Articles tagged with: Subcutaneous Formulation
Press Releases»
- Phase III COLUMBA study comparing the subcutaneous formulation of daratumumab to the intravenous formulation in patients with relapsed or refractory multiple myeloma met both co-primary endpoints
- Results show that daratumumab administered subcutaneously was non-inferior in efficacy and pharmacokinetics as compared to daratumumab administered intravenously
- Data will be discussed with health authorities to prepare for regulatory filings in support of bringing convenience of subcutaneous daratumumab option to patients
Copenhagen, Denmark (Press Release) – Genmab A/S (Nasdaq Copenhagen: GEN) announced today topline results from the Phase III COLUMBA study (MMY3012) of subcutaneous (SC) versus intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma. The results showed that SC administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is non-inferior to IV administration of daratumumab with regard to the co-primary end points of overall response rate (ORR) and Maximum Trough concentration (Ctrough) of daratumumab on day 1 of …
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Initial results of a German clinical trial confirm previous findings that subcutaneous (under-the-skin) injections of Velcade for the treatment of myeloma lead to fewer side effects – but similar overall response rates – compared to intravenous (IV) infusions of the drug.
The trial results also indicate, however, that IV administration of Velcade may lead to deeper treatment responses when patients are given the drug for a limited number of treatment cycles.
The German trial is notable not just because it is the largest study to date that has directly compared subcutaneous and IV Velcade. …
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Physicians and researchers have started gathering for the 18th Congress of the European Hematology Association (EHA), which will take place in Stockholm this year. The first education and poster sessions of the meeting will take place tomorrow, Friday, June 14. Additional sessions of various kinds are scheduled for both days of the weekend, until the meeting ends early Sunday afternoon (European time).
The research presented at the meeting will cover all areas of hematology, which is the study of blood, blood-forming organs, and blood-related diseases, including multiple myeloma.
The EHA meeting is …
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Subcutaneous Velcade Receives Approval In Europe For Multiple Myeloma – Janssen-Cilag, the company that markets Velcade (bortezomib) in Europe, announced on Friday that the European Medicines Agency has granted marketing authorization of subcutaneous Velcade. The decision was based on results of a Phase 3 study demonstrating that subcutaneous Velcade is as effective as intravenous Velcade but associated with fewer and less serious side effects. Europe is the third region where subcutaneous Velcade is now available; both the U.S. Food and Drug Administration and Health Canada approved the use of subcutaneous Velcade for myeloma in their respective countries earlier this year. For more information, see the press release from Janssen-Cilag or the Phase 3 results published in the journal Hematologica (abstract).
Methyljasmonate Shows Activity Against Multiple Myeloma – Results from a recent preclinical study suggest that methyljasmonate, a compound produced by plants under stressful conditions, may be active against multiple myeloma. Previous studies have shown that a related family of plant compounds called jasmonates can kill various types of cancer cells. In the current study, researchers found that methyljasmonate was able to kill myeloma cells lines and myeloma cells from patient samples at concentrations that did not affect normal stem cells. In mice that carried diffuse multiple myeloma lesions, a combination of methyljasmonate and Velcade prolonged overall survival time more than either drug alone. For more information, please see the study in the British Journal of Hematology (abstract).
Phase 1/2 Clinical Trial To Study Rapamune-Hydroxychloroquine Combination In Relapsed And Refractory Myeloma Patients – The Knight Cancer Institute at the Oregon Health and Science University is starting a Phase 1 trial of Rapamune (sirolimus or rapamycin) and hydroxychloroquine (Plaquenil) in combination with cyclophosphamide (Cytoxan) and dexamethasone (Decadron) in relapsed and refractory multiple myeloma patients. Myeloma patients must have received at least one prior therapy to be able to participate in the trial. Rapamune belongs to the same class of drugs as Torisel (temsirolimus) and Afinitor (everolimus) called mTor inhibitors; it is currently approved for the prevention of kidney rejection. Hydroxychloroquine is used to prevent and treat malaria and to treat rheumatoid arthritis. Both agents have been studied in preclinical studies for multiple myeloma. For more information, please see the clinical trial description.
Donor Stem Cell Transplants May Be More Effective But Less Safe Than Autologous Transplants As Second Transplant For Myeloma Patients – Results from a recent retrospective analysis show that allogeneic (donor) stem cell transplants may be more effective but less safe than autologous (self) stem cell transplants in myeloma patients who have already received an autologous transplant. The analysis included data from 1,192 patients who received two autologous transplants and 630 patients who received one autologous transplant followed by a donor transplant. Patients in the auto/donor group received reduced-intensity chemotherapy after the autologous transplant, in preparation for the donor transplant. The results showed that patients in the auto/donor group were 1.4 times more likely than patients in the auto/auto group to achieve a complete response. However, auto/donor patients had a 3.3-fold higher risk of treatment-related death than auto/auto counterparts. Overall survival and progression-free survival were comparable between both groups of patients. For more information, please refer to the study in Bone Marrow Transplantation (abstract).
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The National Comprehensive Cancer Network (NCCN) has updated its guidelines for the treatment of multiple myeloma, and the new guidelines will be interpreted by many as a vote of confidence for Revlimid maintenance therapy.
The NCCN guidelines are followed closely by physicians and by many U.S. health insurance companies, which frequently use them when making reimbursement decisions about different cancer treatments.
The guidelines are comprised of recommendations based on the results of recent clinical trials and ongoing scientific research. A panel of specialists within the myeloma field is responsible for updating the …
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Subcutaneous Velcade Gets Positive Opinion From European Advisory Committee – An advisory committee of the European Medicines Agency (EMA) has granted a positive opinion recommending European approval of subcutaneous Velcade (bortezomib). The committee’s decision was based on results of a Phase 3 study demonstrating that subcutaneous Velcade is as effective as intravenous Velcade but associated with fewer and less serious side effects. Updated, longer-term results of the Phase 3 study were recently published in the journal Hematologica (abstract). The EMA is expected to decide whether or not to approve subcutaneous Velcade within 30 to 60 days. For information, see the press release from Janssen-Cilag, the company that markets Velcade in Europe.
Oxycontin May Reduce Peripheral Neuropathic Pain After Velcade Treatment – Results from an Italian study suggest that treatment with the pain medication Oxycontin (controlled-release oxycodone) may help control Velcade-induced peripheral neuropathic pain that is unresponsive to other pain killers. The 62 myeloma and lymphoma patients who participated in the study reported an average reduction in pain intensity from 7.6 to 1.3 (on an 11-point rating scale) after two weeks of Oxycontin treatment. The frequency of brief pain was also reduced with Oxycontin treatment. About 75 percent of the study participants found the treatment very effective or effective; 51 percent experienced slight or mild side effects. For more information, see the related journal article in Supportive Care in Cancer (abstract).
Ibrutinib (PCI-32765) Shows Activity Against Multiple Myeloma – Results from a preclinical study suggest that the investigational drug ibrutinib (PCI-32765) is active in multiple myeloma. Ibrutinib blocks activity of an enzyme called Bruton’s tyrosine kinase (Btk). Btk is present both in antibody-producing cells and in cells called osteoclasts that remove bone tissue. Ibrutinib, which is being developed by the California-based biotech company Pharmacyclics together with Johnson & Johnson, is being investigated as a potential treatment for a number of different blood cancers. Two Phase 3 clinical trials of the drug in leukemia and lymphoma patients are about to start, and a Phase 2 trial in myeloma patients is ongoing. For more information, see the preclinical study results in the journal Blood (abstract) and the clinical trial description for the Phase 2 myeloma trial.
Blood Calcium Levels May Be An Independent Prognostic Factor In Multiple Myeloma – Results from a small Mexican study suggest that calcium levels in the blood may be an independent predictor of overall survival in multiple myeloma patients. Blood calcium levels typically rise during multiple myeloma, as loss of bone structure releases calcium into the blood. In this study, researchers compared the levels of hemoglobin, platelets, calcium, and a wide range of enzymes and proteins in the blood of healthy individuals and multiple myeloma patients. The level of calcium in a myeloma patient's blood was the only factor that, on its own, correlated with overall survival. For more information, please see the study in Revista de investigación clínica (abstract).
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Health Canada Approves Subcutaneous Velcade – Janssen, the Johnson & Johnson subsidiary that markets Velcade (bortezomib) outside of the United States, announced last week that Health Canada has approved the subcutaneous (under-the-skin) administration of Velcade for the treatment of multiple myeloma. Subcutaneous Velcade has been shown to be as effective as intravenous Velcade but is associated with fewer and less severe side effects. The Canadian approval follows the approval of subcutaneous Velcade in the U.S. in January (see related Beacon news). For more information, please see the Janssen press release.
Threshold Pharmaceuticals Begins Phase 1/2 Clinical Trial Of TH-302 For Multiple Myeloma – Threshold Pharmaceuticals last week announced the start of a Phase 1/2 clinical trial of its investigational drug TH-302 for relapsed/refractory multiple myeloma. The study will evaluate the effectiveness of TH-302 alone or in combination with Velcade in myeloma patients who have received at least two prior lines of therapy. TH-302 is a drug that is activated under low oxygen level conditions, which are common in tumors and the bone marrow of people with blood cancers. It is currently also being investigated in a range of solid tumors. For more information about the study or enrollment, please see the Threshold press release or the clinical trial description.
MUC1-2-VNTR Vaccine May Be Active Against Myeloma – The results of a recent preclinical study demonstrate that the DNA vaccine MUC1-2-VNTR delays tumor growth and extends the survival time of mice with multiple myeloma. The vaccine produces an immune response that specifically targets tumors, showing promise as a potential treatment for myeloma. For more information, see the study in Oncology Reports (abstract).
Living With Myeloma Conference – On March 24, the Arizona Myeloma Network will be hosting a free, regional conference for myeloma patients, caregivers, and healthcare professionals. Presentations by myeloma experts will address developments in myeloma research, treatment issues, and supportive care services. For more information or to register, please visit the Arizona Myeloma Network website.
IMF Patient And Family Seminar – The International Myeloma Foundation (IMF) will be holding a seminar for multiple myeloma patients and their families on March 23 and 24 in Seattle, WA. Dr. Brian Durie from the Cedars-Sinai Comprehensive Cancer Center in Los Angeles, Dr. Bill Bensinger from the Fred Hutchison Cancer Research Center in Seattle, and Dr. Keith Stewart from the Mayo Clinic Arizona will present on topics including treatment advances, managing side effects, and new clinical trials. For more information or to register, please visit the IMF website.
For a more detailed listing of myeloma-related events, please check the Myeloma Beacon Events Calendar.
