Novartis has announced that its new drug Tasigna has shown a much stronger response than Gleevec, the company’s groundbreaking treatment for adults with chronic myeloid leukaemia.
During a first head-to-head comparison study, Tasigna produced a faster and deeper response than Gleevec when given as first-line therapy for newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Novartis Oncology and Novartis Molecular Diagnostics president and CEO David Epstein said that Tasigna reduces the level of Bcr-Abl faster and to a lower level than Gleevec, 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 leukaemia to nearly undetectable levels,” Epstein said.
The Phase III clinical trial, the largest global randomised comparison of two Ph+ CML oral therapies ever conducted, was designed to detect a difference in major molecular response (MMR) between Tasigna and Gleevec after 12 months.
The trial 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, showing a difference in complete cytogenetic response in favour of Tasigna.