(1888PressRelease)
June 05, 2009 - "Tasigna now demonstrates potential to achieve remarkable responses in newly diagnosed patients," said Gianantonio Rosti, MD, Institute of Hematology Seràgnoli, Bologna University, Bologna, Italy, and lead study investigator. "These positive data suggest that, one day, Tasigna may offer patients another front-line treatment option."
The research compared Tasigna against historical Glivec® (imatinib)* data in the treatment of patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). Findings were presented today at the 14th Congress of the European Hematology Association (EHA) in Berlin, Germany.
Traditionally with Glivec therapy, efficacy in Ph+ CML has been measured with the objective of achieving a complete cytogenetic response (CCyR), or reaching an undetectable level of Philadelphia chromosome cells in a patient's bone marrow. However, through highly sensitive measuring methods, major molecular response (MMR) has emerged as another important measure of efficacy and may be the best predictor of long-term progression-free survival.
Tasigna was specifically designed to inhibit Bcr-Abl -- the abnormal protein responsible for the uncontrolled production of white blood cells that occurs in Ph+ CML patients -- and mutations of Bcr-Abl, more effectively than Glivec. In this Phase II study, the time to achieve MMR was measured as an endpoint. The data indicate that 96% of patients taking Tasigna reached CCyR at 12 months. In this same time period, 85% of patients taking Tasigna achieved MMR. These data indicate a more rapid reduction in disease burden compared to that seen in historical studies with Glivec. In this study, Tasigna was generally well tolerated.
Results from a Phase III registration trial, ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients), evaluating Tasigna as a potential front-line therapy for certain Ph+ CML patients, are expected in early 2010.
Currently, Tasigna is approved in more than 65 countries for the treatment of adult patients with Ph+ CML in the chronic or accelerated phases who are resistant or intolerant to prior treatment, including Glivec.
Study details
The study, conducted by the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA), is an ongoing, open-label, single-stage, multicenter Phase II clinical trial, designed to evaluate the therapeutic efficacy and safety of Tasigna as a front-line treatment. Seventy-three patients with newly diagnosed Ph+ CML in early chronic phase were enrolled in the trial. After 12 months of treatment, 96% of all patients had achieved CCyR and 85% of all patients had achieved MMR.
Tasigna was generally well tolerated with most adverse events being mild and moderate. Additional research presented at EHA includes data from the largest-ever study in the second-line CML setting, which reinforce the efficacy and safety of Tasigna.
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Novartis Media Relations
Eric Althoff
Novartis Global Media Relations
+41 61 324 7999 (direct)
+41 79 593 4202 (mobile)
eric.althoff ( @ ) novartis dot com
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