Novartis’s Tasigna (nilotinib) met its primary endpoint in the first head-to-head comparison with Glivec (imatinib). The company said, Tasigna produced faster and deeper responses than Glivec 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.
ENESTnd is a phase III randomised, open-label, multicenter study comparing the efficacy and safety of Tasigna versus Glivec in adult patients with newly diagnosed Ph+ CML in chronic phase.
The study was designed to detect a difference in major molecular response (MMR) between Tasigna and Glivec after 12 months of treatment. The comparison study also met its secondary endpoint, a difference in complete cytogenetic response (CCyR) in favor of Tasigna.
Reportedly, in earlier clinical trials, molecular responses were found to be predictive of better patient outcomes, 100% of Ph+ CML patients who achieved MMR in the first 12 months of treatment survived without disease progression for at least five years. Follow up of patients in these studies is ongoing.
The company said that the 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, US.
David Epstein, president and CEO of Novartis Oncology and Novartis Molecular Diagnostics, said: “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 Glivec, with profound implications for improving patients’ outcomes. 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.”