Results from the study, the largest clinical trial to date for newly diagnosed adult patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase, showed that 90.3% of patients who were initially randomized to take Gleevec were still alive after 54 months.
The yearly risk of progressing to advanced disease fell to less than 1% in the fourth year, the lowest rate seen in the phase III study so far, suggesting that the likelihood of progression to advanced disease decreases with time in patients taking the drug.
The results also showed that 100% of patients whose disease was considered to be at an extremely low level after 12 months of treatment, were free of progression to accelerated phase or blast crisis at 54 months.
“After collecting nearly five years of data in this trial and also considering 178,000 patient years of clinical use, we see that the longer CML patients continue to take Gleevec the lower their yearly risk of progressing to accelerated phase or blast crisis,” said David Epstein, president of Novartis Oncology.