Novartis' Tasigna capsules meets primary endpoint in comparison trial with Gleevec

Novartis announced today that Tasigna® (nilotinib) 200 mg capsules met its primary endpoint in the first head-to-head comparison with the company's groundbreaking drug Gleevec® (imatinib mesylate) tablets. Tasigna produced faster and deeper responses than Gleevec when given as first-line therapy for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Tasigna was well tolerated in the study.

The Phase III clinical trial, Evaluating Nilotinib Efficacy and Safety in Clinical Trials of Newly Diagnosed Ph+ CML Patients (ENESTnd), is the largest global randomized comparison of two oral therapies ever conducted in newly diagnosed Ph+ CML patients. Designed to detect a difference in major molecular response (MMR) between Tasigna and Gleevec after 12 months of treatment, it is also the first registration study in which molecular traces of a key biomarker specific to Ph+ CML have been used as a primary endpoint for regulatory review. The comparison study also met its secondary endpoint, a difference in complete cytogenetic response (CCyR) in favor of Tasigna.

"We developed Tasigna to be a potent and selective inhibitor of Bcr-Abl, with the goal of eliminating the underlying cause of Ph+ CML. We now know that Tasigna reduces the level of Bcr-Abl faster and to a lower level than Gleevec, with profound implications for improving patients' outcomes," said David Epstein, President and CEO of Novartis Oncology and Novartis Molecular Diagnostics. "Molecular monitoring enables us to evaluate whether patients have achieved this deep level of CML residual disease, reducing the fundamental biomarker of leukemia to nearly undetectable levels."

The blood test used to determine molecular response can detect a single cell containing traces of Bcr-Abl in up to one million normal blood cells. In addition to being simpler and less invasive for patients, the test has a much greater sensitivity than standard cytogenetic tests, which require a sample of bone marrow to be drawn for visual detection of cells containing the Ph chromosome. Molecular monitoring measures the deepest level of CML residual disease.

Details of the ENESTnd findings will be submitted as a late-breaking abstract to the 51st annual meeting of the American Society of Hematology (ASH), to take place in December in New Orleans, Louisiana, USA.

Ongoing studies of Tasigna as first-line therapy for patients with newly diagnosed Ph+ CML include the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) study, an open-label, single-stage, multicenter Phase II clinical trial; and NCT00129740, an open-label, single-center Phase II clinical trial undertaken at M.D. Anderson Cancer Center in Houston, Texas, USA. New data from the GIMEMA study presented earlier this year at the European Hematology Association (EHA) congress show that at 12 months, 85% of patients taking Tasigna achieved MMR. These data indicate a more rapid reduction in disease burden compared to that seen in previous studies with Gleevec.