Blinatumomab

Amgen’s Blincyto (blinatumomab) has been granted a licence extension by the Medicines and Healthcare products Regulatory Agency (MHRA) in acute lymphoblastic leukaemia (ALL). The immunotherapy has been authorised for use in adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells. Approximately 300 new adult cases of ALL, a type of blood cancer that develops in the bone marrow and can sometimes spread to other parts of the body, are diagnosed in the UK every year. B-cell ALL is the most common form of the disease, accounting for approximately 75% of cases in adults. Despite the majority of patients being in remission after induction treatment, there is an unmet need for targeted treatments that reduce the number of remaining leukaemia cells that could cause a subsequent relapse, Amgen outlined. Administered as an intravenous infusion and already approved in the UK to treat certain cases of B-ALL, Blincyto is a bispecific T-cell engager molecule designed to target CD19 surface antigens on B cells. The MHRA’s latest decision on Blincyto, which follows the US Food and Drug Administration’s approval of the drug in the same indication in June, was supported by positive results from the late-stage E1910 trial led by the ECOG-ACRIN Cancer Research Group. The study showed that Blincyto added to multiphase consolidation chemotherapy showed superior overall survival (OS) and relapse-free survival (RFS) compared chemotherapy alone in adults with Philadelphia chromosome negative CD19-positive B-ALL who were minimal residual disease negative. With a median follow-up of 4.5 years, the five-year OS was 82.4% in the Blincyto plus chemotherapy cohort versus 62.5% in the chemotherapy group, while the five-year RFS was 77% in the Blincyto/chemotherapy arm versus 60.5% for chemotherapy alone. Tony Patrikios, medical director, Amgen UK & Ireland, said: “B-cell ALL is a rare life-threatening blood cancer… The consolidation phase is a period of intense treatment and can be a worrying time for patients and their loved ones. This licence allows us to reach even more patients in the UK who are in need of frontline treatments that reduce the risk of disease relapse.”

The annual meeting of the American Society of Hematology was held from Dec. 7 to 10 in San Diego and attracted participants from around the world, including hematology specialists as well as clinical practitioners and other health care professionals. The conference featured presentations focusing on the diagnosis, treatment, and prevention of disorders affecting blood, bone marrow, and the immunologic, hemostatic, and vascular systems. In one study, Kristin A. Shimano, M.D., of the University of California, San Francisco, Benioff Children's Hospital, and colleagues found that for pediatric patients with newly diagnosed immune thrombocytopenia (ITP) within three months of diagnosis, eltrombopag leads to a more durable platelet response during weeks six 6 to 12 of treatment compared with standard treatments. The authors evaluated the use of eltrombopag (a thrombopoietin receptor agonist approved for persistent or chronic ITP) during the new-diagnosis phase and compared the responses between patients treated with eltrombopag and standard therapies (intravenous immunoglobulin, prednisone, and anti-D globulin). The researchers found that compared with those treated with standard therapies, a greater proportion of patients treated with eltrombopag had a platelet count of more than 50,000 during weeks 6 through 12 of the study without requiring a rescue therapy. "This has a huge potential to change our approach to the management of newly diagnosed pediatric ITP," Shimano said. "For patients with moderate bleeding or significant impact on quality of life due to their ITP, eltrombopag may be a good option to get the platelets to a more hemostatic level during the time that they have active ITP." Several authors disclosed financial ties to pharmaceutical and biotechnology companies, including Novartis, which manufactures eltrombopag and funded the study. Abstract No. 709 In another study, Rushad Patell, M.D., of Harvard Medical School in Boston, and colleagues found that the use of glucagon-like peptide-1 (GLP-1) receptor agonists leads to a significant reduction in the risk for blood clots among patients with type 2 diabetes. The authors compared patients who newly started a GLP-1 receptor agonist for type 2 diabetes to patients being prescribed another antidiabetic medication to assess rates of blood clots at one year. The researchers observed a 20 percent reduction in venous thromboembolism rates at 12 months. This benefit was seen across patients with different body mass index at the time of starting the study and included a breakdown for the two different types of blood clots (pulmonary embolism and deep vein thrombosis) when evaluated individually. "This was the first time this medication has been shown to impact venous thromboembolism to our knowledge," Patell said. "If these results are confirmed, they suggest that the use of these medications can have benefits beyond what has already been shown and can now include a reduction of blood clots." Two authors disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 701 Jenny Paredes, Ph.D., of the City of Hope National Medical Center in Duarte, California, and colleagues found that increasing dietary fiber intake is beneficial for the intestinal microbiome of allogeneic hematopoietic cell transplantation (allo-HCT) patients and could lead to an increase in overall survival and a reduction in acute graft-versus-host disease (GVHD). The authors assessed a preclinical mouse model of GVHD with defined diet fiber concentrations and also analyzed the dietary patterns of allo-HCT patients. The investigators found that dietary fiber intake in allo-HCT patients (days −7 to −30) positively correlated with higher overall survival, lower acute GVHD cumulative incidence, and lower gastrointestinal-GVHD cumulative incidence (landmark analysis to 24 months). In addition, fiber consumption positively correlated with microbial alpha-diversity, relative abundance of butyrate producers, and production of short chain fatty acids (SCFAs). In the murine model of GVHD post allo-HCT, the researchers determined that a diet rich in fiber (12 percent cellulose) increased survival to GVHD, led to a higher relative abundance of butyrate producers, and modulated gene expression associated with higher epithelial homeostasis and lower T-cell mediated inflammation (single cell sequencing). "Although follow-up studies on the strategies that can be used to increase dietary fiber in allo-HCT patients are in course, we would like to recommend reevaluating the nutritional plans and meals for allo-HCT patients and including multiple options of high fiber foods for every meal and beverage," Paredes said. "Increasing fiber consumption by 10 to 20 grams per day, based on our results, would lead to a more diverse microbiome, an increase in SCFA production, and consequently, to better overall survival (the Recommended Dietary Allowance for dietary fiber by the U.S. Department of Agriculture is 25 to 30 grams per day)." One author disclosed financial ties to the pharmaceutical and biotechnology industries. Abstract No. 259 ASH: Blinatumomab + Chemo Aids Survival in B-Cell Acute Lymphoblastic Leukemia THURSDAY, Dec. 12, 2024 -- For patients with newly diagnosed, standard-risk B-cell acute lymphoblastic leukemia with an average or high risk for relapse, adding blinatumomab to combination chemotherapy is associated with improved disease-free survival, according to a study published online Dec. 7 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Reduced-Dose Anticoagulants Not Noninferior for Recurrent VTE FRIDAY, Dec. 6, 2024 -- Noninferiority of reduced- versus full-dose anticoagulants cannot be proven in patients with venous thromboembolism who need extended anticoagulation, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Auto-HCT Not Beneficial for Mantle Cell Lymphoma With Undetectable Residual Disease FRIDAY, Dec. 6, 2024 -- Autologous hematopoietic cell transplant is not beneficial for patients with mantle cell lymphoma in first complete remission with undetectable minimal residual disease, according to a study to be presented at the annual meeting of the American Society of Hematology, held from Dec. 7 to 10 in San Diego. Read Full Text ASH: Complications Common With Controlled Ovarian Hyperstimulation in Sickle Cell Anemia THURSDAY, Nov. 14, 2024 -- Many individuals with sickle cell anemia undergoing controlled ovarian hyperstimulation with oocyte cryopreservation have complications, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text ASH: GLP-1 RA Use Tied to Lower Rate of Venous Thromboembolism in Diabetes THURSDAY, Nov. 14, 2024 -- For patients with type 2 diabetes mellitus, glucagon-like peptide 1 receptor agonist use is associated with a lower risk for venous thromboembolism, according to a study scheduled for presentation at the annual meeting of the American Society of Hematology, to be held from Dec. 9 to 12 in San Diego. Read Full Text Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.