexamethasone as initial therapy for patients with newly diagnosed multiple myeloma.
Although the results show an overall response rate of 77 percent, a median progression-free survival time of 28 months, and a one-year overall survival rate of 98 percent for the Revlimid (lenalidomide), Doxil (doxorubicin liposomal), and dexamethasone (Decadron) combination, the researchers indicate that this combination is not an improvement on …
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Results from a small Phase 2 study conducted in Italy demonstrate that sequential treatment with novel agents and autologous stem cell transplantation with intermediate-dose melphalan is a safe and effective treatment for older, newly diagnosed myeloma patients.
“This is the first study with a sequential approach of Velcade induction, autologous stem cell transplantation, and Revlimid maintenance,” said the study’s lead investigator, Dr. Antonio Palumbo of the University of Torino in Italy.
The regimen was safest in patients under the age 70; patients aged 70 years and older experienced more treatment-related side effects …
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Results of a small Phase 2 study may lead to improved outcomes for newly diagnosed patients who are unable to achieve a deep response with a Revlimid- or thalidomide-based initial therapy.
The study indicates that follow-on treatment with a Velcade-based regimen can noticeably deepen responses in these patients.
“We were certainly pleased to see that we were able to confirm our hypothesis that offering Velcade-containing, non-cross-resistant combinations to patients whose response had stalled after [Revlimid- or thalidomide-] based therapy can improve the depth of response,” said the study’s lead investigator, Dr. Ruben …
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FDA Approves Generic Doxil – The FDA recently approved a generic version of Doxil (doxorubicin liposomal), a drug used to treat several different cancers, including multiple myeloma. Doxil was in limited supply from August 2011 to October 2012 due to manufacturing problems. However, the generic version will be readily available in 20 mg or 50 mg vials. Doxil kills cancers cells by damaging their DNA. When used as a treatment for multiple myeloma, the drug is typically combined with Velcade (bortezomib). For more information, please see the related FDA press release
Researchers Develop New Technique To Identify Kyprolis-Resistant Myeloma Cells – Researchers from George Washington University have developed a new technique that can identify multiple myeloma cells resistant to treatment with Kyprolis. The technique involves the use of an imaging dye known as CDy1, which the researchers found effective for identifying myeloma cells with high levels of the gene ABCB1. The cells with high levels of ABCB1 were found, in turn, to be resistant to treatment with Kyprolis (carfilzomib). Based on their findings, the researchers conclude that their new technique may help determine whether levels of the ABCB1 gene can predict how well a multiple myeloma patient will respond to treatment with Kyprolis. For more information, please refer to the study in the American Journal of Hematology (abstract) and the related press release from George Washington University.
MGUS Patients May Have Increased Risk Of Developing MDS – Results of a recent study indicate that, compared to the general population, patients with monoclonal gammopathy of undetermined significance (MGUS) have a 2.4 times higher risk of developing the blood disorder myelodysplastic syndromes (MDS). However, the study also found that MGUS patients do not have a significantly increased risk of developing acute myeloid leukemia or acute lymphoblastic leukemia. For more information, please see the study in the journal Leukemia (abstract).
BI-505 Shows Limited Activity In Multiple Myeloma – Preliminary results from a Phase 1 clinical trial indicate that investigational drug BI-505 shows limited activity in multiple myeloma. However, the study investigators note that the drug had a favorable safety profile. Data from the trial are available for 29 myeloma patients, all of whom had at least two previous treatment regimens before entering the trial. Increasing doses of BI-505 were tested during the study, but the best response seen was stable disease for at least two months, which was observed in 24 percent of the patients. None of the trial participants achieved a partial response or better. BI-505, which is being developed by the Swedish pharmaceutical company BioInvent, is an antibody that binds selectively to myeloma cells, triggering their death. BioInvent has described the trial results as "encouraging," and plans to test the 10 mg/kg dose of BI-505 in a future Phase 2 trial. For more information, please see the BioInvent press release.
