Aberdeen announces positive results from viale-a (m15-656) study

Alberto announced the positive results of viale-a (m15-656) studyThe results showed that venetoclax (venclexta or venclyxto) combined with azacytidine could reduce the risk of death by 34% compared with azacytidine combined with placebo (hazard ratio [HR] = 0.66 [95% CI, 0.52 -85], P = 0.001)The median overall survival time (OS) was improved in patients treated with venetoclax and azacytidine (14.7 months in the venetoclax group and 9.6 months in the placebo group); 66.4% of patients treated with venetoclax and azacytidine received Cr + CRI, compared with 28.3% of patients treated with azacytidine and placebo< br / > Dr Neil Gallagher, chief medical officer of Aberdeen, said: "AML patients may not be able to tolerate chemotherapy because of their serious conditionThese patients face one of the most aggressive blood tumorsThe positive results of viale-a study strongly prove that the combination of venetoclax and azacytidine has a significant effect on the improvement of survival and complete remission of the first-time patients" < br / > randomized, double-blind, placebo-controlled, phase III viale-a study evaluated the efficacy and safety of venetoclax in combination with azacytidine in AML patients who were not suitable for standard induction therapyThe study reached its primary end point, which was a statistically significant improvement in median overall survival (OS) and composite remission rate (Cr + CRI)The main end points of the reference countries of the United States and the United States are OS; the common main end points of China, Japan, the European Union (EU) and the European Union reference countries are OS and Cr + CRI< br / > Dr Courtney DDiNardo, Professor of leukemia department, cancer medicine department, MD Anderson Cancer Center, said: "AML is a very challenging blood tumor with low survival rate, especially for the elderly patients who are not suitable for strong induction chemotherapy, there are not many treatment optionsThe results of viale-a study further show that venetoclax combined with azacytidine can significantly prolong the overall survival and achieve better remission rate compared with azacytidine monotherapyVenetoclax combined with azacytidine is an effective treatment for AML patients who are not treated and do not tolerate chemotherapy" < br / > this study also reached the secondary end point, in which the complete remission (CR) rate of venetoclax group was 36.7%, the partial recovery rate of CR with Hematology (CRH) was 64.7%, the composite complete remission rate (Cr + CRI) was 66.4%; the CR rate of placebo group was 17.9%, the CRH rate was 22.8%, and the Cr + CRI rate was 28.3%< br / > the safety characteristics observed in the venetoclax plus azacytidine group were generally consistent with the known safety characteristics of the two drugs< br / > AML is one of the most common acute leukemia in the world It is estimated that 160 thousand people worldwide are suffering from the disease, with a new incidence rate of 2 in 100 thousand out of every 100 thousand people AML is also one of the most difficult blood tumors to treat Although the existing diagnosis and treatment methods have made some progress, the 5-year survival rate of AML patients is still only about 28% AML usually deteriorates rapidly In addition to age and complications, not all patients can tolerate strong induction chemotherapy < br / > it is understood that in November 2018, abelvir obtained the accelerated approval of venetoclax in combination with azacytidine, dicithabine or low-dose cytarabine (LDAC) in the United States for newly diagnosed adult AML patients aged ≥ 75 years or with complications that cannot be treated with strong induction chemotherapy In addition, this indication has been approved in 19 countries and regions around the world.