New encouraging data on the chronic lymphocytic leukemia comes from the first analysis of the study phase the three High-Tn presented at the annual meeting of the American Society of Hematology, held recently in Orlando. In particular, it is seen that the 93% of the patients treated with acalabrutinib in combination with obinutuzumab (one of the treatments of chemo-immunoterapici standard for patients suffering from chronic lymphatic leukemia) shows no signs of progression or death after 24 months of treatment. Not only that, 88% of patients treated with acalabrutinib as monotherapy shows no signs of disease progression or death after 24 months of treatment.
The data at 28 months of age
At a median follow-up of 28.3 months, acalabrutinib (an inhibitor of tyrosine kinases of the Bruton) in combination with obinutuzumab and monotherapy significantly reduced the risk of progression or death compared to chlorambucil in combination with obinutuzumab, respectively, 90% and 80%. In an analysis of exploratory, acalabrutinib showed both in combination and in monotherapy improved PFS in the subgroups of patients with a profile of high-risk disease.
Paul Ford , professor of Medical Oncology at the University Vita-Salute San Raffaele and Coordinator of the Strategic Programme for the Study of the CLL San Raffaele Hospital, commented: “the results of The Study High-Tn, that compares acalabrutinib, both as monotherapy and in combination with obinutuzumab, with a treatment regimen of chemo-immunoterapico commonly used, show clinically significant improvement of progression-free survival for elderly patients or young people with co-morbidity with chronic lymphocytic leukemia and non-pre-treated, confirming, therefore, a potential new option for first line treatment of this disease. The results of tolerability and safety-key factors for this patient population, have also proved to be encouraging in the two treatment arms with acalabrutinib”.
adverse events
After a median follow-up of two years, with 79% of patients in both arms was still in treatment with acalabrutinib as a single agent. In the arm of acalabrutinib in combination with obinutuzumab (n=178), adverse events of any grade the most common (≥30%) were headache (39,9%), diarrhea (up 38.8%), and neutropenia (31.5 percent). In the arm of acalabrutinib administered in monotherapy (n=179), adverse events of any grade the most common (≥30%) were headache (36,9%), and diarrhea (34.6 percent). In the arm of chlorambucil in combination with obinutuzumab (n=169) adverse events of any grade the most common (≥30%) were neutropenia (45,0%), infusion-related reactions (39,6%), and nausea (31.4 percent). These are results that, together with the data previously presented in the study Phase III ASCEND on the LLC relapsed or refractory, to support the recent approvals of acalabrutinib by the Food and Drug Administration (FDA) in the United States and the Australian Therapeutic Goods Administration for the treatment of adult patients with CLL or informs, lymphocytic small-cell and by Health Canada for the treatment of CLL.
chronic lymphocytic leukemia
chronic lymphocytic leukemia (CLL) is the most common type of leukemia in adults, with an estimated 191.000 new cases at the global level – of which 20.720 new cases in the United States each year, and prevalence is on the increase thanks to the introduction of new treatments. In the LLC many hematopoietic stem cells in the bone marrow become lymphocytes are abnormal and these abnormal cells are not effective against the infections. The numerical growth of these abnormal cells reduces the space for the proliferation of white blood cells, red blood cells, and platelets healthy. This may cause anemia, infection and bleeding.
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