Novartis today announced results from the Phase 3b ENEST1st study in over 1,000 patients with newly-diagnosed, BCR-ABL positive chronic myeloid leukemia (CML), confirming the benefits of first-line Tasigna treatment seen in earlier trials. The final results of this large study, conducted in 26 European countries, were presented at the 20th Congress of the European Hematology Association (EHA) in Vienna.
"These results show patients with BCR-ABL positive CML in chronic phase receiving first-line treatment with Tasigna achieved rapid and high rates of molecular response and had a very low rate of progression to advanced disease," said Dr. Andreas Hochhaus, Head of the Department of Hematology and Medical Oncology, Jena University Hospital, Germany. "These findings from 26 countries, which are a collaboration of 307 trial sites and 14 standardized laboratories monitoring the incidence of MR4.0 as primary endpoint, confirm and complement data from the pivotal ENESTnd trial."
Tasigna® (nilotinib) is approved in more than 110 countries for the treatment of chronic phase and accelerated phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to at least one prior therapy, including Glivec® (imatinib), and in more than 85 countries for the treatment of adult patients with newly diagnosed Ph+ CML in chronic phase.
